Coronavirus Disease 2019
Conditions
Keywords
SARS-CoV-2, Cytokines, Spleen Tyrosine Kinase, ARDS
Brief summary
Background: COVID-19 is a new disease caused by SARS-CoV-2 that was identified in 2019. Some people who get sick with COVID-19 become ill requiring hospitalization. There are some medicines that may help with recovery. Researchers want to see if a drug called fostamatinib may help people who are hospitalized with COVID-19. Objective: To learn if fostamatinib is safe in patients who are hospitalized with COVID-19 and gain earlier insight into whether it improves outcomes. Eligibility: Adults age 18 and older who are hospitalized with COVID-19. Design: Participants will be screened with a physical exam, including vital signs and weight. They will have a blood test and chest x-ray. They will have a COVID-19 test as a swab of either the back of the throat or the back of the nose. They will take a pregnancy test if needed. Participants will be randomly assigned, to take either fostamatinib pills or a placebo twice daily for up to 14 days in addition to standard of care for COVID-19. If they can swallow, they will take the pills by mouth with water. If they cannot swallow or are on mechanical ventilation, the pills will be crushed, mixed with water, and given through a tube placed through the nostril, or placed in the mouth, down the esophagus, and into the stomach. Blood samples will be taken daily. Participants will return to the Clinical Center for safety follow-up visits. At these visits, they will have a physical exam and blood tests. If they cannot visit the Clinical Center, they will be contacted by phone or have a telehealth visit. Participation will last for about two months
Detailed description
Coronavirus Disease 2019 (COVID-19) is the disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). SARS-CoV-2 primarily infects the upper and lower respiratory tract and can lead to acute respiratory distress syndrome (ARDS) in a subset of patients with a known high mortality rate. Additionally, some patients develop other organ dysfunction including myocardial injury, acute kidney injury, shock along with endothelial dysfunction and subsequently micro and macrovascular thrombosis. Much of the underlying pathology of SARS-CoV-2 is thought to be secondary to a dysregulated immune response and more recently a hypercoagulable state leading to immunothrombosis. Currently, two therapies have shown efficacy in large multicenter trials for the treatment of COVID-19, one of which is an antiviral (remdesivir) and the other is an immunosuppressant corticosteroid meant to dampen the immune response (dexamethasone). Spleen tyrosine kinase (SYK) is a cytoplasmic tyrosine kinase involved in the intracellular signaling pathways of many different immune cells. In this pilot study we propose to use fostamatinib (an SYK inhibitor) as a targeted therapy for the immunological complications of hospitalized patients with COVID-19. The biological mechanisms by which SYK inhibition may improve outcomes in patients with COVID-19 include the inhibition of pro-inflammatory cytokines by monocytes and macrophages, decreased production of neutrophil extracellular traps (NETs) by neutrophils, and inhibition of platelet aggregation; three pathways that are mediated through Fc receptors (FcR) recognition of antigen-antibody complexes or activation of c-type lectin receptors (CLEC). This is a randomized, double-blind, placebo-controlled trial of fostamatinib for the treatment of hospitalized patients with COVID-19. We will randomly assign fostamatinib or matched placebo (1:1) to 60 eligible COVID-19 patients who are a 5 to 7 on the 8-point scale (requiring supplemental oxygen via nasal canula or noninvasive ventilation, requiring mechanical ventilation or extracorporeal membrane oxygenation).
Interventions
DRUGPlacebo
Placebo tablets to match fostamatinib 100 mg and 150 mg will be provided.
DRUGfostamatinib
The study intervention is fostamatinib, an inhibitor of spleen tyrosine kinase that will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses. Subjects will receive standard of care and be randomized to receive fostamatinib or matching placebo.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: 1. Patient must be hospitalized, or had their inpatient stay extended, for COVID-19. 2. Age \>=18 years 3. Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. 4. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures. 5. Females of childbearing potential must agree to be abstinent or use a medical acceptable form of contraception from the time of enrollment through 30 days after last day of study drug 6. Laboratory confirmed SARS-CoV-2 RT-PCR test within 7 days of enrollment 7. Illness of any duration with SpO2 of less than 94% on room air requiring supplemental oxygen via nasal canula or non-invasive mechanical ventilation, or mechanical ventilation or ECMO (5 to 7 on the 8-point scale)
Exclusion criteria
1. ALT or AST \> 5 times the upper limit of normal (ULN) or ALT or AST \>= 3 x ULN and total bilirubin \> 2 x ULN. 2. Estimated glomerular filtration rate (eGFR) \<30ml/min 3. Pregnancy or breast feeding 4. Anticipated discharge in the next 72 hours 5. Allergy to study medication 6. Uncontrolled hypertension (systolic blood pressure \>160mmHg or diastolic blood pressure \>100mmHg) 7. Shock or hypotension at the time of enrollment 8. Neutrophil count \<1000/microliter 9. Concern for bacterial or fungal sepsis 10. Received immunomodulatory treatment within 30 days prior to enrollment e.g., Bruton's tyrosine kinase/phosphoinositide 3 kinase/Janus kinase inhibitor or cytokine-targeting biologic therapy (anti-TNF, IL-6) 11. Received a live vaccine the last 4 weeks 12. Those who were cognitively impaired or mentally disabled prior to COVID diagnosis 13. Participation in another clinical trial for the treatment of COVID-19.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With at Least 1 Serious Adverse Event | Day 29 | Number of participants with at least 1 serious adverse event by day 29 using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE is a list of common adverse event (AE) terms. Each AE term is defined and accompanied by a grading scale (1 to 5) that indicates the severity of the AE. Grading ranges from Grade 1 which is mild to Grade 5 which is death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Progress to Mechanical Ventilation | day 29 | Number of participants who progress to mechanical ventilation by day 29 |
| Number of Participants With Cumulative Clinical Endpoint of Death | day 14, day 28, day 60 | Number of Participants with Cumulative Clinical Endpoint of Death at Day 14, Day 28 and Day 60 |
| Number of Grade 3 and 4 Adverse Events Through Day 60 | Day 60 | Number of Grade 3 and 4 AE through day 60 using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE is a list of common adverse event (AE) terms. Each AE term is defined and accompanied by a grading scale (1 to 5) that indicates the severity of the AE. Grading ranges from Grade 1 which is mild to Grade 5 which is death. |
| Participant Score on Ordinal Scale | Day 15, Day 29 | Participant score on ordinal scale at day 15 and day 29. The ordinal scale is an assessment of the clinical status. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. |
| Change in C-Reactive Protein Levels From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in C-Reactive Protein (CRP) blood levels from baseline. The upper limit of normal is 5 mg/L (milligrams per liter). |
| Change in Fibrinogen Levels From Baseline. | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in Fibrinogen blood levels from baseline. The upper limit of normal is Fibrinogen 466 milligrams per decilitre (mg/dL). |
| Change in D-Dimer Levels From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in D-Dimer blood levels from baseline. The upper limit of normal is 0.50 mcg/mL (microgram per milliliter). |
| Change in Ferritin Levels From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in Ferritin levels from baseline. The upper limit of normal for Ferritin is 400 mcg/L (micrograms per liter). |
| Change in Interleukin 6 (IL6) Levels From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in Interleukin 6 (IL6) blood levels from baseline. The upper limit of normal for IL6 is 1.8 picograms per milliliter (pg/mL). |
| Number of Participants With Sustained Recoveries Defined by Ordinal Scale Score of 3 or Less | day 29 | Time to sustained recovery determined by ordinal scale score of 3 or less and defined as time to recovery \[either discharge from the hospital or hospitalization for infection control reasons only\], with the recovery status sustained through day 29. The ordinal scale is an assessment of the clinical status. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. |
| Relative Change in SpO2/FiO2 Ratio | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Relative change in PaO2/FiO2 or SpO2/FiO2 ratio. |
| Change in SOFA Score From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in SOFA score from baseline (day 1). The Sequential Organ Failure Assessment (SOFA) Score is a mortality prediction score that is based on the degree of dysfunction of six organ systems. The score is calculated on admission and every 24 hours until discharge using the worst parameters measured during the prior 24 hours. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). The worst measurement was defined as the measure that correlated to the highest number of points. The SOFA score ranges from 0 to 24. |
| Median Days on Participants Received Supplemental Oxygen | day 29 | Median days on participants received supplemental oxygen through day 29 |
| The Number of Participants That Experienced Acute Renal Failure | day 29 | The number of participants that experienced acute renal failure by day 29. Acute renal failure defined as increase in serum creatinine by ≥0.3mg/dL within 48 hours or increase in serum creatinine by ≥1.5 times baseline which is known or presumed to have occurred within the prior seven days. |
| Number of Participants That Experienced a Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) | day 29 | Number of participants that experienced a deep vein thrombosis (DVT) or pulmonary embolism (PE) by day 29 |
| Change in Absolute Lymphocyte Count Levels From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in Absolute lymphocyte count blood levels from baseline. |
| Change in Absolute Neutrophil Count Levels From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in Absolute neutrophil count blood levels from baseline. |
| Change in Platelet Count Levels From Baseline | Day 3, Day 5, Day 8, Day 11, Day 15, Day 29 | Change in Platelet count blood levels from baseline. |
| Median Days Participants Were Admitted to Intensive Care Unit | Day 29 | Median days participants were admitted to Intensive Care Unit (ICU) by day 29 |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from October 8, 2020, through March 2, 2021 across 2 centers: Inova Fairfax Hospital (Falls Church, VA) and the National Institutes of Health (NIH) Clinical Center (Bethesda, MD).
Participants by arm
| Arm | Count |
|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 Fostamatinib, will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses. | 30 |
| Placebo With Standard of Care for Treatment of COVID-19 Placebo tablets to match fostamatinib 150 mg will be provided and administered orally at a dose of 150 mg twice daily for 14 days or 28 doses. | 29 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Fostamatinib With Standard of Care for Treatment of COVID-19 | Placebo With Standard of Care for Treatment of COVID-19 | Total |
|---|---|---|---|
| Age, Continuous | 54.3 years STANDARD_DEVIATION 13.5 | 57.0 years STANDARD_DEVIATION 14.1 | 55.6 years STANDARD_DEVIATION 13.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 17 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 12 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Medication for COVID-19 other than the study drug Convalescent plasma or monoclonal antibodies | 12 participants | 13 participants | 25 participants |
| Medication for COVID-19 other than the study drug Dexamethasone or other steroids (methylprednisolone and prednisone) | 30 participants | 29 participants | 59 participants |
| Medication for COVID-19 other than the study drug Remdesivir | 30 participants | 29 participants | 59 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 11 Participants | 23 Participants |
| Race (NIH/OMB) White | 12 Participants | 11 Participants | 23 Participants |
| Region of Enrollment United States | 30 participants | 29 participants | 59 participants |
| Score on Ordinal Scale Invasive mechanical ventilation or extracorporeal membrane oxygen | 2 Participants | 2 Participants | 4 Participants |
| Score on Ordinal Scale Noninvasive ventilation or high-flow oxygen devices | 17 Participants | 15 Participants | 32 Participants |
| Score on Ordinal Scale Requiring supplemental oxygen | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Female | 8 Participants | 4 Participants | 12 Participants |
| Sex: Female, Male Male | 22 Participants | 25 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 30 | 3 / 29 |
| other Total, other adverse events | 8 / 30 | 15 / 29 |
| serious Total, serious adverse events | 5 / 30 | 10 / 29 |
Outcome results
Primary
Number of Participants With at Least 1 Serious Adverse Event
Number of participants with at least 1 serious adverse event by day 29 using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE is a list of common adverse event (AE) terms. Each AE term is defined and accompanied by a grading scale (1 to 5) that indicates the severity of the AE. Grading ranges from Grade 1 which is mild to Grade 5 which is death.
Time frame: Day 29
Population: Intention-to-treat analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Number of Participants With at Least 1 Serious Adverse Event | 3 Participants |
| Placebo With Standard of Care for Treatment of COVID-19 | Number of Participants With at Least 1 Serious Adverse Event | 6 Participants |
Secondary
Change in Absolute Lymphocyte Count Levels From Baseline
Change in Absolute lymphocyte count blood levels from baseline.
Time frame: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Population: Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Absolute Lymphocyte Count Levels From Baseline | Day 3 | 0.43 thousand cells per microliter |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Absolute Lymphocyte Count Levels From Baseline | Day 5 | 0.48 thousand cells per microliter |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Absolute Lymphocyte Count Levels From Baseline | Day 29 | 0.56 thousand cells per microliter |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Absolute Lymphocyte Count Levels From Baseline | Day 8 | 0.41 thousand cells per microliter |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Absolute Lymphocyte Count Levels From Baseline | Day 11 | 1.03 thousand cells per microliter |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Absolute Lymphocyte Count Levels From Baseline | Day 15 | 1.03 thousand cells per microliter |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Absolute Lymphocyte Count Levels From Baseline | Day 11 | 1.02 thousand cells per microliter |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Absolute Lymphocyte Count Levels From Baseline | Day 3 | 0.13 thousand cells per microliter |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Absolute Lymphocyte Count Levels From Baseline | Day 8 | 0.34 thousand cells per microliter |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Absolute Lymphocyte Count Levels From Baseline | Day 5 | 0.38 thousand cells per microliter |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Absolute Lymphocyte Count Levels From Baseline | Day 15 | 0.68 thousand cells per microliter |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Absolute Lymphocyte Count Levels From Baseline | Day 29 | 0.81 thousand cells per microliter |
Secondary
Change in Absolute Neutrophil Count Levels From Baseline
Change in Absolute neutrophil count blood levels from baseline.
Time frame: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Population: Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Absolute Neutrophil Count Levels From Baseline | Day 3 | 0.04 thousand cells per microliter |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Absolute Neutrophil Count Levels From Baseline | Day 5 | 1.53 thousand cells per microliter |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Absolute Neutrophil Count Levels From Baseline | Day 8 | 0.63 thousand cells per microliter |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Absolute Neutrophil Count Levels From Baseline | Day 11 | -0.95 thousand cells per microliter |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Absolute Neutrophil Count Levels From Baseline | Day 15 | -1.77 thousand cells per microliter |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Absolute Neutrophil Count Levels From Baseline | Day 29 | -2.54 thousand cells per microliter |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Absolute Neutrophil Count Levels From Baseline | Day 15 | -1.6 thousand cells per microliter |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Absolute Neutrophil Count Levels From Baseline | Day 3 | -0.09 thousand cells per microliter |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Absolute Neutrophil Count Levels From Baseline | Day 11 | 0.85 thousand cells per microliter |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Absolute Neutrophil Count Levels From Baseline | Day 5 | 0.94 thousand cells per microliter |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Absolute Neutrophil Count Levels From Baseline | Day 29 | -2.89 thousand cells per microliter |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Absolute Neutrophil Count Levels From Baseline | Day 8 | 2.74 thousand cells per microliter |
Secondary
Change in C-Reactive Protein Levels From Baseline
Change in C-Reactive Protein (CRP) blood levels from baseline. The upper limit of normal is 5 mg/L (milligrams per liter).
Time frame: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Population: Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in C-Reactive Protein Levels From Baseline | Day 3 | -37 mg/L (milligrams per liter) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in C-Reactive Protein Levels From Baseline | Day 5 | -34 mg/L (milligrams per liter) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in C-Reactive Protein Levels From Baseline | Day 8 | -56 mg/L (milligrams per liter) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in C-Reactive Protein Levels From Baseline | Day 11 | -52 mg/L (milligrams per liter) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in C-Reactive Protein Levels From Baseline | Day 15 | -43 mg/L (milligrams per liter) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in C-Reactive Protein Levels From Baseline | Day 29 | -65 mg/L (milligrams per liter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in C-Reactive Protein Levels From Baseline | Day 15 | -71 mg/L (milligrams per liter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in C-Reactive Protein Levels From Baseline | Day 3 | -46 mg/L (milligrams per liter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in C-Reactive Protein Levels From Baseline | Day 11 | -68 mg/L (milligrams per liter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in C-Reactive Protein Levels From Baseline | Day 5 | -51 mg/L (milligrams per liter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in C-Reactive Protein Levels From Baseline | Day 29 | -106 mg/L (milligrams per liter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in C-Reactive Protein Levels From Baseline | Day 8 | -66 mg/L (milligrams per liter) |
Secondary
Change in D-Dimer Levels From Baseline
Change in D-Dimer blood levels from baseline. The upper limit of normal is 0.50 mcg/mL (microgram per milliliter).
Time frame: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Population: Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in D-Dimer Levels From Baseline | Day 11 | -0.11 mcg/mL (microgram per milliliter) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in D-Dimer Levels From Baseline | Day 3 | -0.01 mcg/mL (microgram per milliliter) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in D-Dimer Levels From Baseline | Day 5 | -0.06 mcg/mL (microgram per milliliter) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in D-Dimer Levels From Baseline | Day 8 | -0.15 mcg/mL (microgram per milliliter) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in D-Dimer Levels From Baseline | Day 15 | -0.06 mcg/mL (microgram per milliliter) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in D-Dimer Levels From Baseline | Day 29 | -0.15 mcg/mL (microgram per milliliter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in D-Dimer Levels From Baseline | Day 15 | -0.32 mcg/mL (microgram per milliliter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in D-Dimer Levels From Baseline | Day 11 | -0.43 mcg/mL (microgram per milliliter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in D-Dimer Levels From Baseline | Day 8 | -0.24 mcg/mL (microgram per milliliter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in D-Dimer Levels From Baseline | Day 3 | -0.08 mcg/mL (microgram per milliliter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in D-Dimer Levels From Baseline | Day 29 | -0.16 mcg/mL (microgram per milliliter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in D-Dimer Levels From Baseline | Day 5 | -0.1 mcg/mL (microgram per milliliter) |
Secondary
Change in Ferritin Levels From Baseline
Change in Ferritin levels from baseline. The upper limit of normal for Ferritin is 400 mcg/L (micrograms per liter).
Time frame: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Population: Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Ferritin Levels From Baseline | Day 11 | -169 mcg/L (micrograms per liter) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Ferritin Levels From Baseline | Day 3 | -94 mcg/L (micrograms per liter) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Ferritin Levels From Baseline | Day 5 | -213 mcg/L (micrograms per liter) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Ferritin Levels From Baseline | Day 8 | -73 mcg/L (micrograms per liter) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Ferritin Levels From Baseline | Day 15 | -346 mcg/L (micrograms per liter) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Ferritin Levels From Baseline | D29 | -578 mcg/L (micrograms per liter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Ferritin Levels From Baseline | Day 15 | -561 mcg/L (micrograms per liter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Ferritin Levels From Baseline | Day 11 | -491 mcg/L (micrograms per liter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Ferritin Levels From Baseline | Day 8 | -253 mcg/L (micrograms per liter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Ferritin Levels From Baseline | Day 3 | -190 mcg/L (micrograms per liter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Ferritin Levels From Baseline | D29 | -738 mcg/L (micrograms per liter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Ferritin Levels From Baseline | Day 5 | -199 mcg/L (micrograms per liter) |
Secondary
Change in Fibrinogen Levels From Baseline.
Change in Fibrinogen blood levels from baseline. The upper limit of normal is Fibrinogen 466 milligrams per decilitre (mg/dL).
Time frame: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Population: Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Fibrinogen Levels From Baseline. | Day 3 | -60 mg/dL (milligrams per decilitre) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Fibrinogen Levels From Baseline. | Day 11 | -141 mg/dL (milligrams per decilitre) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Fibrinogen Levels From Baseline. | Day 15 | -132 mg/dL (milligrams per decilitre) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Fibrinogen Levels From Baseline. | Day 5 | -86 mg/dL (milligrams per decilitre) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Fibrinogen Levels From Baseline. | Day 29 | -113 mg/dL (milligrams per decilitre) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Fibrinogen Levels From Baseline. | Day 8 | -130 mg/dL (milligrams per decilitre) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Fibrinogen Levels From Baseline. | Day 29 | -231 mg/dL (milligrams per decilitre) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Fibrinogen Levels From Baseline. | Day 8 | -96 mg/dL (milligrams per decilitre) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Fibrinogen Levels From Baseline. | Day 3 | -65 mg/dL (milligrams per decilitre) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Fibrinogen Levels From Baseline. | Day 5 | -78 mg/dL (milligrams per decilitre) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Fibrinogen Levels From Baseline. | Day 11 | -138 mg/dL (milligrams per decilitre) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Fibrinogen Levels From Baseline. | Day 15 | -76 mg/dL (milligrams per decilitre) |
Secondary
Change in Interleukin 6 (IL6) Levels From Baseline
Change in Interleukin 6 (IL6) blood levels from baseline. The upper limit of normal for IL6 is 1.8 picograms per milliliter (pg/mL).
Time frame: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Population: Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Interleukin 6 (IL6) Levels From Baseline | Day 3 | -0.7 pg/mL (picograms per milliliter) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Interleukin 6 (IL6) Levels From Baseline | Day 8 | 0 pg/mL (picograms per milliliter) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Interleukin 6 (IL6) Levels From Baseline | Day 29 | -1.4 pg/mL (picograms per milliliter) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Interleukin 6 (IL6) Levels From Baseline | Day 11 | -0.1 pg/mL (picograms per milliliter) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Interleukin 6 (IL6) Levels From Baseline | Day 5 | -1 pg/mL (picograms per milliliter) |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Interleukin 6 (IL6) Levels From Baseline | Day 15 | -1.5 pg/mL (picograms per milliliter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Interleukin 6 (IL6) Levels From Baseline | Day 5 | 0.3 pg/mL (picograms per milliliter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Interleukin 6 (IL6) Levels From Baseline | Day 29 | -1.4 pg/mL (picograms per milliliter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Interleukin 6 (IL6) Levels From Baseline | Day 3 | 1.4 pg/mL (picograms per milliliter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Interleukin 6 (IL6) Levels From Baseline | Day 15 | -0.7 pg/mL (picograms per milliliter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Interleukin 6 (IL6) Levels From Baseline | Day 8 | -2.5 pg/mL (picograms per milliliter) |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Interleukin 6 (IL6) Levels From Baseline | Day 11 | -0.3 pg/mL (picograms per milliliter) |
Secondary
Change in Platelet Count Levels From Baseline
Change in Platelet count blood levels from baseline.
Time frame: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Population: Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Platelet Count Levels From Baseline | Day 3 | 59 thousand cells per microliter |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Platelet Count Levels From Baseline | Day 5 | 103 thousand cells per microliter |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Platelet Count Levels From Baseline | Day 8 | 145 thousand cells per microliter |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Platelet Count Levels From Baseline | Day 11 | 80 thousand cells per microliter |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Platelet Count Levels From Baseline | Day 15 | 11 thousand cells per microliter |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in Platelet Count Levels From Baseline | Day 29 | -29 thousand cells per microliter |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Platelet Count Levels From Baseline | Day 8 | 62 thousand cells per microliter |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Platelet Count Levels From Baseline | Day 3 | 58 thousand cells per microliter |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Platelet Count Levels From Baseline | Day 15 | -26 thousand cells per microliter |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Platelet Count Levels From Baseline | Day 29 | -7 thousand cells per microliter |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Platelet Count Levels From Baseline | Day 5 | 63 thousand cells per microliter |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in Platelet Count Levels From Baseline | Day 11 | 25 thousand cells per microliter |
Secondary
Change in SOFA Score From Baseline
Change in SOFA score from baseline (day 1). The Sequential Organ Failure Assessment (SOFA) Score is a mortality prediction score that is based on the degree of dysfunction of six organ systems. The score is calculated on admission and every 24 hours until discharge using the worst parameters measured during the prior 24 hours. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). The worst measurement was defined as the measure that correlated to the highest number of points. The SOFA score ranges from 0 to 24.
Time frame: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Population: Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in SOFA Score From Baseline | Day 15 | -1 score on a SOFA scale |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in SOFA Score From Baseline | Day 11 | 0 score on a SOFA scale |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in SOFA Score From Baseline | Day 8 | 0 score on a SOFA scale |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in SOFA Score From Baseline | Day 3 | 0 score on a SOFA scale |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in SOFA Score From Baseline | Day 29 | 0 score on a SOFA scale |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Change in SOFA Score From Baseline | Day 5 | 0 score on a SOFA scale |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in SOFA Score From Baseline | Day 29 | 1 score on a SOFA scale |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in SOFA Score From Baseline | Day 11 | 0 score on a SOFA scale |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in SOFA Score From Baseline | Day 15 | 0 score on a SOFA scale |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in SOFA Score From Baseline | Day 3 | 0 score on a SOFA scale |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in SOFA Score From Baseline | Day 5 | 0 score on a SOFA scale |
| Placebo With Standard of Care for Treatment of COVID-19 | Change in SOFA Score From Baseline | Day 8 | 0 score on a SOFA scale |
Secondary
Median Days on Participants Received Supplemental Oxygen
Median days on participants received supplemental oxygen through day 29
Time frame: day 29
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Median Days on Participants Received Supplemental Oxygen | 8 days |
| Placebo With Standard of Care for Treatment of COVID-19 | Median Days on Participants Received Supplemental Oxygen | 20 days |
Secondary
Median Days Participants Were Admitted to Intensive Care Unit
Median days participants were admitted to Intensive Care Unit (ICU) by day 29
Time frame: Day 29
Population: Participants admitted to Intensive Care Unit
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Median Days Participants Were Admitted to Intensive Care Unit | 3 Days |
| Placebo With Standard of Care for Treatment of COVID-19 | Median Days Participants Were Admitted to Intensive Care Unit | 7 Days |
Secondary
Number of Grade 3 and 4 Adverse Events Through Day 60
Number of Grade 3 and 4 AE through day 60 using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE is a list of common adverse event (AE) terms. Each AE term is defined and accompanied by a grading scale (1 to 5) that indicates the severity of the AE. Grading ranges from Grade 1 which is mild to Grade 5 which is death.
Time frame: Day 60
Population: Intention-to-treat analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Number of Grade 3 and 4 Adverse Events Through Day 60 | Grade 3 | 17 Adverse Events |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Number of Grade 3 and 4 Adverse Events Through Day 60 | Grade 4 | 3 Adverse Events |
| Placebo With Standard of Care for Treatment of COVID-19 | Number of Grade 3 and 4 Adverse Events Through Day 60 | Grade 3 | 23 Adverse Events |
| Placebo With Standard of Care for Treatment of COVID-19 | Number of Grade 3 and 4 Adverse Events Through Day 60 | Grade 4 | 7 Adverse Events |
Secondary
Number of Participants That Experienced a Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
Number of participants that experienced a deep vein thrombosis (DVT) or pulmonary embolism (PE) by day 29
Time frame: day 29
Population: Intent to Treat Analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Number of Participants That Experienced a Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) | 2 Participants |
| Placebo With Standard of Care for Treatment of COVID-19 | Number of Participants That Experienced a Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) | 0 Participants |
Secondary
Number of Participants Who Progress to Mechanical Ventilation
Number of participants who progress to mechanical ventilation by day 29
Time frame: day 29
Population: Participants who were not receiving mechanical ventilation at baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Number of Participants Who Progress to Mechanical Ventilation | 1 Participants |
| Placebo With Standard of Care for Treatment of COVID-19 | Number of Participants Who Progress to Mechanical Ventilation | 2 Participants |
Secondary
Number of Participants With Cumulative Clinical Endpoint of Death
Number of Participants with Cumulative Clinical Endpoint of Death at Day 14, Day 28 and Day 60
Time frame: day 14, day 28, day 60
Population: Intention-to-treat analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Number of Participants With Cumulative Clinical Endpoint of Death | day 60 | 1 Participants |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Number of Participants With Cumulative Clinical Endpoint of Death | day 14 | 0 Participants |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Number of Participants With Cumulative Clinical Endpoint of Death | day 28 | 0 Participants |
| Placebo With Standard of Care for Treatment of COVID-19 | Number of Participants With Cumulative Clinical Endpoint of Death | day 28 | 3 Participants |
| Placebo With Standard of Care for Treatment of COVID-19 | Number of Participants With Cumulative Clinical Endpoint of Death | day 60 | 3 Participants |
| Placebo With Standard of Care for Treatment of COVID-19 | Number of Participants With Cumulative Clinical Endpoint of Death | day 14 | 1 Participants |
Secondary
Number of Participants With Sustained Recoveries Defined by Ordinal Scale Score of 3 or Less
Time to sustained recovery determined by ordinal scale score of 3 or less and defined as time to recovery \[either discharge from the hospital or hospitalization for infection control reasons only\], with the recovery status sustained through day 29. The ordinal scale is an assessment of the clinical status. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time frame: day 29
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Number of Participants With Sustained Recoveries Defined by Ordinal Scale Score of 3 or Less | 27 Participants |
| Placebo With Standard of Care for Treatment of COVID-19 | Number of Participants With Sustained Recoveries Defined by Ordinal Scale Score of 3 or Less | 22 Participants |
Secondary
Participant Score on Ordinal Scale
Participant score on ordinal scale at day 15 and day 29. The ordinal scale is an assessment of the clinical status. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time frame: Day 15, Day 29
Population: intent to treat analysis
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Participant Score on Ordinal Scale | Day 15 | 1 score on a scale |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Participant Score on Ordinal Scale | Day 29 | 1 score on a scale |
| Placebo With Standard of Care for Treatment of COVID-19 | Participant Score on Ordinal Scale | Day 29 | 1 score on a scale |
| Placebo With Standard of Care for Treatment of COVID-19 | Participant Score on Ordinal Scale | Day 15 | 2 score on a scale |
Secondary
Relative Change in SpO2/FiO2 Ratio
Relative change in PaO2/FiO2 or SpO2/FiO2 ratio.
Time frame: Day 3, Day 5, Day 8, Day 11, Day 15, Day 29
Population: Only SpO2/FiO2 ratio is available as PaO2 was not consistently measured. Intent to treat analysis. 58 patients (29 in each group) provided research samples for at least one time-point since baseline except for one patient who did not take any study drug and withdrew consent after enrollment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Relative Change in SpO2/FiO2 Ratio | Day 3 | 0.87 SpO2/FiO2 ratio |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Relative Change in SpO2/FiO2 Ratio | Day 5 | 1.09 SpO2/FiO2 ratio |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Relative Change in SpO2/FiO2 Ratio | Day 8 | 0.75 SpO2/FiO2 ratio |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Relative Change in SpO2/FiO2 Ratio | Day 11 | 1.49 SpO2/FiO2 ratio |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Relative Change in SpO2/FiO2 Ratio | Day 15 | 1.23 SpO2/FiO2 ratio |
| Fostamatinib With Standard of Care for Treatment of COVID-19 | Relative Change in SpO2/FiO2 Ratio | Day 29 | 0.74 SpO2/FiO2 ratio |
| Placebo With Standard of Care for Treatment of COVID-19 | Relative Change in SpO2/FiO2 Ratio | Day 15 | 1.07 SpO2/FiO2 ratio |
| Placebo With Standard of Care for Treatment of COVID-19 | Relative Change in SpO2/FiO2 Ratio | Day 3 | 0.93 SpO2/FiO2 ratio |
| Placebo With Standard of Care for Treatment of COVID-19 | Relative Change in SpO2/FiO2 Ratio | Day 11 | 0.99 SpO2/FiO2 ratio |
| Placebo With Standard of Care for Treatment of COVID-19 | Relative Change in SpO2/FiO2 Ratio | Day 5 | 0.88 SpO2/FiO2 ratio |
| Placebo With Standard of Care for Treatment of COVID-19 | Relative Change in SpO2/FiO2 Ratio | Day 29 | 0.49 SpO2/FiO2 ratio |
| Placebo With Standard of Care for Treatment of COVID-19 | Relative Change in SpO2/FiO2 Ratio | Day 8 | 1.09 SpO2/FiO2 ratio |
Secondary
The Number of Participants That Experienced Acute Renal Failure
The number of participants that experienced acute renal failure by day 29. Acute renal failure defined as increase in serum creatinine by ≥0.3mg/dL within 48 hours or increase in serum creatinine by ≥1.5 times baseline which is known or presumed to have occurred within the prior seven days.
Time frame: day 29
Population: Intent to treat analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fostamatinib With Standard of Care for Treatment of COVID-19 | The Number of Participants That Experienced Acute Renal Failure | 3 Participants |
| Placebo With Standard of Care for Treatment of COVID-19 | The Number of Participants That Experienced Acute Renal Failure | 5 Participants |