Coronavirus Infection, COVID-19, SARS-CoV-2 Infection
Conditions
Keywords
COVID-19 drug treatment, RAAS
Brief summary
The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19. The primary analysis will include data from NCT05593770.
Detailed description
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes coronavirus disease 2019 (COVID-19), has resulted in a global pandemic. The clinical spectrum of COVID-19 infection is broad, encompassing asymptomatic infection, mild upper respiratory tract illness, and severe viral pneumonia with respiratory failure and death. Between 13 and 40% of patients become hospitalized, up to 30% of those hospitalized require admission for intensive care, and there is a 13% inpatient mortality rate. The reasons for hospitalization include respiratory support, as well as support for failure of other organs, including the heart and kidneys. The risk of thrombotic complications is increased, even when compared to other viral respiratory illnesses, such as influenza. While 82% of hospitalized patients with COVID-19 are ultimately discharged alive, median length of stay is 10-13 days. Early work in treating COVID-19 has focused on preventing worsening of the initial clinical presentation to prevent hospitalization and disease progression to organ failure and death. Studies conducted under this Master Host Tissue Protocol are expected to extend our knowledge of how to manage patients who are hospitalized for COVID-19 illness. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19. This Master Protocol is a randomized, placebo-controlled trial of agents targeting the host response in COVID-19 in hospitalized patients with hypoxemia. The Master Host Tissue Protocol is designed to be flexible in the number of study arms, the use of a single placebo group, and the stopping and adding of new therapies. Our primary outcome is oxygen free days through day 28. This is defined as days alive and without supplemental oxygen use during the first 28 days following randomization. Patients who die on or before day 28 are assigned -1 oxygen free days. April 20, 2022 TRV027 and TXA127 arms closed to accrual.
Interventions
DRUGTXA127
TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
DRUGTRV027
TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
DRUGPlacebo
NaCl 0.9% infused to match the duration of the agent (3 hours for TXA127 and continuous 24-hour infusion for TRV027, over 30 minutes for APN01. Orange film-coated, plain bioconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
DRUGFostamatinib
Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
Sponsors
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Sean Collins
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Which study drug arm the participant enters will be known to the research sites and the participants, but assignment to active versus placebo will be blinded. The randomized assignment, concealed from the research team, will be transmitted to the site pharmacy, who will provide study medication. The participant, treating clinicians, study personnel (other than the unblinded statistician who will prepare closed DSMB interim reports), and outcome assessors will all remain blinded to group assignment until after the database is locked and blinded analysis is completed.
Intervention model description
Participants will be randomly allocated in a two-step process: 1) The participant will first be randomized in an m:1 ratio to receive an active study drug or placebo, where m represents the number of study drug arms for which the participant is eligible. 2) The participant will then be randomly assigned with equal probability to one of the study drug arms. Participants will receive the corresponding study drug or matching placebo. Results data includes data from NCT05593770.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Hospitalized for COVID-19 2. ≥18 years of age 3. SARS-CoV-2 infection, documented by: 1. a nucleic acid test (NAT) or equivalent testing within 3 days prior to randomization OR 2. documented by NAT or equivalent testing more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non- NAT tests is maintained in Appendix E. Appendix E. Non-NAT Tests Deemed with Equivalent Specificity to NAT by the Protocol Team). 4. Hypoxemia, defined as SpO2 \<92% on room air, new receipt of supplemental oxygen to maintain SpO2 ≥92%, or increased supplemental oxygen to maintain SpO2 ≥92% for a patient on chronic oxygen therapy 5. Symptoms or signs of acute COVID-19, defined as one or more of the following: 1. cough 2. reported or documented body temperature of 100.4 degrees Fahrenheit or greater 3. shortness of breath 4. chest pain 5. infiltrates on chest imaging (x-ray, CT scan, lung ultrasound)
Exclusion criteria
1. Onset of COVID-19 symptom fulfilling inclusion criterion #5 \>14 days prior to randomization 2. Hospitalized with hypoxemia (as defined in inclusion #4) for \>72 hours prior to randomization (the 72-hour window for randomization begins when the patient first meets the hypoxemia inclusion criteria after hospital admission) 3. Pregnancy 4. Breastfeeding 5. Prisoners 6. End-stage renal disease (ESRD) on dialysis 7. Patient undergoing comfort care measures only such that treatment focuses on end-of-life symptom management over prolongation of life. 8. The treating clinician expects inability to participate in study procedures or participation would not be in the best interests of the patient 9. Known allergy/hypersensitivity to IMP or its excipients The following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Free Days Through Day 28. | Day 1 to Day 28 | This is defined as days alive and without supplemental oxygen use during the first 28 days following randomization. Patients who die on or before day 28 are assigned -1 oxygen free days. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 60-day Mortality | Day 60 | Number of patients who have died at Day 60 |
| Hospital-free Days Through Day 28 | Day 1 to Day 28 | Days alive and not hospitalized during the first 28 days following randomization. Patients who die on or before day 28 are assigned a value -1. |
| Ventilator-free Days Through Day 28 | Day 1 to Day 28 | Days alive and not receiving mechanical ventilation during the first 28 days following randomization. Patients who die on or before day 28 are assigned a value -1. |
| Respiratory Failure-free Days Through Day 28 | Day 1 to Day 28 | Days alive and not in respiratory failure during the first 28 days following randomization. A respiratory failure-free day is defined as a day alive without the use of HFNC, NIV, IMV, or (ECMO). Patients who die on or before day 28 are assigned a value -1. |
| In-hospital Mortality | Day 1 to hospital discharge or Day 90 whichever comes first | Number of patients who die during hospitalization |
| Alive and Oxygen Free at Day 14 | Day 1 to Day 14 | Number of patients oxygen free at day 14. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO). |
| Alive and Oxygen Free at Day 28 | Day 1 to Day 28 | Number of patients oxygen-free at day 28. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO). |
| Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Day 1 to Day 28 | Number of patients alive free of new invasive mechanical ventilation at day 28 |
| 28-day Mortality | Day 28 | Number of patients who have died at Day 28 |
| 90-day Mortality | Day 90 | Number of patients who have died at Day 90 |
| Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Day 14 | Number of participants who fell within the ordinal scale per the below criteria. Each row represents the country and number of participants with the score in numerical order. 1. Ambulatory - Not hospitalized and no limitation of activities 2. Ambulatory - Not hospitalized with limitation of activities or home oxygen use 3. Hospitalized Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula 6. Hospitalized Severe Disease -Invasive mechanical ventilation 7. Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO 8. Dead |
| Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Day 28 | Number of participants who fell within the ordinal scale per the below criteria. Each row represents the country and number of participants with the score in numerical order. 1. Ambulatory - Not hospitalized and no limitation of activities 2. Ambulatory - Not hospitalized with limitation of activities or home oxygen use 3. Hospitalized Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula 6. Hospitalized Severe Disease -Invasive mechanical ventilation 7. Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO 8. Dead |
| Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Day 60 | Number of participants who fell within the ordinal scale per the below criteria. Each row represents the country and number of participants with the score in numerical order. 1. Ambulatory - Not hospitalized and no limitation of activities 2. Ambulatory - Not hospitalized with limitation of activities or home oxygen use 3. Hospitalized Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula 6. Hospitalized Severe Disease -Invasive mechanical ventilation 7. Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO 8. Dead |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incident Renal Replacement Therapy During Hospitalization | Day 0 to Day 5 or hospital discharge whichever comes first | Number of participants requiring renal replacement therapy during hospitalization (when possible, at participating sites) |
| Allergic Reaction | Day 0 to Day 5 or hospital discharge whichever comes first | Number of participants with allergic reaction, including rash and angioedema |
| Hypotension | Day 0 to Day 5 or hospital discharge whichever comes first | Number of participants with hypotension defined by low arterial blood pressure leading to either \[1\] initiation or increase in vasopressor therapy, \[2\] administration of a fluid bolus of 500 ml or more, or \[3\] modification of the dose or discontinuation of the study drug. |
Countries
United States
Participant flow
Recruitment details
This adaptive platform study consisted of 3 trials, each designed to assess a candidate agent as treatment for coronavirus disease 2019 (COVID-19) in hospitalized adult patients who had severe infection with acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. The control group for each trial includes all participants that were eligible for that trial and received a placebo mimic for any of the three study agents (shared placebo).
Pre-assignment details
Adults hospitalized with COVID-19 were enrolled with no exclusions based on age, sex, race, ethnicity, severity of disease or preferred language. If a patient appeared to meet eligibility criteria, the site investigator approached the treating clinician to ask permission to approach the patient to confirm eligibility, discuss potential study recruitment, and proceed with informed consent. The eligibility criteria were verified and informed consent was obtained just prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| TXA127 (4/20/2022 Arm Closed to Accrual) An investigational peptide agonist of Mas receptors.
TXA127: TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first. | 176 |
| TXA127 Shared Placebo NaCl 0.9% infused to match the duration (3 hours) of the agent for TXA127. (3 hours for TXA127
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included. | 175 |
| TRV027 (4/20/2022 Arm Closed to Accrual) An investigational peptide biased agonist of the AT1 receptor.
TRV027: TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first. | 149 |
| TRV027 Shared Placebo NaCl 0.9% infused to match the duration(continuous 24-hour infusion) of the agent for TRV027.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included. | 147 |
| Fostamatinib An investigational oral spleen tyrosine kinase inhibitor.
Fostamatinib: Fostamatinib100-150mg orally twice daily for 14 days or 28 doses. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses. | 207 |
| Fostamatinib Shared Placebo Orange film-coated, plain biconvex tablets orally twice daily for 14 days or 28 doses for fostamatinib placebo. Study medication will be continued as an outpatient if the patient is discharged prior to completing 28 doses.
For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included. | 206 |
| Total | 1,060 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Brazil | Death | 0 | 0 | 0 | 0 | 1 | 0 |
| Italy | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 1 |
| South Africa | Death | 0 | 0 | 0 | 0 | 0 | 1 |
| South Africa | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 1 |
| Spain | Death | 0 | 0 | 0 | 0 | 0 | 2 |
| Spain | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 |
| United States | Death | 29 | 32 | 34 | 25 | 26 | 23 |
| United States | Lost to Follow-up | 15 | 10 | 13 | 5 | 19 | 20 |
| United States | Withdrawal by Subject | 8 | 3 | 3 | 3 | 8 | 4 |
Baseline characteristics
| Characteristic | Fostamatinib Shared Placebo | TXA127 (4/20/2022 Arm Closed to Accrual) | TXA127 Shared Placebo | TRV027 (4/20/2022 Arm Closed to Accrual) | TRV027 Shared Placebo | Fostamatinib | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical All Countries <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical All Countries >=65 years | 125 Participants | 55 Participants | 47 Participants | 40 Participants | 40 Participants | 119 Participants | 426 Participants |
| Age, Categorical All Countries Between 18 and 65 years | 81 Participants | 121 Participants | 128 Participants | 109 Participants | 107 Participants | 88 Participants | 634 Participants |
| Age, Categorical Brazil <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Brazil >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Brazil Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Germany <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Germany >=65 years | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical Germany Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Italy <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Italy >=65 years | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Age, Categorical Italy Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical South Africa <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical South Africa >=65 years | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Age, Categorical South Africa Between 18 and 65 years | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Age, Categorical Spain <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Spain >=65 years | 7 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 8 Participants | 15 Participants |
| Age, Categorical Spain Between 18 and 65 years | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants |
| Age, Categorical United States <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical United States >=65 years | 114 Participants | 55 Participants | 47 Participants | 40 Participants | 40 Participants | 109 Participants | 405 Participants |
| Age, Categorical United States Between 18 and 65 years | 78 Participants | 121 Participants | 128 Participants | 109 Participants | 107 Participants | 84 Participants | 627 Participants |
| Ethnicity (NIH/OMB) All Countries Hispanic or Latino | 30 Participants | 28 Participants | 26 Participants | 25 Participants | 23 Participants | 27 Participants | 159 Participants |
| Ethnicity (NIH/OMB) All Countries Not Hispanic or Latino | 165 Participants | 140 Participants | 140 Participants | 113 Participants | 116 Participants | 174 Participants | 848 Participants |
| Ethnicity (NIH/OMB) All Countries Unknown or Not Reported | 11 Participants | 8 Participants | 9 Participants | 11 Participants | 8 Participants | 6 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Brazil Hispanic or Latino | 0 Participants | — | — | — | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Brazil Not Hispanic or Latino | 0 Participants | — | — | — | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Brazil Unknown or Not Reported | 0 Participants | — | — | — | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Germany Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Germany Not Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Germany Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Italy Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Italy Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Italy Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) South Africa Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) South Africa Not Hispanic or Latino | 3 Participants | 00 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) South Africa Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Spain Hispanic or Latino | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Spain Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Spain Unknown or Not Reported | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) United States Hispanic or Latino | 25 Participants | 28 Participants | 26 Participants | 25 Participants | 23 Participants | 21 Participants | 148 Participants |
| Ethnicity (NIH/OMB) United States Not Hispanic or Latino | 161 Participants | 140 Participants | 140 Participants | 113 Participants | 116 Participants | 170 Participants | 840 Participants |
| Ethnicity (NIH/OMB) United States Unknown or Not Reported | 6 Participants | 8 Participants | 9 Participants | 11 Participants | 8 Participants | 2 Participants | 44 Participants |
| Race (NIH/OMB) All Countries American Indian or Alaska Native | 4 Participants | 5 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 15 Participants |
| Race (NIH/OMB) All Countries Asian | 6 Participants | 4 Participants | 4 Participants | 2 Participants | 3 Participants | 6 Participants | 25 Participants |
| Race (NIH/OMB) All Countries Black or African American | 23 Participants | 29 Participants | 30 Participants | 25 Participants | 22 Participants | 24 Participants | 153 Participants |
| Race (NIH/OMB) All Countries More than one race | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) All Countries Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) All Countries Unknown or Not Reported | 13 Participants | 22 Participants | 25 Participants | 19 Participants | 24 Participants | 22 Participants | 125 Participants |
| Race (NIH/OMB) All Countries White | 160 Participants | 115 Participants | 114 Participants | 101 Participants | 97 Participants | 149 Participants | 736 Participants |
| Race (NIH/OMB) Brazil American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Brazil Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Brazil Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Brazil More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Brazil Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Brazil Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Brazil White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Germany American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Germany Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Germany Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Germany More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Germany Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Germany Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Germany White | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Italy American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Italy Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Italy Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Italy More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Italy Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Italy Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Italy White | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) South Africa American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) South Africa Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) South Africa Black or African American | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) South Africa More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) South Africa Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) South Africa Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) South Africa White | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Spain American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Spain Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Spain Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Spain More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Spain Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Spain Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Spain White | 9 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 9 Participants | 18 Participants |
| Race (NIH/OMB) United States American Indian or Alaska Native | 4 Participants | 5 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 15 Participants |
| Race (NIH/OMB) United States Asian | 6 Participants | 4 Participants | 4 Participants | 2 Participants | 3 Participants | 6 Participants | 25 Participants |
| Race (NIH/OMB) United States Black or African American | 21 Participants | 29 Participants | 30 Participants | 25 Participants | 22 Participants | 22 Participants | 149 Participants |
| Race (NIH/OMB) United States More than one race | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) United States Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) United States Unknown or Not Reported | 13 Participants | 22 Participants | 25 Participants | 19 Participants | 24 Participants | 20 Participants | 123 Participants |
| Race (NIH/OMB) United States White | 148 Participants | 115 Participants | 114 Participants | 101 Participants | 97 Participants | 139 Participants | 714 Participants |
| Region of Enrollment Brazil | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants |
| Region of Enrollment Germany | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants |
| Region of Enrollment Italy | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 2 participants |
| Region of Enrollment South Africa | 3 participants | 0 participants | 0 participants | 0 participants | 0 participants | 2 participants | 5 participants |
| Region of Enrollment Spain | 9 participants | 0 participants | 0 participants | 0 participants | 0 participants | 10 participants | 19 participants |
| Region of Enrollment United States | 192 participants | 176 participants | 175 participants | 149 participants | 147 participants | 193 participants | 871 participants |
| Sex: Female, Male All Countries Female | 95 Participants | 70 Participants | 76 Participants | 54 Participants | 69 Participants | 103 Participants | 467 Participants |
| Sex: Female, Male All Countries Male | 111 Participants | 106 Participants | 99 Participants | 95 Participants | 78 Participants | 104 Participants | 593 Participants |
| Sex: Female, Male Brazil Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Brazil Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Germany Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Germany Male | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Italy Female | 1 Participants | 0 Participants | 0 Participants | — | — | 1 Participants | 2 Participants |
| Sex: Female, Male Italy Male | 0 Participants | 0 Participants | 0 Participants | — | — | 0 Participants | 0 Participants |
| Sex: Female, Male South Africa Female | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male South Africa Male | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Spain Female | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Spain Male | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male United States Female | 89 Participants | 70 Participants | 76 Participants | 54 Participants | 69 Participants | 97 Participants | 455 Participants |
| Sex: Female, Male United States Male | 103 Participants | 106 Participants | 99 Participants | 95 Participants | 78 Participants | 96 Participants | 577 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 29 / 176 | 32 / 175 | 34 / 149 | 25 / 147 | 27 / 193 | 26 / 192 |
| other Total, other adverse events | 29 / 176 | 5 / 175 | 3 / 149 | 6 / 147 | 18 / 193 | 25 / 192 |
| serious Total, serious adverse events | 8 / 176 | 4 / 175 | 6 / 149 | 2 / 147 | 16 / 193 | 44 / 192 |
Outcome results
Primary
Oxygen Free Days Through Day 28.
This is defined as days alive and without supplemental oxygen use during the first 28 days following randomization. Patients who die on or before day 28 are assigned -1 oxygen free days. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Time frame: Day 1 to Day 28
Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TXA127 (4/20/2022 Arm Closed to Accrual) | Oxygen Free Days Through Day 28. | United States | 9.0 Days | Standard Deviation 10.9 |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Oxygen Free Days Through Day 28. | All Countries | 9.0 Days | Standard Deviation 10.9 |
| TXA127 Placebo | Oxygen Free Days Through Day 28. | United States | 11.3 Days | Standard Deviation 11.5 |
| TXA127 Placebo | Oxygen Free Days Through Day 28. | All Countries | 11.3 Days | Standard Deviation 11.5 |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Oxygen Free Days Through Day 28. | All Countries | 8.1 Days | Standard Deviation 10.8 |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Oxygen Free Days Through Day 28. | United States | 8.1 Days | Standard Deviation 10.8 |
| TRV027 Placebo | Oxygen Free Days Through Day 28. | United States | 10.5 Days | Standard Deviation 11.5 |
| TRV027 Placebo | Oxygen Free Days Through Day 28. | All Countries | 10.5 Days | Standard Deviation 11.5 |
| Fostamatinib | Oxygen Free Days Through Day 28. | Brazil | -1 Days | — |
| Fostamatinib | Oxygen Free Days Through Day 28. | All Countries | 13.4 Days | Standard Deviation 12.4 |
| Fostamatinib | Oxygen Free Days Through Day 28. | Italy | 14 Days | — |
| Fostamatinib | Oxygen Free Days Through Day 28. | South Africa | 25.5 Days | Standard Deviation 3.5 |
| Fostamatinib | Oxygen Free Days Through Day 28. | Spain | 21.3 Days | Standard Deviation 8.2 |
| Fostamatinib | Oxygen Free Days Through Day 28. | United States | 12.9 Days | Standard Deviation 12.5 |
| Fostamatinib Placebo | Oxygen Free Days Through Day 28. | South Africa | 26.5 Days | Standard Deviation 0.7 |
| Fostamatinib Placebo | Oxygen Free Days Through Day 28. | United States | 13.9 Days | Standard Deviation 12 |
| Fostamatinib Placebo | Oxygen Free Days Through Day 28. | Spain | 19.5 Days | Standard Deviation 12.5 |
| Fostamatinib Placebo | Oxygen Free Days Through Day 28. | Germany | 0 Days | — |
| Fostamatinib Placebo | Oxygen Free Days Through Day 28. | All Countries | 14.2 Days | Standard Deviation 12.1 |
Secondary
28-day Mortality
Number of patients who have died at Day 28
Time frame: Day 28
Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TXA127 (4/20/2022 Arm Closed to Accrual) | 28-day Mortality | Spain | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | 28-day Mortality | All Countries | 22 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | 28-day Mortality | Brazil | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | 28-day Mortality | South Africa | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | 28-day Mortality | United States | 22 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | 28-day Mortality | Italy | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | 28-day Mortality | Germany | 0 Participants |
| TXA127 Placebo | 28-day Mortality | Germany | 0 Participants |
| TXA127 Placebo | 28-day Mortality | United States | 22 Participants |
| TXA127 Placebo | 28-day Mortality | Brazil | 0 Participants |
| TXA127 Placebo | 28-day Mortality | All Countries | 22 Participants |
| TXA127 Placebo | 28-day Mortality | South Africa | 0 Participants |
| TXA127 Placebo | 28-day Mortality | Spain | 0 Participants |
| TXA127 Placebo | 28-day Mortality | Italy | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | 28-day Mortality | Germany | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | 28-day Mortality | All Countries | 29 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | 28-day Mortality | United States | 29 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | 28-day Mortality | Spain | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | 28-day Mortality | Brazil | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | 28-day Mortality | Italy | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | 28-day Mortality | South Africa | 0 Participants |
| TRV027 Placebo | 28-day Mortality | South Africa | 0 Participants |
| TRV027 Placebo | 28-day Mortality | Brazil | 0 Participants |
| TRV027 Placebo | 28-day Mortality | Germany | 0 Participants |
| TRV027 Placebo | 28-day Mortality | United States | 18 Participants |
| TRV027 Placebo | 28-day Mortality | Italy | 0 Participants |
| TRV027 Placebo | 28-day Mortality | All Countries | 18 Participants |
| TRV027 Placebo | 28-day Mortality | Spain | 0 Participants |
| Fostamatinib | 28-day Mortality | Germany | 0 Participants |
| Fostamatinib | 28-day Mortality | South Africa | 0 Participants |
| Fostamatinib | 28-day Mortality | Italy | 0 Participants |
| Fostamatinib | 28-day Mortality | All Countries | 22 Participants |
| Fostamatinib | 28-day Mortality | United States | 21 Participants |
| Fostamatinib | 28-day Mortality | Brazil | 1 Participants |
| Fostamatinib | 28-day Mortality | Spain | 0 Participants |
| Fostamatinib Placebo | 28-day Mortality | Italy | 0 Participants |
| Fostamatinib Placebo | 28-day Mortality | Germany | 0 Participants |
| Fostamatinib Placebo | 28-day Mortality | South Africa | 0 Participants |
| Fostamatinib Placebo | 28-day Mortality | All Countries | 16 Participants |
| Fostamatinib Placebo | 28-day Mortality | United States | 15 Participants |
| Fostamatinib Placebo | 28-day Mortality | Spain | 1 Participants |
| Fostamatinib Placebo | 28-day Mortality | Brazil | 0 Participants |
Secondary
60-day Mortality
Number of patients who have died at Day 60
Time frame: Day 60
Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TXA127 (4/20/2022 Arm Closed to Accrual) | 60-day Mortality | All Countries | 26 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | 60-day Mortality | Germany | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | 60-day Mortality | United States | 26 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | 60-day Mortality | South Africa | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | 60-day Mortality | Spain | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | 60-day Mortality | Italy | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | 60-day Mortality | Brazil | 0 Participants |
| TXA127 Placebo | 60-day Mortality | United States | 29 Participants |
| TXA127 Placebo | 60-day Mortality | Brazil | 0 Participants |
| TXA127 Placebo | 60-day Mortality | Spain | 0 Participants |
| TXA127 Placebo | 60-day Mortality | Germany | 0 Participants |
| TXA127 Placebo | 60-day Mortality | All Countries | 29 Participants |
| TXA127 Placebo | 60-day Mortality | South Africa | 0 Participants |
| TXA127 Placebo | 60-day Mortality | Italy | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | 60-day Mortality | Spain | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | 60-day Mortality | United States | 33 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | 60-day Mortality | All Countries | 33 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | 60-day Mortality | Germany | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | 60-day Mortality | Italy | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | 60-day Mortality | Brazil | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | 60-day Mortality | South Africa | 0 Participants |
| TRV027 Placebo | 60-day Mortality | Brazil | 0 Participants |
| TRV027 Placebo | 60-day Mortality | All Countries | 23 Participants |
| TRV027 Placebo | 60-day Mortality | United States | 23 Participants |
| TRV027 Placebo | 60-day Mortality | Spain | 0 Participants |
| TRV027 Placebo | 60-day Mortality | Germany | 0 Participants |
| TRV027 Placebo | 60-day Mortality | Italy | 0 Participants |
| TRV027 Placebo | 60-day Mortality | South Africa | 0 Participants |
| Fostamatinib | 60-day Mortality | Spain | 0 Participants |
| Fostamatinib | 60-day Mortality | United States | 24 Participants |
| Fostamatinib | 60-day Mortality | South Africa | 0 Participants |
| Fostamatinib | 60-day Mortality | All Countries | 25 Participants |
| Fostamatinib | 60-day Mortality | Italy | 0 Participants |
| Fostamatinib | 60-day Mortality | Brazil | 1 Participants |
| Fostamatinib | 60-day Mortality | Germany | 0 Participants |
| Fostamatinib Placebo | 60-day Mortality | South Africa | 0 Participants |
| Fostamatinib Placebo | 60-day Mortality | Germany | 0 Participants |
| Fostamatinib Placebo | 60-day Mortality | Spain | 2 Participants |
| Fostamatinib Placebo | 60-day Mortality | United States | 20 Participants |
| Fostamatinib Placebo | 60-day Mortality | Italy | 0 Participants |
| Fostamatinib Placebo | 60-day Mortality | All Countries | 22 Participants |
| Fostamatinib Placebo | 60-day Mortality | Brazil | 0 Participants |
Secondary
90-day Mortality
Number of patients who have died at Day 90
Time frame: Day 90
Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TXA127 (4/20/2022 Arm Closed to Accrual) | 90-day Mortality | All Countries | 28 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | 90-day Mortality | Germany | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | 90-day Mortality | United States | 28 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | 90-day Mortality | South Africa | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | 90-day Mortality | Spain | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | 90-day Mortality | Italy | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | 90-day Mortality | Brazil | 0 Participants |
| TXA127 Placebo | 90-day Mortality | United States | 31 Participants |
| TXA127 Placebo | 90-day Mortality | Brazil | 0 Participants |
| TXA127 Placebo | 90-day Mortality | Spain | 0 Participants |
| TXA127 Placebo | 90-day Mortality | Germany | 0 Participants |
| TXA127 Placebo | 90-day Mortality | All Countries | 31 Participants |
| TXA127 Placebo | 90-day Mortality | South Africa | 0 Participants |
| TXA127 Placebo | 90-day Mortality | Italy | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | 90-day Mortality | Spain | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | 90-day Mortality | United States | 34 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | 90-day Mortality | All Countries | 34 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | 90-day Mortality | Germany | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | 90-day Mortality | Italy | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | 90-day Mortality | Brazil | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | 90-day Mortality | South Africa | 0 Participants |
| TRV027 Placebo | 90-day Mortality | Brazil | 0 Participants |
| TRV027 Placebo | 90-day Mortality | All Countries | 25 Participants |
| TRV027 Placebo | 90-day Mortality | United States | 25 Participants |
| TRV027 Placebo | 90-day Mortality | Spain | 0 Participants |
| TRV027 Placebo | 90-day Mortality | Germany | 0 Participants |
| TRV027 Placebo | 90-day Mortality | Italy | 0 Participants |
| TRV027 Placebo | 90-day Mortality | South Africa | 0 Participants |
| Fostamatinib | 90-day Mortality | Spain | 0 Participants |
| Fostamatinib | 90-day Mortality | United States | 26 Participants |
| Fostamatinib | 90-day Mortality | All Countries | 27 Participants |
| Fostamatinib | 90-day Mortality | South Africa | 0 Participants |
| Fostamatinib | 90-day Mortality | Italy | 0 Participants |
| Fostamatinib | 90-day Mortality | Brazil | 1 Participants |
| Fostamatinib | 90-day Mortality | Germany | 0 Participants |
| Fostamatinib Placebo | 90-day Mortality | South Africa | 1 Participants |
| Fostamatinib Placebo | 90-day Mortality | Germany | 0 Participants |
| Fostamatinib Placebo | 90-day Mortality | Spain | 2 Participants |
| Fostamatinib Placebo | 90-day Mortality | United States | 23 Participants |
| Fostamatinib Placebo | 90-day Mortality | All Countries | 26 Participants |
| Fostamatinib Placebo | 90-day Mortality | Italy | 0 Participants |
| Fostamatinib Placebo | 90-day Mortality | Brazil | 0 Participants |
Secondary
Alive and Free of New Invasive Mechanical Ventilation at Day 28
Number of patients alive free of new invasive mechanical ventilation at day 28
Time frame: Day 1 to Day 28
Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TXA127 (4/20/2022 Arm Closed to Accrual) | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | All Countries | 124 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Germany | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | United States | 124 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | South Africa | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Spain | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Italy | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Brazil | 0 Participants |
| TXA127 Placebo | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | United States | 128 Participants |
| TXA127 Placebo | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Brazil | 0 Participants |
| TXA127 Placebo | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Spain | 0 Participants |
| TXA127 Placebo | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Germany | 0 Participants |
| TXA127 Placebo | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | All Countries | 128 Participants |
| TXA127 Placebo | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | South Africa | 0 Participants |
| TXA127 Placebo | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Italy | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Spain | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | United States | 99 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | All Countries | 99 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Germany | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Italy | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Brazil | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | South Africa | 0 Participants |
| TRV027 Placebo | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Brazil | 0 Participants |
| TRV027 Placebo | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | All Countries | 109 Participants |
| TRV027 Placebo | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | United States | 109 Participants |
| TRV027 Placebo | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Spain | 0 Participants |
| TRV027 Placebo | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Germany | 0 Participants |
| TRV027 Placebo | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Italy | 0 Participants |
| TRV027 Placebo | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | South Africa | 0 Participants |
| Fostamatinib | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Spain | 9 Participants |
| Fostamatinib | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | United States | 148 Participants |
| Fostamatinib | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | South Africa | 2 Participants |
| Fostamatinib | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | All Countries | 160 Participants |
| Fostamatinib | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Italy | 1 Participants |
| Fostamatinib | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Brazil | 0 Participants |
| Fostamatinib | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Germany | 0 Participants |
| Fostamatinib Placebo | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | South Africa | 2 Participants |
| Fostamatinib Placebo | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Germany | 1 Participants |
| Fostamatinib Placebo | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Spain | 8 Participants |
| Fostamatinib Placebo | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | United States | 160 Participants |
| Fostamatinib Placebo | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Italy | 0 Participants |
| Fostamatinib Placebo | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | All Countries | 171 Participants |
| Fostamatinib Placebo | Alive and Free of New Invasive Mechanical Ventilation at Day 28 | Brazil | 0 Participants |
Secondary
Alive and Oxygen Free at Day 14
Number of patients oxygen free at day 14. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Time frame: Day 1 to Day 14
Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TXA127 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 14 | Spain | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 14 | Germany | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 14 | Italy | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 14 | South Africa | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 14 | Brazil | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 14 | All Countries | 60 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 14 | United States | 60 Participants |
| TXA127 Placebo | Alive and Oxygen Free at Day 14 | Germany | 0 Participants |
| TXA127 Placebo | Alive and Oxygen Free at Day 14 | Italy | 0 Participants |
| TXA127 Placebo | Alive and Oxygen Free at Day 14 | All Countries | 86 Participants |
| TXA127 Placebo | Alive and Oxygen Free at Day 14 | United States | 86 Participants |
| TXA127 Placebo | Alive and Oxygen Free at Day 14 | Spain | 0 Participants |
| TXA127 Placebo | Alive and Oxygen Free at Day 14 | South Africa | 0 Participants |
| TXA127 Placebo | Alive and Oxygen Free at Day 14 | Brazil | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 14 | Spain | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 14 | All Countries | 48 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 14 | South Africa | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 14 | Brazil | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 14 | United States | 48 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 14 | Germany | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 14 | Italy | 0 Participants |
| TRV027 Placebo | Alive and Oxygen Free at Day 14 | Brazil | 0 Participants |
| TRV027 Placebo | Alive and Oxygen Free at Day 14 | All Countries | 66 Participants |
| TRV027 Placebo | Alive and Oxygen Free at Day 14 | United States | 66 Participants |
| TRV027 Placebo | Alive and Oxygen Free at Day 14 | Spain | 0 Participants |
| TRV027 Placebo | Alive and Oxygen Free at Day 14 | Italy | 0 Participants |
| TRV027 Placebo | Alive and Oxygen Free at Day 14 | South Africa | 0 Participants |
| TRV027 Placebo | Alive and Oxygen Free at Day 14 | Germany | 0 Participants |
| Fostamatinib | Alive and Oxygen Free at Day 14 | Spain | 8 Participants |
| Fostamatinib | Alive and Oxygen Free at Day 14 | Germany | 0 Participants |
| Fostamatinib | Alive and Oxygen Free at Day 14 | United States | 103 Participants |
| Fostamatinib | Alive and Oxygen Free at Day 14 | All Countries | 113 Participants |
| Fostamatinib | Alive and Oxygen Free at Day 14 | South Africa | 2 Participants |
| Fostamatinib | Alive and Oxygen Free at Day 14 | Brazil | 0 Participants |
| Fostamatinib | Alive and Oxygen Free at Day 14 | Italy | 0 Participants |
| Fostamatinib Placebo | Alive and Oxygen Free at Day 14 | Germany | 0 Participants |
| Fostamatinib Placebo | Alive and Oxygen Free at Day 14 | Italy | 0 Participants |
| Fostamatinib Placebo | Alive and Oxygen Free at Day 14 | All Countries | 113 Participants |
| Fostamatinib Placebo | Alive and Oxygen Free at Day 14 | Spain | 6 Participants |
| Fostamatinib Placebo | Alive and Oxygen Free at Day 14 | South Africa | 2 Participants |
| Fostamatinib Placebo | Alive and Oxygen Free at Day 14 | United States | 105 Participants |
| Fostamatinib Placebo | Alive and Oxygen Free at Day 14 | Brazil | 0 Participants |
Secondary
Alive and Oxygen Free at Day 28
Number of patients oxygen-free at day 28. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Time frame: Day 1 to Day 28
Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TXA127 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 28 | All Countries | 78 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 28 | Germany | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 28 | United States | 78 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 28 | South Africa | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 28 | Spain | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 28 | Italy | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 28 | Brazil | 0 Participants |
| TXA127 Placebo | Alive and Oxygen Free at Day 28 | United States | 87 Participants |
| TXA127 Placebo | Alive and Oxygen Free at Day 28 | Brazil | 0 Participants |
| TXA127 Placebo | Alive and Oxygen Free at Day 28 | Spain | 0 Participants |
| TXA127 Placebo | Alive and Oxygen Free at Day 28 | Germany | 0 Participants |
| TXA127 Placebo | Alive and Oxygen Free at Day 28 | All Countries | 87 Participants |
| TXA127 Placebo | Alive and Oxygen Free at Day 28 | South Africa | 0 Participants |
| TXA127 Placebo | Alive and Oxygen Free at Day 28 | Italy | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 28 | Spain | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 28 | United States | 60 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 28 | All Countries | 60 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 28 | Germany | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 28 | Italy | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 28 | Brazil | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Alive and Oxygen Free at Day 28 | South Africa | 0 Participants |
| TRV027 Placebo | Alive and Oxygen Free at Day 28 | Brazil | 0 Participants |
| TRV027 Placebo | Alive and Oxygen Free at Day 28 | All Countries | 69 Participants |
| TRV027 Placebo | Alive and Oxygen Free at Day 28 | United States | 69 Participants |
| TRV027 Placebo | Alive and Oxygen Free at Day 28 | Spain | 0 Participants |
| TRV027 Placebo | Alive and Oxygen Free at Day 28 | Germany | 0 Participants |
| TRV027 Placebo | Alive and Oxygen Free at Day 28 | Italy | 0 Participants |
| TRV027 Placebo | Alive and Oxygen Free at Day 28 | South Africa | 0 Participants |
| Fostamatinib | Alive and Oxygen Free at Day 28 | Spain | 8 Participants |
| Fostamatinib | Alive and Oxygen Free at Day 28 | United States | 95 Participants |
| Fostamatinib | Alive and Oxygen Free at Day 28 | South Africa | 2 Participants |
| Fostamatinib | Alive and Oxygen Free at Day 28 | All Countries | 106 Participants |
| Fostamatinib | Alive and Oxygen Free at Day 28 | Italy | 1 Participants |
| Fostamatinib | Alive and Oxygen Free at Day 28 | Brazil | 0 Participants |
| Fostamatinib | Alive and Oxygen Free at Day 28 | Germany | 0 Participants |
| Fostamatinib Placebo | Alive and Oxygen Free at Day 28 | South Africa | 2 Participants |
| Fostamatinib Placebo | Alive and Oxygen Free at Day 28 | Germany | 0 Participants |
| Fostamatinib Placebo | Alive and Oxygen Free at Day 28 | Spain | 7 Participants |
| Fostamatinib Placebo | Alive and Oxygen Free at Day 28 | United States | 114 Participants |
| Fostamatinib Placebo | Alive and Oxygen Free at Day 28 | Italy | 0 Participants |
| Fostamatinib Placebo | Alive and Oxygen Free at Day 28 | All Countries | 123 Participants |
| Fostamatinib Placebo | Alive and Oxygen Free at Day 28 | Brazil | 0 Participants |
Secondary
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28
Number of participants who fell within the ordinal scale per the below criteria. Each row represents the country and number of participants with the score in numerical order. 1. Ambulatory - Not hospitalized and no limitation of activities 2. Ambulatory - Not hospitalized with limitation of activities or home oxygen use 3. Hospitalized Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula 6. Hospitalized Severe Disease -Invasive mechanical ventilation 7. Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO 8. Dead
Time frame: Day 28
Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=5 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=4 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=3 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=2 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=3 | 4 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=6 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=1 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=8 | 22 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=7 | 5 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=6 | 4 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=4 | 7 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=3 | 4 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=5 | 1 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=8 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=5 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=4 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=3 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=2 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=4 | 7 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=7 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=1 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=8 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=7 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=6 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=5 | 1 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=6 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=5 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=4 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=3 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=2 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=6 | 4 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=2 | 53 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=1 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=8 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=7 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=6 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=7 | 5 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=1 | 58 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=5 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=4 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=3 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=2 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=8 | 22 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=5 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=1 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=4 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=3 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=2 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=1 | 58 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=8 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=1 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=8 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=7 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=6 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=2 | 53 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=7 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=8 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=1 | 62 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=2 | 58 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=3 | 2 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=4 | 1 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=5 | 3 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=6 | 5 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=7 | 5 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=8 | 22 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=1 | 62 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=2 | 58 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=3 | 2 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=4 | 2 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=5 | 3 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=6 | 5 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=7 | 5 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=8 | 22 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=1 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=2 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=3 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=4 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=5 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=6 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=7 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=8 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=1 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=2 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=3 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=4 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=1 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=2 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=3 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=4 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=5 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=6 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=7 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=8 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=1 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=2 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=3 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=4 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=5 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=6 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=7 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=8 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=1 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=2 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=3 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=4 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=5 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=6 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=7 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=8 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=5 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=6 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=7 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=7 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=8 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=3 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=3 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=4 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=3 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=3 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=5 | 3 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=5 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=1 | 48 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=2 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=1 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=6 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=2 | 44 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=1 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=7 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=4 | 3 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=6 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=8 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=8 | 29 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=8 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=2 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=5 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=3 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=7 | 5 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=8 | 29 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=1 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=7 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=6 | 3 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=8 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=2 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=6 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=6 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=3 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=4 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=4 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=4 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=2 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=5 | 3 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=7 | 5 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=5 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=4 | 3 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=6 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=7 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=7 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=5 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=2 | 44 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=8 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=1 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=1 | 48 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=6 | 3 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=3 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=1 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=4 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=5 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=2 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=4 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=3 | 2 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=1 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=5 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=2 | 53 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=3 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=8 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=3 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=5 | 3 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=6 | 4 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=1 | 47 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=4 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=1 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=4 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=2 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=2 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=6 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=5 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=8 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=6 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=1 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=8 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=4 | 2 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=6 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=3 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=6 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=7 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=1 | 47 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=5 | 3 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=7 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=1 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=7 | 5 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=4 | 2 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=5 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=2 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=8 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=7 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=8 | 18 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=4 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=7 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=3 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=2 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=1 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=3 | 2 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=5 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=8 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=4 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=3 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=2 | 53 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=7 | 5 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=8 | 18 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=7 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=2 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=6 | 4 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=5 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=6 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=2 | 1 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=4 | 1 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=5 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=7 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=6 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=1 | 56 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=7 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=8 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=7 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=1 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=2 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=8 | 22 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=3 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=8 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=8 | 1 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=1 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=2 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=7 | 3 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=3 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=4 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=5 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=4 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=6 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=6 | 1 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=7 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=8 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=1 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=3 | 1 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=5 | 1 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=3 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=5 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=4 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=5 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=6 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=4 | 8 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=7 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=8 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=1 | 2 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=6 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=2 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=3 | 6 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=3 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=1 | 63 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=4 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=5 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=4 | 7 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=5 | 1 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=6 | 1 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=3 | 5 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=7 | 3 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=6 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=8 | 21 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=1 | 7 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=2 | 76 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=2 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=2 | 75 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=2 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=7 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=5 | 2 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=1 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=7 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=4 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=7 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=8 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=7 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=4 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=3 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=5 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=2 | 88 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=6 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=1 | 6 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=4 | 3 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=6 | 1 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=5 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=4 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=3 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=2 | 85 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=5 | 2 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=3 | 2 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=2 | 1 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=7 | 2 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Germany Score=1 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=5 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=6 | 1 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=6 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=8 | 1 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=8 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=3 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=1 | 67 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=7 | 2 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=2 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=4 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=8 | 16 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=8 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=7 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=6 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=1 | 74 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=4 | 3 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=1 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=1 | 1 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | All Countries Score=3 | 3 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=2 | 2 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=5 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=5 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | United States Score=8 | 15 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=2 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Spain Score=8 | 1 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Brazil Score=6 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=4 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | Italy Score=3 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=6 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28 | South Africa Score=3 | 1 Participants |
Secondary
Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60
Number of participants who fell within the ordinal scale per the below criteria. Each row represents the country and number of participants with the score in numerical order. 1. Ambulatory - Not hospitalized and no limitation of activities 2. Ambulatory - Not hospitalized with limitation of activities or home oxygen use 3. Hospitalized Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula 6. Hospitalized Severe Disease -Invasive mechanical ventilation 7. Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO 8. Dead
Time frame: Day 60
Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=5 | 6 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=2 | 61 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=3 | 5 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=4 | 19 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=5 | 6 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=6 | 6 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=7 | 12 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=8 | 12 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=1 | 37 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=2 | 61 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=3 | 5 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=4 | 19 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=1 | 37 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=6 | 6 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=7 | 12 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=8 | 12 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=1 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=2 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=3 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=4 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=5 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=6 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=7 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=8 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=1 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=2 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=3 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=4 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=5 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=6 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=7 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=8 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=1 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=2 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=3 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=4 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=5 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=6 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=7 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=8 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=1 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=2 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=3 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=4 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=5 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=6 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=7 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=8 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=6 | 6 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=1 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=6 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=8 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=1 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=2 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=4 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=2 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=1 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=7 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=8 | 13 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=5 | 7 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=8 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=3 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=5 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=1 | 57 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=3 | 5 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=6 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=4 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=4 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=1 | 57 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=4 | 7 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=2 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=2 | 55 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=5 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=5 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=8 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=4 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=2 | 55 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=7 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=7 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=6 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=7 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=3 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=2 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=7 | 14 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=8 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=7 | 14 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=3 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=5 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=3 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=6 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=1 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=8 | 13 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=5 | 7 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=3 | 5 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=4 | 7 Participants |
| TXA127 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=6 | 9 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=6 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=1 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=8 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=2 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=3 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=4 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=6 | 5 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=7 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=5 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=6 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=7 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=3 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=7 | 14 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=2 | 50 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=6 | 5 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=8 | 21 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=1 | 31 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=1 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=8 | 21 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=5 | 7 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=2 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=3 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=4 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=3 | 2 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=4 | 8 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=4 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=5 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=6 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=7 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=3 | 2 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=8 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=8 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=1 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=4 | 8 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=1 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=2 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=5 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=3 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=2 | 50 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=4 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=2 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=5 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=7 | 14 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=6 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=1 | 31 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=7 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=5 | 7 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=8 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=7 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=3 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=1 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=1 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=6 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=3 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=7 | 14 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=6 | 4 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=8 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=2 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=4 | 6 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=2 | 48 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=8 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=6 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=2 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=3 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=8 | 21 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=8 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=5 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=5 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=7 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=4 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=7 | 14 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=6 | 4 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=5 | 6 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=4 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=6 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=5 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=3 | 3 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=4 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=4 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=4 | 6 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=5 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=6 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=3 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=1 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=1 | 45 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=2 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=2 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=7 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=5 | 6 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=3 | 3 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=7 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=1 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=1 | 45 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=8 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=2 | 48 Participants |
| TRV027 Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=8 | 11 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=5 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=1 | 45 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=2 | 76 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=2 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=3 | 15 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=4 | 19 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=5 | 3 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=6 | 4 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=7 | 3 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=8 | 10 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=3 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=1 | 5 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=2 | 2 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=3 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=4 | 1 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=5 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=6 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=4 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=7 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=8 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=1 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=2 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=3 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=4 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=5 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=6 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=7 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=8 | 1 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=1 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=2 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=6 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=3 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=4 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=8 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=5 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=6 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=7 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=8 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=7 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=1 | 53 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=2 | 79 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=3 | 15 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=4 | 20 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=1 | 2 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=5 | 3 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=6 | 4 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=7 | 3 Participants |
| Fostamatinib | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=8 | 11 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=8 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=7 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=6 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=5 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=4 | 11 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=1 | 75 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=5 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=4 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=3 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=2 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=8 | 10 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=2 | 77 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=1 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=8 | 2 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=4 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=7 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=7 | 7 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=3 | 4 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=6 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=5 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=4 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=3 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=2 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=4 | 14 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=3 | 3 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=2 | 1 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=3 | 1 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Spain Score=1 | 6 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=2 | 76 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=5 | 2 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=1 | 1 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=8 | 9 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=7 | 7 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=6 | 2 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=1 | 69 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | All Countries Score=6 | 2 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=6 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=5 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=4 | 1 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=6 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | South Africa Score=7 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=7 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=3 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=2 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=1 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Brazil Score=8 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | United States Score=5 | 2 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 60 | Germany Score=8 | 0 Participants |
Secondary
Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale
Number of participants who fell within the ordinal scale per the below criteria. Each row represents the country and number of participants with the score in numerical order. 1. Ambulatory - Not hospitalized and no limitation of activities 2. Ambulatory - Not hospitalized with limitation of activities or home oxygen use 3. Hospitalized Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula 6. Hospitalized Severe Disease -Invasive mechanical ventilation 7. Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO 8. Dead
Time frame: Day 14
Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=7 | 12 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=2 | 61 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=3 | 5 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=4 | 19 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=5 | 6 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=6 | 6 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score =7 | 12 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=8 | 12 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=1 | 37 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=2 | 61 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=3 | 5 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=4 | 19 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=5 | 6 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=6 | 6 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=1 | 37 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=8 | 12 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=1 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=2 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=3 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=4 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=5 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=6 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=7 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=8 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=1 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=2 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=3 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=4 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=5 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=6 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=7 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=8 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=1 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=2 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=3 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=4 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=5 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=6 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=7 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=8 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy=Score1 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=2 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=3 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=3 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=4 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=5 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=6 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=7 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=8 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=1 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=2 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=4 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=5 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=6 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=7 | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=8 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=4 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=3 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=2 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=4 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=4 | 7 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=8 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=2 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=1 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=1 | 57 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=5 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=3 | 5 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=8 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=7 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=6 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=2 | 53 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=7 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=1 | 57 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=5 | 7 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=8 | 13 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=6 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=5 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=3 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=1 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=6 | 6 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=8 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=7 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=4 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=3 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=3 | 5 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=7 | 14 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=2 | 55 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=2 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy=Score1 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=8 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=6 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=8 | 13 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score =7 | 14 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=7 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=6 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=5 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=4 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=1 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=6 | 6 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=3 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=2 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=5 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=1 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=2 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=5 | 7 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=8 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=7 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=6 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=5 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=3 | 0 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=4 | 7 Participants |
| TXA127 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=4 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=2 | 50 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=3 | 2 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=4 | 8 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=5 | 7 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=6 | 8 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=1 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=7 | 14 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=8 | 21 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=1 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=2 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=3 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=4 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=2 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=5 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=6 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=7 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=8 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=1 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=2 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=3 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=4 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=4 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=5 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=6 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=7 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=8 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=8 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=1 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=2 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=5 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=3 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=4 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=5 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=6 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=7 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=8 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=6 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy=Score1 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=5 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=2 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=3 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=4 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=3 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=7 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=6 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=1 | 31 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=2 | 50 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=7 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=3 | 2 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=4 | 8 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=5 | 7 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=6 | 5 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score =7 | 14 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=8 | 21 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=8 | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=1 | 31 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=6 | 4 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=6 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=2 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=8 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=8 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=8 | 11 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=8 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=7 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=8 | 11 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=4 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=1 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=6 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=2 | 48 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=8 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=8 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=6 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=5 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=1 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=3 | 3 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy=Score1 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=2 | 48 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=5 | 6 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=6 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=7 | 14 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=1 | 45 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score =7 | 14 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=2 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=5 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=1 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=4 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=7 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=2 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=1 | 45 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=5 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=3 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=4 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=2 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=3 | 3 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=3 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=7 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=4 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=7 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=2 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=6 | 4 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=3 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=4 | 6 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=5 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=3 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=3 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=4 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=5 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=5 | 6 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=1 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=6 | 0 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=4 | 6 Participants |
| TRV027 Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=7 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=4 | 1 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=1 | 53 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=3 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=7 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=4 | 19 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=8 | 11 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=2 | 79 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=1 | 2 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=3 | 15 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=6 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=2 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=5 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=7 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=4 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=3 | 15 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=8 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=3 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=5 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=1 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=4 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=2 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=5 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=5 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=3 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=8 | 10 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=3 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=2 | 76 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=4 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=6 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=6 | 4 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=7 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=8 | 1 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=8 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=6 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=7 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=7 | 1 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy=Score1 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=1 | 45 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=2 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=1 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=6 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=4 | 20 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=4 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score =7 | 3 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=3 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=1 | 6 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=8 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=6 | 4 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=5 | 3 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=2 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=5 | 3 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=8 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=5 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=2 | 3 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=7 | 0 Participants |
| Fostamatinib | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=6 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=4 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=8 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=5 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=2 | 1 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=4 | 14 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=6 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=7 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=4 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=3 | 3 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=8 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=1 | 1 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=1 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=1 | 5 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=2 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=5 | 2 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=7 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=3 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=4 | 1 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=8 | 9 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=5 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=5 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=6 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=7 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=7 | 7 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=6 | 2 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Germany Score=8 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy=Score1 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=2 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=2 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=6 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=6 | 2 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=3 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score =7 | 7 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=4 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=5 | 2 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=5 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=2 | 59 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=1 | 68 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=6 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=7 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=1 | 75 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | United States Score=4 | 11 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=2 | 77 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=8 | 10 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=5 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=6 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=7 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=8 | 1 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=4 | 2 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Alll Countries Score=3 | 4 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=1 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | South Africa Score=3 | 1 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=2 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Spain Score=3 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Italy Score=8 | 0 Participants |
| Fostamatinib Placebo | Clinical Status Assessed Using World Health Organization(WHO) 8-point Ordinal Scale | Brazil Score=3 | 0 Participants |
Secondary
Hospital-free Days Through Day 28
Days alive and not hospitalized during the first 28 days following randomization. Patients who die on or before day 28 are assigned a value -1.
Time frame: Day 1 to Day 28
Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TXA127 (4/20/2022 Arm Closed to Accrual) | Hospital-free Days Through Day 28 | United States | 9.0 Days | Standard Deviation 10.9 |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Hospital-free Days Through Day 28 | All Countries | 9.0 Days | Standard Deviation 10.9 |
| TXA127 Placebo | Hospital-free Days Through Day 28 | United States | 11.3 Days | Standard Deviation 11.5 |
| TXA127 Placebo | Hospital-free Days Through Day 28 | All Countries | 11.3 Days | Standard Deviation 11.5 |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Hospital-free Days Through Day 28 | All Countries | 8.1 Days | Standard Deviation 10.8 |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Hospital-free Days Through Day 28 | United States | 8.1 Days | Standard Deviation 10.8 |
| TRV027 Placebo | Hospital-free Days Through Day 28 | United States | 10.5 Days | Standard Deviation 11.5 |
| TRV027 Placebo | Hospital-free Days Through Day 28 | All Countries | 10.5 Days | Standard Deviation 11.5 |
| Fostamatinib | Hospital-free Days Through Day 28 | Spain | 21.3 Days | Standard Deviation 8.2 |
| Fostamatinib | Hospital-free Days Through Day 28 | All Countries | 13.4 Days | Standard Deviation 12.4 |
| Fostamatinib | Hospital-free Days Through Day 28 | United States | 12.9 Days | Standard Deviation 12.5 |
| Fostamatinib | Hospital-free Days Through Day 28 | Brazil | -1 Days | — |
| Fostamatinib | Hospital-free Days Through Day 28 | Italy | 14 Days | — |
| Fostamatinib | Hospital-free Days Through Day 28 | South Africa | 25.5 Days | Standard Deviation 3.5 |
| Fostamatinib Placebo | Hospital-free Days Through Day 28 | Germany | 0 Days | — |
| Fostamatinib Placebo | Hospital-free Days Through Day 28 | South Africa | 26.5 Days | Standard Deviation 0.7 |
| Fostamatinib Placebo | Hospital-free Days Through Day 28 | United States | 13.9 Days | Standard Deviation 12 |
| Fostamatinib Placebo | Hospital-free Days Through Day 28 | Spain | 19.5 Days | Standard Deviation 12.5 |
| Fostamatinib Placebo | Hospital-free Days Through Day 28 | All Countries | 14.2 Days | Standard Deviation 12.1 |
Secondary
In-hospital Mortality
Number of patients who die during hospitalization
Time frame: Day 1 to hospital discharge or Day 90 whichever comes first
Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TXA127 (4/20/2022 Arm Closed to Accrual) | In-hospital Mortality | All Countries | 23 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | In-hospital Mortality | Germany | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | In-hospital Mortality | United States | 23 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | In-hospital Mortality | South Africa | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | In-hospital Mortality | Spain | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | In-hospital Mortality | Italy | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | In-hospital Mortality | Brazil | 0 Participants |
| TXA127 Placebo | In-hospital Mortality | United States | 24 Participants |
| TXA127 Placebo | In-hospital Mortality | Brazil | 0 Participants |
| TXA127 Placebo | In-hospital Mortality | Spain | 0 Participants |
| TXA127 Placebo | In-hospital Mortality | Germany | 0 Participants |
| TXA127 Placebo | In-hospital Mortality | All Countries | 24 Participants |
| TXA127 Placebo | In-hospital Mortality | South Africa | 0 Participants |
| TXA127 Placebo | In-hospital Mortality | Italy | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | In-hospital Mortality | Spain | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | In-hospital Mortality | United States | 31 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | In-hospital Mortality | All Countries | 31 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | In-hospital Mortality | Germany | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | In-hospital Mortality | Italy | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | In-hospital Mortality | Brazil | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | In-hospital Mortality | South Africa | 0 Participants |
| TRV027 Placebo | In-hospital Mortality | Brazil | 0 Participants |
| TRV027 Placebo | In-hospital Mortality | All Countries | 20 Participants |
| TRV027 Placebo | In-hospital Mortality | United States | 20 Participants |
| TRV027 Placebo | In-hospital Mortality | Spain | 0 Participants |
| TRV027 Placebo | In-hospital Mortality | Germany | 0 Participants |
| TRV027 Placebo | In-hospital Mortality | Italy | 0 Participants |
| TRV027 Placebo | In-hospital Mortality | South Africa | 0 Participants |
| Fostamatinib | In-hospital Mortality | Spain | 0 Participants |
| Fostamatinib | In-hospital Mortality | United States | 22 Participants |
| Fostamatinib | In-hospital Mortality | South Africa | 0 Participants |
| Fostamatinib | In-hospital Mortality | All Countries | 23 Participants |
| Fostamatinib | In-hospital Mortality | Italy | 0 Participants |
| Fostamatinib | In-hospital Mortality | Brazil | 1 Participants |
| Fostamatinib | In-hospital Mortality | Germany | 0 Participants |
| Fostamatinib Placebo | In-hospital Mortality | South Africa | 0 Participants |
| Fostamatinib Placebo | In-hospital Mortality | Germany | 0 Participants |
| Fostamatinib Placebo | In-hospital Mortality | Spain | 1 Participants |
| Fostamatinib Placebo | In-hospital Mortality | United States | 15 Participants |
| Fostamatinib Placebo | In-hospital Mortality | Italy | 0 Participants |
| Fostamatinib Placebo | In-hospital Mortality | All Countries | 16 Participants |
| Fostamatinib Placebo | In-hospital Mortality | Brazil | 0 Participants |
Secondary
Respiratory Failure-free Days Through Day 28
Days alive and not in respiratory failure during the first 28 days following randomization. A respiratory failure-free day is defined as a day alive without the use of HFNC, NIV, IMV, or (ECMO). Patients who die on or before day 28 are assigned a value -1.
Time frame: Day 1 to Day 28
Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TXA127 (4/20/2022 Arm Closed to Accrual) | Respiratory Failure-free Days Through Day 28 | United States | 9.0 Days | Standard Deviation 10.9 |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Respiratory Failure-free Days Through Day 28 | All Countries | 9.0 Days | Standard Deviation 10.9 |
| TXA127 Placebo | Respiratory Failure-free Days Through Day 28 | United States | 11.3 Days | Standard Deviation 11.5 |
| TXA127 Placebo | Respiratory Failure-free Days Through Day 28 | All Countries | 11.3 Days | Standard Deviation 11.5 |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Respiratory Failure-free Days Through Day 28 | All Countries | 8.1 Days | Standard Deviation 10.8 |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Respiratory Failure-free Days Through Day 28 | United States | 8.1 Days | Standard Deviation 10.8 |
| TRV027 Placebo | Respiratory Failure-free Days Through Day 28 | United States | 10.5 Days | Standard Deviation 11.5 |
| TRV027 Placebo | Respiratory Failure-free Days Through Day 28 | All Countries | 10.5 Days | Standard Deviation 11.5 |
| Fostamatinib | Respiratory Failure-free Days Through Day 28 | Brazil | -1 Days | — |
| Fostamatinib | Respiratory Failure-free Days Through Day 28 | All Countries | 13.4 Days | Standard Deviation 12.4 |
| Fostamatinib | Respiratory Failure-free Days Through Day 28 | Italy | 14 Days | — |
| Fostamatinib | Respiratory Failure-free Days Through Day 28 | South Africa | 25.3 Days | Standard Deviation 3.5 |
| Fostamatinib | Respiratory Failure-free Days Through Day 28 | Spain | 21.3 Days | Standard Deviation 8.2 |
| Fostamatinib | Respiratory Failure-free Days Through Day 28 | United States | 12.9 Days | Standard Deviation 12.5 |
| Fostamatinib Placebo | Respiratory Failure-free Days Through Day 28 | South Africa | 26.5 Days | Standard Deviation 0.7 |
| Fostamatinib Placebo | Respiratory Failure-free Days Through Day 28 | United States | 13.9 Days | Standard Deviation 12 |
| Fostamatinib Placebo | Respiratory Failure-free Days Through Day 28 | Spain | 19.5 Days | Standard Deviation 12.5 |
| Fostamatinib Placebo | Respiratory Failure-free Days Through Day 28 | Germany | 0 Days | — |
| Fostamatinib Placebo | Respiratory Failure-free Days Through Day 28 | All Countries | 14.2 Days | Standard Deviation 12.1 |
Secondary
Ventilator-free Days Through Day 28
Days alive and not receiving mechanical ventilation during the first 28 days following randomization. Patients who die on or before day 28 are assigned a value -1.
Time frame: Day 1 to Day 28
Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TXA127 (4/20/2022 Arm Closed to Accrual) | Ventilator-free Days Through Day 28 | United States | 9.0 Days | Standard Deviation 10.9 |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Ventilator-free Days Through Day 28 | All Countries | 9.0 Days | Standard Deviation 10.9 |
| TXA127 Placebo | Ventilator-free Days Through Day 28 | All Countries | 11.3 Days | Standard Deviation 11.5 |
| TXA127 Placebo | Ventilator-free Days Through Day 28 | United States | 11.3 Days | Standard Deviation 11.5 |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Ventilator-free Days Through Day 28 | All Countries | 8.1 Days | Standard Deviation 10.8 |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Ventilator-free Days Through Day 28 | United States | 8.1 Days | Standard Deviation 10.8 |
| TRV027 Placebo | Ventilator-free Days Through Day 28 | United States | 10.5 Days | Standard Deviation 11.5 |
| TRV027 Placebo | Ventilator-free Days Through Day 28 | All Countries | 10.5 Days | Standard Deviation 11.5 |
| Fostamatinib | Ventilator-free Days Through Day 28 | All Countries | 12.9 Days | Standard Deviation 12.5 |
| Fostamatinib | Ventilator-free Days Through Day 28 | United States | 12.9 Days | Standard Deviation 12.5 |
| Fostamatinib | Ventilator-free Days Through Day 28 | Spain | 21.3 Days | Standard Deviation 8.2 |
| Fostamatinib | Ventilator-free Days Through Day 28 | Brazil | -1 Days | — |
| Fostamatinib | Ventilator-free Days Through Day 28 | Italy | 14 Days | — |
| Fostamatinib | Ventilator-free Days Through Day 28 | South Africa | 25.5 Days | Standard Deviation 3.5 |
| Fostamatinib Placebo | Ventilator-free Days Through Day 28 | Germany | 0 Days | — |
| Fostamatinib Placebo | Ventilator-free Days Through Day 28 | United States | 13.9 Days | Standard Deviation 12 |
| Fostamatinib Placebo | Ventilator-free Days Through Day 28 | South Africa | 26.5 Days | Standard Deviation 0.7 |
| Fostamatinib Placebo | Ventilator-free Days Through Day 28 | Spain | 19.5 Days | Standard Deviation 12.5 |
| Fostamatinib Placebo | Ventilator-free Days Through Day 28 | All Countries | 13.9 Days | Standard Deviation 12 |
Other Pre-specified
Allergic Reaction
Number of participants with allergic reaction, including rash and angioedema
Time frame: Day 0 to Day 5 or hospital discharge whichever comes first
Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TXA127 (4/20/2022 Arm Closed to Accrual) | Allergic Reaction | Brazil | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Allergic Reaction | United States | 3 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Allergic Reaction | South Africa | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Allergic Reaction | All Countries | 3 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Allergic Reaction | Italy | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Allergic Reaction | Germany | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Allergic Reaction | Spain | 0 Participants |
| TXA127 Placebo | Allergic Reaction | Brazil | 0 Participants |
| TXA127 Placebo | Allergic Reaction | Spain | 0 Participants |
| TXA127 Placebo | Allergic Reaction | All Countries | 4 Participants |
| TXA127 Placebo | Allergic Reaction | Germany | 0 Participants |
| TXA127 Placebo | Allergic Reaction | South Africa | 0 Participants |
| TXA127 Placebo | Allergic Reaction | Italy | 0 Participants |
| TXA127 Placebo | Allergic Reaction | United States | 4 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Allergic Reaction | Germany | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Allergic Reaction | All Countries | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Allergic Reaction | United States | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Allergic Reaction | Spain | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Allergic Reaction | Brazil | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Allergic Reaction | Italy | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Allergic Reaction | South Africa | 0 Participants |
| TRV027 Placebo | Allergic Reaction | All Countries | 3 Participants |
| TRV027 Placebo | Allergic Reaction | Brazil | 0 Participants |
| TRV027 Placebo | Allergic Reaction | United States | 3 Participants |
| TRV027 Placebo | Allergic Reaction | Germany | 0 Participants |
| TRV027 Placebo | Allergic Reaction | Spain | 0 Participants |
| TRV027 Placebo | Allergic Reaction | Italy | 0 Participants |
| TRV027 Placebo | Allergic Reaction | South Africa | 0 Participants |
| Fostamatinib | Allergic Reaction | Italy | 0 Participants |
| Fostamatinib | Allergic Reaction | All Countries | 3 Participants |
| Fostamatinib | Allergic Reaction | United States | 3 Participants |
| Fostamatinib | Allergic Reaction | Spain | 0 Participants |
| Fostamatinib | Allergic Reaction | Germany | 0 Participants |
| Fostamatinib | Allergic Reaction | Brazil | 0 Participants |
| Fostamatinib | Allergic Reaction | South Africa | 0 Participants |
| Fostamatinib Placebo | Allergic Reaction | All Countries | 1 Participants |
| Fostamatinib Placebo | Allergic Reaction | Brazil | 0 Participants |
| Fostamatinib Placebo | Allergic Reaction | Germany | 0 Participants |
| Fostamatinib Placebo | Allergic Reaction | United States | 1 Participants |
| Fostamatinib Placebo | Allergic Reaction | Italy | 0 Participants |
| Fostamatinib Placebo | Allergic Reaction | South Africa | 0 Participants |
| Fostamatinib Placebo | Allergic Reaction | Spain | 0 Participants |
Other Pre-specified
Hypotension
Number of participants with hypotension defined by low arterial blood pressure leading to either \[1\] initiation or increase in vasopressor therapy, \[2\] administration of a fluid bolus of 500 ml or more, or \[3\] modification of the dose or discontinuation of the study drug.
Time frame: Day 0 to Day 5 or hospital discharge whichever comes first
Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TXA127 (4/20/2022 Arm Closed to Accrual) | Hypotension | Germany | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Hypotension | Brazil | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Hypotension | United States | 31 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Hypotension | Spain | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Hypotension | All Countries | 31 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Hypotension | South Africa | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Hypotension | Italy | 0 Participants |
| TXA127 Placebo | Hypotension | Italy | 0 Participants |
| TXA127 Placebo | Hypotension | Spain | 0 Participants |
| TXA127 Placebo | Hypotension | All Countries | 31 Participants |
| TXA127 Placebo | Hypotension | United States | 31 Participants |
| TXA127 Placebo | Hypotension | Brazil | 0 Participants |
| TXA127 Placebo | Hypotension | Germany | 0 Participants |
| TXA127 Placebo | Hypotension | South Africa | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Hypotension | Spain | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Hypotension | United States | 32 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Hypotension | South Africa | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Hypotension | Italy | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Hypotension | All Countries | 32 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Hypotension | Germany | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Hypotension | Brazil | 0 Participants |
| TRV027 Placebo | Hypotension | Germany | 0 Participants |
| TRV027 Placebo | Hypotension | Spain | 0 Participants |
| TRV027 Placebo | Hypotension | Italy | 0 Participants |
| TRV027 Placebo | Hypotension | Brazil | 0 Participants |
| TRV027 Placebo | Hypotension | All Countries | 25 Participants |
| TRV027 Placebo | Hypotension | United States | 25 Participants |
| TRV027 Placebo | Hypotension | South Africa | 0 Participants |
| Fostamatinib | Hypotension | Germany | 0 Participants |
| Fostamatinib | Hypotension | Spain | 0 Participants |
| Fostamatinib | Hypotension | All Countries | 24 Participants |
| Fostamatinib | Hypotension | Brazil | 1 Participants |
| Fostamatinib | Hypotension | South Africa | 0 Participants |
| Fostamatinib | Hypotension | United States | 23 Participants |
| Fostamatinib | Hypotension | Italy | 0 Participants |
| Fostamatinib Placebo | Hypotension | Italy | 0 Participants |
| Fostamatinib Placebo | Hypotension | Germany | 1 Participants |
| Fostamatinib Placebo | Hypotension | South Africa | 0 Participants |
| Fostamatinib Placebo | Hypotension | All Countries | 18 Participants |
| Fostamatinib Placebo | Hypotension | Brazil | 0 Participants |
| Fostamatinib Placebo | Hypotension | Spain | 1 Participants |
| Fostamatinib Placebo | Hypotension | United States | 17 Participants |
Other Pre-specified
Incident Renal Replacement Therapy During Hospitalization
Number of participants requiring renal replacement therapy during hospitalization (when possible, at participating sites)
Time frame: Day 0 to Day 5 or hospital discharge whichever comes first
Population: Results data includes data from NCT05593770. All countries = all participant data. The 'Overall Number of Participants Analyzed' includes those with recorded outcomes, excluding ineligible participants or those who didn't receive the treatment. It reflects contributors to CT.gov outcome summaries. Some outcomes before day 90 may inflate this number. Participants who lacked outcome data were not included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TXA127 (4/20/2022 Arm Closed to Accrual) | Incident Renal Replacement Therapy During Hospitalization | All Countries | 11 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Incident Renal Replacement Therapy During Hospitalization | Germany | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Incident Renal Replacement Therapy During Hospitalization | United States | 11 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Incident Renal Replacement Therapy During Hospitalization | South Africa | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Incident Renal Replacement Therapy During Hospitalization | Spain | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Incident Renal Replacement Therapy During Hospitalization | Italy | 0 Participants |
| TXA127 (4/20/2022 Arm Closed to Accrual) | Incident Renal Replacement Therapy During Hospitalization | Brazil | 0 Participants |
| TXA127 Placebo | Incident Renal Replacement Therapy During Hospitalization | United States | 12 Participants |
| TXA127 Placebo | Incident Renal Replacement Therapy During Hospitalization | Brazil | 0 Participants |
| TXA127 Placebo | Incident Renal Replacement Therapy During Hospitalization | Spain | 0 Participants |
| TXA127 Placebo | Incident Renal Replacement Therapy During Hospitalization | Germany | 0 Participants |
| TXA127 Placebo | Incident Renal Replacement Therapy During Hospitalization | All Countries | 12 Participants |
| TXA127 Placebo | Incident Renal Replacement Therapy During Hospitalization | South Africa | 0 Participants |
| TXA127 Placebo | Incident Renal Replacement Therapy During Hospitalization | Italy | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Incident Renal Replacement Therapy During Hospitalization | Spain | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Incident Renal Replacement Therapy During Hospitalization | United States | 9 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Incident Renal Replacement Therapy During Hospitalization | All Countries | 9 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Incident Renal Replacement Therapy During Hospitalization | Germany | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Incident Renal Replacement Therapy During Hospitalization | Italy | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Incident Renal Replacement Therapy During Hospitalization | Brazil | 0 Participants |
| TRV027 (4/20/2022 Arm Closed to Accrual) | Incident Renal Replacement Therapy During Hospitalization | South Africa | 0 Participants |
| TRV027 Placebo | Incident Renal Replacement Therapy During Hospitalization | Brazil | 0 Participants |
| TRV027 Placebo | Incident Renal Replacement Therapy During Hospitalization | All Countries | 11 Participants |
| TRV027 Placebo | Incident Renal Replacement Therapy During Hospitalization | United States | 11 Participants |
| TRV027 Placebo | Incident Renal Replacement Therapy During Hospitalization | Spain | 0 Participants |
| TRV027 Placebo | Incident Renal Replacement Therapy During Hospitalization | Germany | 0 Participants |
| TRV027 Placebo | Incident Renal Replacement Therapy During Hospitalization | Italy | 0 Participants |
| TRV027 Placebo | Incident Renal Replacement Therapy During Hospitalization | South Africa | 0 Participants |
| Fostamatinib | Incident Renal Replacement Therapy During Hospitalization | Spain | 0 Participants |
| Fostamatinib | Incident Renal Replacement Therapy During Hospitalization | United States | 15 Participants |
| Fostamatinib | Incident Renal Replacement Therapy During Hospitalization | South Africa | 0 Participants |
| Fostamatinib | Incident Renal Replacement Therapy During Hospitalization | All Countries | 5 Participants |
| Fostamatinib | Incident Renal Replacement Therapy During Hospitalization | Italy | 0 Participants |
| Fostamatinib | Incident Renal Replacement Therapy During Hospitalization | Brazil | 0 Participants |
| Fostamatinib | Incident Renal Replacement Therapy During Hospitalization | Germany | 0 Participants |
| Fostamatinib Placebo | Incident Renal Replacement Therapy During Hospitalization | South Africa | 0 Participants |
| Fostamatinib Placebo | Incident Renal Replacement Therapy During Hospitalization | Germany | 0 Participants |
| Fostamatinib Placebo | Incident Renal Replacement Therapy During Hospitalization | Spain | 0 Participants |
| Fostamatinib Placebo | Incident Renal Replacement Therapy During Hospitalization | United States | 9 Participants |
| Fostamatinib Placebo | Incident Renal Replacement Therapy During Hospitalization | Italy | 0 Participants |
| Fostamatinib Placebo | Incident Renal Replacement Therapy During Hospitalization | All Countries | 9 Participants |
| Fostamatinib Placebo | Incident Renal Replacement Therapy During Hospitalization | Brazil | 0 Participants |