Covid19
Conditions
Keywords
COVID-19, BGE-175, BioAge, Respiratory failure
Brief summary
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of BGE-175 in participants ≥ 50 years of age hospitalized with documented COVID-19.
Detailed description
This is a randomized, placebo-controlled, parallel-group, multicenter, double-blind study of BGE-175 administered PO or NG in participants ≥ 50 years of age and hospitalized with documented COVID-19 who are not yet in respiratory failure. After signing informed consent, participants will be screened upon presentation at the hospital. Screening will include full physical examination, vital signs, safety laboratory evaluation, oxygen saturation, pre-diagnostics to measure prostaglandin D2 (PGD2) status, and baseline assessment of World Health Organization (WHO) Ordinal Scale for COVID-19. If confirmed that the participant qualifies for this protocol according to listed inclusion and exclusion criteria, participants will receive the first dose of study medication, PO. The participant will then receive study medication PO or NG (if intubated or unable to swallow medication) once daily, at approximately the same time each day for up to 13 additional days. Study medication will be administered in addition to standard of care deemed appropriate by the treating physician(s). Participants will be randomized to receive BGE-175 or placebo. Participants will be monitored daily for all relevant efficacy outcomes, oxygen saturation, and adverse events. Blood will be drawn periodically for safety laboratory measurements, plasma kinetics, lymphocyte subsets, C-reactive protein, and cytokines. Nasopharyngeal swabs will be collected to measure viral load. Participants will be monitored for 14 days after administration of the last dose (Day 28) and followed through Day 57.
Interventions
DRUGBGE-175
Drug
OTHERPlacebo
Placebo
Sponsors
BioAge Labs, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Intervention model description
Multicenter, Randomized, Double-blind, Placebo-controlled
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to voluntarily provide informed consent that is documented per local requirements * An understanding, ability, and willingness to fully comply with study procedures and restrictions * Hospitalized subjects with a confirmed SARS-CoV-2 infection * Laboratory (polymerase chain reaction \[PCR\]) confirmed infection with SARS-CoV-2 * Age ≥ 50 years * COVID-19 illness of any duration, and oxygen saturation measurements ≤ 94% over 5 minutes on room air (Note: low flow oxygen is permitted, but room air oxygen saturation must be ≤ 94%) * Not in respiratory failure as defined by at least one of the following: 1. Respiratory failure defined by requiring at least one of the following: * Endotracheal intubation and mechanical ventilation * Oxygen delivered by high-flow nasal cannula at flow rates \> 20 L/min with fraction of delivered oxygen ≥ 0.5) * NIPPV * ECMO * Clinical diagnosis of respiratory failure (i.e., need for one of the preceding therapies, but preceding therapies are not being administered because it is unavailable in the current setting) 2. Hemodynamic compromise (defined by systolic blood pressure \< 90 mm Hg, or diastolic blood pressure \< 60 mm Hg) or requiring vasopressors 3. Multi-organ dysfunction/failure * Females subjects of childbearing potential must have a negative pregnancy test at screening or pre-treatment on Day 1 * Male and female subjects of childbearing potential must agree to use methods of contraception that are consistent with local regulations for those participating in clinical studies
Exclusion criteria
* Participation in any other randomized, controlled clinical trial of an experimental treatment for COVID-19 (uncontrolled, compassionate use trials are allowed) * In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments * Currently participating in a vaccination trial for SARS-CoV-2 * Known positive test for influenza A or influenza B at the time of screening * Positive for human immunodeficiency virus (HIV) that is not controlled with current treatment * Hepatitis B surface antigen, or Hepatitis C positive at the time of screening. Subjects who are positive for Hepatitis C but have Hepatitis C virus (HCV) RNA below the limit of quantitation may be enrolled. Subjects with Hepatitis B, but with undetectable viral load, may be enrolled. * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 × the upper limit of normal (ULN) * Stage 4 severe chronic kidney disease (i.e., estimated glomerular filtration rate \[eGFR\] \< 30 mL/min) or acute renal failure resulting in eGFR \< 30 mL/min * Serious comorbidity, including: 1. Myocardial infarction (within the last month) 2. Moderate or severe heart failure (New York Heart Association \[NYHA\] class III or IV) 3. Acute stroke (within the last month) 4. Uncontrolled malignancy. Uncontrolled malignancy would include cancers that are not considered in remission, or solid tumor or hematological malignancies with evidence of disease progression in the past 3 months (i.e., there is evidence of disease progression by Response Evaluation Criteria in Solid Tumours \[RECIST\] or equivalent relevant criterion for the type of malignancy), and are not considered effectively managed with ongoing treatment as determined by the investigator 5. Recent severe thromboembolic disease or evidence of severe thromboembolic disease defined as a current large vessel thromboembolic event or a thromboembolic event within the past 3 months (e.g., deep vein thrombosis \[DVT\], pulmonary embolism, ischemic stroke, transient ischemic attack) requiring interventional treatment. This exclusion does not prohibit prophylaxis for thromboembolic events, including those considered possible with concurrent SARS-CoV-2 infection. * History of severe allergic or anaphylactic reactions or hypersensitivity to the study drug * Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Who Have Died or Progressed to Respiratory Failure | First dose date up to Day 28 | Proportion of participants who have died or progressed to respiratory failure as defined by progressing to the need for high-flow nasal cannula O2 delivery, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at Day 28. The proportion of participants is represented as a percentage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival | Baseline through Day 57; at Day 14, Day 28 and Day 57 | Proportion of participants surviving at Day 14, Day 28, and Day 57. The proportion of participants is represented as a percentage. |
| Proportion of Subjects Who Survive Without Progression to Respiratory Failure Through Day 28 | First dose of treatment through Day 14, Day 28 | Proportion of subjects who survive without progression to respiratory failure at Day 28. The proportion of participants is represented as a percentage. |
| Time to Two Successive Negative Viral Titers in Nasopharyngeal Swabs | Baseline through Day 28 | Kaplan-Meier Estimate of Time to Two Successive Negative Viral Titers in Nasopharyngeal Swab (median) |
| Time to Clinical Worsening From Baseline Value (Defined by Time to ≥ 1-point Worsening on WHO Ordinal Scale for COVID-19) | First dose date up to Day 57 | Kaplan-Meier Estimate of Time to Clinical Worsening from Baseline Value. Time to clinical worsening from baseline value (defined by time to ≥ 1-point worsening on World Health Organization (WHO) Ordinal Scale for COVID-19). The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death. A higher score means a worse outcome. |
| Proportion of Patients Who Develop Critical COVID-19 Illness | First dose date up to Day 57 | Proportion of patients who develop critical COVID-19 illness as defined by at least one of the following: A. RF defined based on resource utilization requiring at least one of the following: Endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \> 20 L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, ECMO, clinical diagnosis respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) B. Hemodynamic compromise (defined by systolic blood pressure \< 90 mm Hg, or diastolic blood pressure \< 60 mm Hg or requiring vasopressors) C. Multi-organ dysfunction/failure The proportion of participants is represented as a percentage. |
| Time to Clinical Improvement From Baseline Value (Defined by Time to ≥ 1-point Improvement on WHO Ordinal Scale for COVID-19 Score - Must be Maintained Through Day 28) | First dose date up to Day 28 | Kaplan-Meier Estimate of Time to Clinical Improvement from Baseline Value. Time to clinical improvement defined by time to ≥ 1-point improvement on World Health Organization (WHO) Ordinal Scale for COVID-19 - must be maintained through Day 28. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death. A higher score means a worse outcome. |
| Mean Change From Baseline in WHO Ordinal Scale for COVID-19 Score | Day 14/End of Treatment, Day 28, Day 57 | Mean change from baseline in WHO Ordinal Scale for COVID-19 score World Health Organization (WHO) Ordinal Scale for COVID-19. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death. A higher score means a worse outcome. |
| Number of Patients Who Had Intubation During the Study | First dose date up to Day 57 | Proportion of Patients who had Intubation during the study defined as proportion of patients who had any documented intubation during the study. |
| Duration of Intubation | First dose date up to Day 57 | Duration of Intubation (first post-dosing intubation) |
| Time to Discharge From Hospital Intensive Care Unit | First dose date up to Day 57 | Time from intensive care unit admission to the recorded time of intensive care unit discharge |
| Number of Patients Who Had Supplemental Oxygen Administration | First dose date up to Day 57 | Proportion of patients who had any documented post-dosing supplemental O2 administration during the study. |
| Proportion of Participants Experiencing Treatment-emergent Adverse Events | First dose of treatment through study Day 57 | Proportion of participants experiencing treatment-emergent adverse events as measured by the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0. The proportion of participants is represented as a percentage. |
| Number of Patients Who Had Noninvasive Ventilation or High-flow Nasal Cannula O2 Administration | First dose date up to Day 57 | Proportion of patients who had any documented post-dosing noninvasive ventilation or high-flow nasal cannula O2 administration. |
| Duration of Noninvasive Ventilation by Nonrebreather Mask or High-flow Nasal Cannula | First dose date up to Day 57 | Duration of participants receiving noninvasive ventilation by nonrebreather mask or high-flow nasal cannula |
| Number of Patients Who Had Mechanical Ventilation. | First dose date up to Day 57 | Proportion of patients who had any documented post-dosing mechanical ventilation. |
| Duration of Mechanical Ventilation | First dose date up to Day 57 | Duration of participants receiving mechanical ventilation |
| Number of Patients Who Had Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO. | First dose date up to Day 57 | Proportion of patients who had any documented post-dosing mechanical ventilation plus additional organ support using vasopressors, and/or renal replacement therapy and/or ECMO. |
| Duration of Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO | First dose date up to Day 57 | Duration of participants receiving mechanical ventilation plus additional organ support using vasopressors, and/or renal replacement therapy and/or ECMO |
| Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | First dose date up to Day 28 | Daily ratio of participants' oxygen saturation (SpO2) to fractional inspired O2 (SpO2/FiO2) |
| Time to Discharge From the Hospital | First dose date up to Day 57 | Length (in days) of the time of hospitalization until medical discharge |
| Number of Patients With Re-hospitalization | First dose date up to Day 57 | Proportion of patients who are hospitalized again after the discharge of first hospitalization. |
| Proportion of Participants Requiring Intensive Care Unit Admission | First dose date up to Day 57 | Proportion of participants admitted to hospital intensive care unit post randomization. The proportion of participants is represented as a percentage. |
| Duration of Supplemental Oxygen Administration | First dose date up to Day 57 | Duration of participants receiving supplemental oxygen |
Countries
Argentina, Brazil, United States
Participant flow
Recruitment details
Participants were recruited across 3 countries (US, Brazil and Argentina). Participants were hospitalized with a confirmed lab PCR SARS-COV-2 infection. First Subject First Visit was on 26 May 2021 and Last Subject Last Visit was on 19May2022.
Pre-assignment details
There were 223 participants screened for the study. Of these, 194 participants were randomized to received either asapiprant or placebo.
Participants by arm
| Arm | Count |
|---|---|
| Asapiprant (BGE-175) Participants received two 50 mg tablets of asapiprant once daily for 14 days | 96 |
| Placebo Participants received two 50 mg tablets of matching placebo tablet daily for 14 days | 98 |
| Total | 194 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 16 | 9 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Asapiprant (BGE-175) | Total | Placebo |
|---|---|---|---|
| Age, Customized Age 50 to less than 75 | 71 Participants | 142 Participants | 71 Participants |
| Age, Customized Age greater or equal to 75 | 25 Participants | 52 Participants | 27 Participants |
| Baseline WHO ordinal scale WHO ordinal scale score 3 | 12 Participants | 19 Participants | 7 Participants |
| Baseline WHO ordinal scale WHO ordinal scale score 4 | 82 Participants | 173 Participants | 91 Participants |
| Baseline WHO ordinal scale WHO ordinal scale score 5 | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 69 Participants | 137 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 54 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Black or African American | 10 Participants | 17 Participants | 7 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 8 Participants | 14 Participants | 6 Participants |
| Race/Ethnicity, Customized Race White | 78 Participants | 163 Participants | 85 Participants |
| Region of Enrollment North America | 21 Participants | 42 Participants | 21 Participants |
| Region of Enrollment South America | 75 Participants | 152 Participants | 77 Participants |
| Sex: Female, Male Female | 44 Participants | 87 Participants | 43 Participants |
| Sex: Female, Male Male | 52 Participants | 107 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 16 / 96 | 10 / 98 |
| other Total, other adverse events | 34 / 96 | 32 / 98 |
| serious Total, serious adverse events | 34 / 96 | 32 / 98 |
Outcome results
Primary
Proportion of Participants Who Have Died or Progressed to Respiratory Failure
Proportion of participants who have died or progressed to respiratory failure as defined by progressing to the need for high-flow nasal cannula O2 delivery, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at Day 28. The proportion of participants is represented as a percentage.
Time frame: First dose date up to Day 28
Population: The Intent-to-Treat (ITT) Analysis Set was used for the primary efficacy analysis and includes all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asapiprant (BGE-175) | Proportion of Participants Who Have Died or Progressed to Respiratory Failure | 31 Participants |
| Placebo | Proportion of Participants Who Have Died or Progressed to Respiratory Failure | 26 Participants |
p-value: 0.331295% CI: [0.728, 2.562]Regression, Logistic
Secondary
Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2)
Daily ratio of participants' oxygen saturation (SpO2) to fractional inspired O2 (SpO2/FiO2)
Time frame: First dose date up to Day 28
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Asapiprant (BGE-175) | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Baseline | 2.9 Ratio SpO2/FiO2 | Standard Deviation 0.71 |
| Asapiprant (BGE-175) | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 2 | 2.7 Ratio SpO2/FiO2 | Standard Deviation 0.81 |
| Asapiprant (BGE-175) | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 3 | 2.5 Ratio SpO2/FiO2 | Standard Deviation 0.92 |
| Asapiprant (BGE-175) | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 4 | 2.3 Ratio SpO2/FiO2 | Standard Deviation 0.92 |
| Asapiprant (BGE-175) | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 5 | 2.3 Ratio SpO2/FiO2 | Standard Deviation 0.91 |
| Asapiprant (BGE-175) | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 6 | 2.3 Ratio SpO2/FiO2 | Standard Deviation 0.89 |
| Asapiprant (BGE-175) | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 7 | 2.5 Ratio SpO2/FiO2 | Standard Deviation 0.99 |
| Asapiprant (BGE-175) | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 8 | 2.4 Ratio SpO2/FiO2 | Standard Deviation 0.88 |
| Asapiprant (BGE-175) | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 9 | 2.3 Ratio SpO2/FiO2 | Standard Deviation 1.02 |
| Asapiprant (BGE-175) | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 10 | 2.3 Ratio SpO2/FiO2 | Standard Deviation 1.11 |
| Asapiprant (BGE-175) | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 11 | 2.4 Ratio SpO2/FiO2 | Standard Deviation 1.1 |
| Asapiprant (BGE-175) | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 12 | 2.2 Ratio SpO2/FiO2 | Standard Deviation 0.93 |
| Asapiprant (BGE-175) | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 13 | 2.2 Ratio SpO2/FiO2 | Standard Deviation 0.71 |
| Asapiprant (BGE-175) | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 14 | 2.2 Ratio SpO2/FiO2 | Standard Deviation 0.77 |
| Asapiprant (BGE-175) | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Time of Discharge Visit | 3.1 Ratio SpO2/FiO2 | Standard Deviation 0.36 |
| Asapiprant (BGE-175) | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Follow up Day 28 | 3.2 Ratio SpO2/FiO2 | Standard Deviation 0.44 |
| Placebo | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Follow up Day 28 | 3.0 Ratio SpO2/FiO2 | Standard Deviation 0.85 |
| Placebo | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Baseline | 3.0 Ratio SpO2/FiO2 | Standard Deviation 0.63 |
| Placebo | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 9 | 2.8 Ratio SpO2/FiO2 | Standard Deviation 0.95 |
| Placebo | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 2 | 2.9 Ratio SpO2/FiO2 | Standard Deviation 0.73 |
| Placebo | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 13 | 2.8 Ratio SpO2/FiO2 | Standard Deviation 0.71 |
| Placebo | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 3 | 2.8 Ratio SpO2/FiO2 | Standard Deviation 0.75 |
| Placebo | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 10 | 2.9 Ratio SpO2/FiO2 | Standard Deviation 0.67 |
| Placebo | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 4 | 2.7 Ratio SpO2/FiO2 | Standard Deviation 0.86 |
| Placebo | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Time of Discharge Visit | 3.2 Ratio SpO2/FiO2 | Standard Deviation 0.42 |
| Placebo | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 5 | 2.6 Ratio SpO2/FiO2 | Standard Deviation 0.9 |
| Placebo | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 11 | 2.8 Ratio SpO2/FiO2 | Standard Deviation 0.64 |
| Placebo | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 6 | 2.5 Ratio SpO2/FiO2 | Standard Deviation 0.9 |
| Placebo | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 14 | 3.0 Ratio SpO2/FiO2 | Standard Deviation 0.73 |
| Placebo | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 7 | 2.6 Ratio SpO2/FiO2 | Standard Deviation 0.93 |
| Placebo | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 12 | 2.9 Ratio SpO2/FiO2 | Standard Deviation 0.72 |
| Placebo | Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) | Treatment Day 8 | 2.7 Ratio SpO2/FiO2 | Standard Deviation 0.95 |
Comparison: Baselinep-value: 0.191695% CI: [-0.35, 0.07]ANCOVA
Comparison: Treatment Day 2p-value: 0.109795% CI: [-0.44, 0.05]ANCOVA
Comparison: Treatment Day 3p-value: 0.027695% CI: [-0.63, -0.04]ANCOVA
Comparison: Treatment Day 4p-value: 0.046395% CI: [-0.71, -0.01]ANCOVA
Comparison: Treatment Day 5p-value: 0.096995% CI: [-0.71, 0.06]ANCOVA
Comparison: Treatment Day 6p-value: 0.436795% CI: [-0.57, 0.25]ANCOVA
Comparison: Treatment Day 7p-value: 0.668595% CI: [-0.54, 0.35]ANCOVA
Comparison: Treatment Day 8p-value: 0.228795% CI: [-0.73, 0.18]ANCOVA
Comparison: Treatment Day 9p-value: 0.106195% CI: [-0.96, 0.09]ANCOVA
Comparison: Treatment Day 10p-value: 0.041595% CI: [-1.06, -0.02]ANCOVA
Comparison: Treatment Day 11p-value: 0.123695% CI: [-1, 0.12]ANCOVA
Comparison: Treatment Day 12p-value: 0.009795% CI: [-1.23, -0.18]ANCOVA
Comparison: Treatment Day 13p-value: 0.015795% CI: [-1.02, -0.11]ANCOVA
Comparison: Treatment Day 14p-value: 0.00195% CI: [-1.32, -0.36]ANCOVA
Comparison: Time of Discharge Visitp-value: 0.64495% CI: [-0.4, 0.25]ANCOVA
Comparison: Follow up Day 28p-value: 0.986995% CI: [-0.6, 0.59]ANCOVA
Secondary
Duration of Intubation
Duration of Intubation (first post-dosing intubation)
Time frame: First dose date up to Day 57
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asapiprant (BGE-175) | Duration of Intubation | 11.8 Days | Standard Deviation 5.32 |
| Placebo | Duration of Intubation | 7.8 Days | Standard Deviation 7.96 |
p-value: 0.74995% CI: [-0.42, 8.08]ANCOVA
Secondary
Duration of Mechanical Ventilation
Duration of participants receiving mechanical ventilation
Time frame: First dose date up to Day 57
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asapiprant (BGE-175) | Duration of Mechanical Ventilation | 10.9 days | Standard Deviation 4.99 |
| Placebo | Duration of Mechanical Ventilation | 7.7 days | Standard Deviation 4.88 |
p-value: 0.199195% CI: [-1.86, 8.18]ANCOVA
Secondary
Duration of Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO
Duration of participants receiving mechanical ventilation plus additional organ support using vasopressors, and/or renal replacement therapy and/or ECMO
Time frame: First dose date up to Day 57
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asapiprant (BGE-175) | Duration of Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO | 8.7 days | Standard Deviation 5.85 |
| Placebo | Duration of Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO | 3 days | Standard Deviation 1.41 |
p-value: 0.129795% CI: [-1.51, 10.64]ANCOVA
Secondary
Duration of Noninvasive Ventilation by Nonrebreather Mask or High-flow Nasal Cannula
Duration of participants receiving noninvasive ventilation by nonrebreather mask or high-flow nasal cannula
Time frame: First dose date up to Day 57
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asapiprant (BGE-175) | Duration of Noninvasive Ventilation by Nonrebreather Mask or High-flow Nasal Cannula | 11.1 days | Standard Deviation 13.27 |
| Placebo | Duration of Noninvasive Ventilation by Nonrebreather Mask or High-flow Nasal Cannula | 5.4 days | Standard Deviation 7 |
p-value: 0.117295% CI: [-1.27, 11.05]ANCOVA
Secondary
Duration of Supplemental Oxygen Administration
Duration of participants receiving supplemental oxygen
Time frame: First dose date up to Day 57
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asapiprant (BGE-175) | Duration of Supplemental Oxygen Administration | 14.7 days | Standard Deviation 17 |
| Placebo | Duration of Supplemental Oxygen Administration | 11.7 days | Standard Deviation 14.81 |
p-value: 0.226595% CI: [-1.76, 7.37]ANCOVA
Secondary
Mean Change From Baseline in WHO Ordinal Scale for COVID-19 Score
Mean change from baseline in WHO Ordinal Scale for COVID-19 score World Health Organization (WHO) Ordinal Scale for COVID-19. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death. A higher score means a worse outcome.
Time frame: Day 14/End of Treatment, Day 28, Day 57
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Asapiprant (BGE-175) | Mean Change From Baseline in WHO Ordinal Scale for COVID-19 Score | Change at Day 14 | -1.2 score on a scale | Standard Deviation 2.17 |
| Asapiprant (BGE-175) | Mean Change From Baseline in WHO Ordinal Scale for COVID-19 Score | Change at Day 28 | -1.2 score on a scale | Standard Deviation 2.51 |
| Asapiprant (BGE-175) | Mean Change From Baseline in WHO Ordinal Scale for COVID-19 Score | Change at Day 57 | -2.7 score on a scale | Standard Deviation 0.58 |
| Placebo | Mean Change From Baseline in WHO Ordinal Scale for COVID-19 Score | Change at Day 14 | -1.8 score on a scale | Standard Deviation 1.76 |
| Placebo | Mean Change From Baseline in WHO Ordinal Scale for COVID-19 Score | Change at Day 28 | -1.7 score on a scale | Standard Deviation 2.11 |
| Placebo | Mean Change From Baseline in WHO Ordinal Scale for COVID-19 Score | Change at Day 57 | -2.8 score on a scale | Standard Deviation 0.42 |
p-value: 0.025495% CI: [0.08, 1.2]ANCOVA
Comparison: Change at Day 28p-value: 0.110995% CI: [-0.12, 1.18]ANCOVA
Comparison: Change at Day 57p-value: 0.86495% CI: [-0.1, 0.12]ANCOVA
Secondary
Number of Patients Who Had Intubation During the Study
Proportion of Patients who had Intubation during the study defined as proportion of patients who had any documented intubation during the study.
Time frame: First dose date up to Day 57
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asapiprant (BGE-175) | Number of Patients Who Had Intubation During the Study | 18 Participants |
| Placebo | Number of Patients Who Had Intubation During the Study | 10 Participants |
p-value: 0.091995% CI: [0.89, 4.706]Regression, Logistic
Secondary
Number of Patients Who Had Mechanical Ventilation.
Proportion of patients who had any documented post-dosing mechanical ventilation.
Time frame: First dose date up to Day 57
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.~This outcome is based on subjects who had WHO ordinal scale score of 6. A subject can have either a score of 6 or 7 (see outcome measure: Duration of Mechanical Ventilation Plus Additional Organ Support) but not both. This is the reason for the differing numbers for outcome 17 and 19.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asapiprant (BGE-175) | Number of Patients Who Had Mechanical Ventilation. | 9 Participants |
| Placebo | Number of Patients Who Had Mechanical Ventilation. | 10 Participants |
p-value: 0.85395% CI: [0.353, 2.368]Regression, Logistic
Secondary
Number of Patients Who Had Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO.
Proportion of patients who had any documented post-dosing mechanical ventilation plus additional organ support using vasopressors, and/or renal replacement therapy and/or ECMO.
Time frame: First dose date up to Day 57
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.~This outcome is based on subjects who had WHO ordinal scale score of 7. A subject can have either a score of 6 (see outcome measure: Duration of Mechanical Ventilation) or 7 but not both. This is the reason for the differing numbers for outcome 17 and 19.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asapiprant (BGE-175) | Number of Patients Who Had Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO. | 14 Participants |
| Placebo | Number of Patients Who Had Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO. | 4 Participants |
p-value: 0.016695% CI: [1.293, 13.027]Regression, Logistic
Secondary
Number of Patients Who Had Noninvasive Ventilation or High-flow Nasal Cannula O2 Administration
Proportion of patients who had any documented post-dosing noninvasive ventilation or high-flow nasal cannula O2 administration.
Time frame: First dose date up to Day 57
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asapiprant (BGE-175) | Number of Patients Who Had Noninvasive Ventilation or High-flow Nasal Cannula O2 Administration | 26 Participants |
| Placebo | Number of Patients Who Had Noninvasive Ventilation or High-flow Nasal Cannula O2 Administration | 23 Participants |
p-value: 0.549795% CI: [0.633, 2.364]Regression, Logistic
Secondary
Number of Patients Who Had Supplemental Oxygen Administration
Proportion of patients who had any documented post-dosing supplemental O2 administration during the study.
Time frame: First dose date up to Day 57
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asapiprant (BGE-175) | Number of Patients Who Had Supplemental Oxygen Administration | 86 Participants |
| Placebo | Number of Patients Who Had Supplemental Oxygen Administration | 92 Participants |
p-value: 0.262195% CI: [0.184, 1.586]Regression, Logistic
Secondary
Number of Patients With Re-hospitalization
Proportion of patients who are hospitalized again after the discharge of first hospitalization.
Time frame: First dose date up to Day 57
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asapiprant (BGE-175) | Number of Patients With Re-hospitalization | 6 Participants |
| Placebo | Number of Patients With Re-hospitalization | 7 Participants |
p-value: 0.808195% CI: [0.28, 2.695]Regression, Logistic
Secondary
Proportion of Participants Experiencing Treatment-emergent Adverse Events
Proportion of participants experiencing treatment-emergent adverse events as measured by the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0. The proportion of participants is represented as a percentage.
Time frame: First dose of treatment through study Day 57
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asapiprant (BGE-175) | Proportion of Participants Experiencing Treatment-emergent Adverse Events | 73 Participants |
| Placebo | Proportion of Participants Experiencing Treatment-emergent Adverse Events | 71 Participants |
Secondary
Proportion of Participants Requiring Intensive Care Unit Admission
Proportion of participants admitted to hospital intensive care unit post randomization. The proportion of participants is represented as a percentage.
Time frame: First dose date up to Day 57
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asapiprant (BGE-175) | Proportion of Participants Requiring Intensive Care Unit Admission | 22 Participants |
| Placebo | Proportion of Participants Requiring Intensive Care Unit Admission | 17 Participants |
p-value: 0.319395% CI: [0.704, 2.929]Regression, Logistic
Secondary
Proportion of Patients Who Develop Critical COVID-19 Illness
Proportion of patients who develop critical COVID-19 illness as defined by at least one of the following: A. RF defined based on resource utilization requiring at least one of the following: Endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \> 20 L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, ECMO, clinical diagnosis respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) B. Hemodynamic compromise (defined by systolic blood pressure \< 90 mm Hg, or diastolic blood pressure \< 60 mm Hg or requiring vasopressors) C. Multi-organ dysfunction/failure The proportion of participants is represented as a percentage.
Time frame: First dose date up to Day 57
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Asapiprant (BGE-175) | Proportion of Patients Who Develop Critical COVID-19 Illness | 34 Participants |
| Placebo | Proportion of Patients Who Develop Critical COVID-19 Illness | 28 Participants |
p-value: 0.294195% CI: [0.752, 2.561]Regression, Logistic
Secondary
Proportion of Subjects Who Survive Without Progression to Respiratory Failure Through Day 28
Proportion of subjects who survive without progression to respiratory failure at Day 28. The proportion of participants is represented as a percentage.
Time frame: First dose of treatment through Day 14, Day 28
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Asapiprant (BGE-175) | Proportion of Subjects Who Survive Without Progression to Respiratory Failure Through Day 28 | Day 14 | 69.5 percentage of participants |
| Asapiprant (BGE-175) | Proportion of Subjects Who Survive Without Progression to Respiratory Failure Through Day 28 | Day 28 | 67.3 percentage of participants |
| Placebo | Proportion of Subjects Who Survive Without Progression to Respiratory Failure Through Day 28 | Day 14 | 78.6 percentage of participants |
| Placebo | Proportion of Subjects Who Survive Without Progression to Respiratory Failure Through Day 28 | Day 28 | 73.4 percentage of participants |
Comparison: Statistical analysis was only performed for Day 28. This is timeframe used for the primary endpointp-value: 0.2687Log Rank
Secondary
Survival
Proportion of participants surviving at Day 14, Day 28, and Day 57. The proportion of participants is represented as a percentage.
Time frame: Baseline through Day 57; at Day 14, Day 28 and Day 57
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. Subjects who discontinued the study prior to the timepoint are censored at the date of discontinuation and excluded from the analysis. At Day 57, the number participants analyzed were different because 9 participants were censored from the asapiprant arm and 15 participants from the placebo arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Asapiprant (BGE-175) | Survival | Survival at Day 14 | 89 Participants |
| Asapiprant (BGE-175) | Survival | Survival at Day 28 | 79 Participants |
| Asapiprant (BGE-175) | Survival | Survival at Day 57 | 69 Participants |
| Placebo | Survival | Survival at Day 14 | 93 Participants |
| Placebo | Survival | Survival at Day 28 | 87 Participants |
| Placebo | Survival | Survival at Day 57 | 72 Participants |
Comparison: Day 14p-value: 0.456195% CI: [0.133, 2.475]Regression, Logistic
Comparison: Day 28p-value: 0.155995% CI: [0.212, 1.282]Regression, Logistic
Comparison: Day 57p-value: 0.129395% CI: [0.203, 1.226]Regression, Logistic
Secondary
Time to Clinical Improvement From Baseline Value (Defined by Time to ≥ 1-point Improvement on WHO Ordinal Scale for COVID-19 Score - Must be Maintained Through Day 28)
Kaplan-Meier Estimate of Time to Clinical Improvement from Baseline Value. Time to clinical improvement defined by time to ≥ 1-point improvement on World Health Organization (WHO) Ordinal Scale for COVID-19 - must be maintained through Day 28. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death. A higher score means a worse outcome.
Time frame: First dose date up to Day 28
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Asapiprant (BGE-175) | Time to Clinical Improvement From Baseline Value (Defined by Time to ≥ 1-point Improvement on WHO Ordinal Scale for COVID-19 Score - Must be Maintained Through Day 28) | 8 days |
| Placebo | Time to Clinical Improvement From Baseline Value (Defined by Time to ≥ 1-point Improvement on WHO Ordinal Scale for COVID-19 Score - Must be Maintained Through Day 28) | 6 days |
p-value: 0.3325Log Rank
Secondary
Time to Clinical Worsening From Baseline Value (Defined by Time to ≥ 1-point Worsening on WHO Ordinal Scale for COVID-19)
Kaplan-Meier Estimate of Time to Clinical Worsening from Baseline Value. Time to clinical worsening from baseline value (defined by time to ≥ 1-point worsening on World Health Organization (WHO) Ordinal Scale for COVID-19). The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death. A higher score means a worse outcome.
Time frame: First dose date up to Day 57
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Asapiprant (BGE-175) | Time to Clinical Worsening From Baseline Value (Defined by Time to ≥ 1-point Worsening on WHO Ordinal Scale for COVID-19) | NA days |
| Placebo | Time to Clinical Worsening From Baseline Value (Defined by Time to ≥ 1-point Worsening on WHO Ordinal Scale for COVID-19) | NA days |
p-value: 0.2229Log Rank
Secondary
Time to Discharge From Hospital Intensive Care Unit
Time from intensive care unit admission to the recorded time of intensive care unit discharge
Time frame: First dose date up to Day 57
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asapiprant (BGE-175) | Time to Discharge From Hospital Intensive Care Unit | 15.7 days | Standard Deviation 7.67 |
| Placebo | Time to Discharge From Hospital Intensive Care Unit | 12.1 days | Standard Deviation 8.55 |
p-value: 0.176995% CI: [-1.75, 9.13]ANCOVA
Secondary
Time to Discharge From the Hospital
Length (in days) of the time of hospitalization until medical discharge
Time frame: First dose date up to Day 57
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asapiprant (BGE-175) | Time to Discharge From the Hospital | 10.8 days | Standard Deviation 10.73 |
| Placebo | Time to Discharge From the Hospital | 9.1 days | Standard Deviation 9.09 |
p-value: 0.239995% CI: [-1.14, 4.52]ANCOVA
Secondary
Time to Two Successive Negative Viral Titers in Nasopharyngeal Swabs
Kaplan-Meier Estimate of Time to Two Successive Negative Viral Titers in Nasopharyngeal Swab (median)
Time frame: Baseline through Day 28
Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Asapiprant (BGE-175) | Time to Two Successive Negative Viral Titers in Nasopharyngeal Swabs | 29 days |
| Placebo | Time to Two Successive Negative Viral Titers in Nasopharyngeal Swabs | 29 days |
p-value: 0.3977Log Rank