Acute Respiratory Distress Syndrome (ARDS), COVID-19
Conditions
Keywords
COVID-19, ARDS, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Brief summary
This was a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter, dose escalation and proof-of-concept study to evaluate the safety and efficacy of razuprotafib, administered 3 times daily (TID) (every 8 hours \[Q8H\]), in hospitalized subjects with moderate to severe Coronavirus disease 2019 (COVID-19) receiving standard of care therapy. The study was planned to include 2 parts with Part 1 comprising the dose escalation period of the study and Part 2 comprising the proof-of-concept safety and efficacy period of the study.
Detailed description
Part 1 was to be a 2-step dose escalation that included approximately 60 subjects. Part 1, Step 1 was to include 30 subjects, and Part 1, Step 2 was to include 30 subjects. Part 1 was designed to primarily focus on safety; however, efficacy data was to be collected and analyzed as well. Despite the Data Review Committee (DRC) recommendation to continue the study, after completion of Part 1, Step 1, the Sponsor elected to discontinue the study due to business-related reasons. Recruitment challenges and slow site startup led to delays in completing the study in a practical timeframe, and were the primary reasons to discontinue the study. No further subjects were recruited after Part 1, Step 1 completion. A full analysis of the data from Part 1, Step 1 was conducted and is presented in this report. Part 1, Step 2 and Part 2 was not conducted.
Interventions
DRUGRazuprotafib Subcutaneous Solution
Up to 3 daily dose levels of Razuprotafib Subcutaneous Solution will be evaluated. Doses will be administered subcutaneously three times daily (Q8H) for 7 days.
DRUGPlacebo Subcutaneous Solution
Matched vehicle-controlled placebo solution will be administered subcutaneously three times daily (Q8H) for 7 days
Sponsors
EyePoint Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
The study was planned to include 2 parts with Part 1 comprising the dose escalation period of the study and Part 2 comprising the proof-of-concept safety and efficacy period of the study. Although The Data Review Committee (DRC) recommended to continue with the study after the completion of Part 1, Step 1, the Sponsor elected to discontinue the study due to business-related reasons.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ability to understand and provide informed consent; 2. Males and non-pregnant females 18 years of age or older at the time of Screening; 3. Laboratory-confirmed active SARS-CoV-2 infection within 72 hours prior to randomization, or (if testing results cannot be obtained) by evidence of progressive disease suggestive of ongoing SARS-CoV-2 infection; 4. Females of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception through Day 28; and have a negative urine pregnancy test during Screening; 5. Currently hospitalized, receiving standard of care therapy for COVID-19, and meets the criteria for moderate or severe COVID-19, as follows: Moderate = symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion and with respiratory rate at 20 or greater breaths/min, Peripheral capillary oxygen saturation (SpO2) \>93% on room air at sea level, or heart rate at 90 or greater beats/min; Severe = symptoms suggestive of severe systemic illness with COVID-19, which could include any symptom of moderate illness, shortness of breath at rest, or respiratory distress, and respiratory rate at 30 or greater breaths/min, heart rate at 125 or greater beats/min, or SpO2 \>93% on room air at sea level or (partial pressure of oxygen:fraction of inspired oxygen (PaO2:FiO2) \<300.
Exclusion criteria
1. Inability to initiate study drug within 12 hours after randomization; 2. Female of childbearing potential who is unable or unwilling to forego breastfeeding through Day 28; 3. Systolic blood pressure \<100 mmHg; 4. In shock or requiring pressor support; 5. Respiratory failure, defined as subjects who are on mechanical ventilation; are receiving 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 of 0.5 or greater), noninvasive positive pressure ventilation, or extracorporeal membrane oxygenation (ECMO); or have a clinical diagnosis of respiratory failure (ie, clinical need for 1 of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation); 6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 × the upper limit of normal (ULN); 7. Total bilirubin \>2 × ULN; 8. Estimated glomerular filtration rate \<30 mL/min or receiving hemodialysis or hemofiltration; 9. Moribund subject not expected to survive 24 hours in the opinion of the treating clinical team; 10. Any concurrent serious medical condition (eg, active malignancies on chemotherapy, post organ transplant, end stage congestive heart failure) or not likely to respond to treatment; 11. Decision to withhold life-sustaining treatment; Note: In the event of cardiac arrest, the decision to withhold cardiopulmonary resuscitation only does not fulfill this exclusion criterion. 12. Use of cytochrome P450 (CYP) 2 subfamily C, polypeptide 8 (2C8) substrates (eg, repaglinide, paclitaxel, or cerivastatin) or CYP3A4 substrates (eg, amlodipine, budesonide, dasabuvir, enzalutamide, imatinib, lopinavir, loperamide, saquinavir, sildenafil, midazolam, or montelukast); 13. Use of CYP2C8 inhibitors (eg, gemfibrozil, fluvoxamine, or ketoconazole); 14. Participation in another investigational study during the present study through the last visit (Day 28); or 15. Previous randomization in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percent of Subjects Who Were Alive and Free of Respiratory Failure Prior to Day 7 and Day 28 | Baseline up to Day 7 and Day 28 | All results were summarized descriptively by treatment arm and expressed as proportions, along with corresponding 95%CI of the difference between response rates, and p-values using Cochran-Mantel-Haenszel (CMH). The 95% CI will be constructed using the normal approximation method. Respiratory failure was defined as subjects who were on invasive mechanical ventilation; received oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20L/min with fraction of delivered oxygen ≥0.5) noninvasive positive pressure ventilation or extracorporeal membrane oxygenation; or had a clinical diagnosis of respiratory failure (ie, clinical need for 1 of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation).Subjects who died prior to the study timepoint (Day 7 or Day 28) were imputed based on the worst outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Summary of The Mean Change From Baseline in D-Dimer at Day 7 and 28 | at Day 7 and 28 | Mean Change from baseline in systemic biomarkers of vascular leakage and inflammation (ie, D-Dimer) at Day 7 and 28 in the Full Analysis Set |
| Summary of Change From Baseline in C-Reactive Protein (CRP) at Day 7 and 28 | at Day 7 and 28 | Change from baseline in systemic biomarkers of vascular leakage and inflammation (ie, CRP ) at Day 7 and 28 in the Full Analysis Set |
| Number of Participants Who Improve by at Least 2 Categories on the NIAID 8-point Ordinal Scale From Baseline to Day 7 and Baseline to Day 28 | from baseline to Day 7 and baseline to Day 28 | Analysis of the proportion of participants who improve by \>=2 categories on the NIAID 8-point scale from baseline to Day 7. % = 100 x n/N', where N' = number of participants with a non-missing values at baseline and the specified post-baseline visit. Baseline is defined as the last measurement prior to the first dose of study drug. |
| Number of Participants Who Were Discharged and Free of Respiratory Failure Prior to Day 7 and Day 28 | Day 7 and Day 28 | The number of participants who were discharged and free of respiratory failure at Day 7 and Day 28 were summarized by treatment arm and pooled razuprotafib (10 and 20 mg) group. |
| Number of Participants Alive and Not Requiring Invasive Mechanical Ventilation at Any Time | Baseline up to Day 28 | Analysis of Number of Participants Alive and Not Requiring Invasive Mechanical Ventilation at Any Time Through Day 28 in the Full Analysis Set |
| Time to Reach Grade 6, 7, or 8 on the NIAID 8-Point Ordinal Scale | From Screening through the end of the study (up to 28 days) | The clinical status of the participants was assessed within 1 hr prior to each dose of study drug, using the NIAID 8-point ordinal scale until Day 28. After the treatment period, clinical status will be assessed once daily until Day 18, unless discharged. If the subject is discharged alive prior to Day 28, clinical status was assessed at the post-treatment observation period telephone visits only. Grade 6=hospitalized, not requiring oxygen and no longer requires ongoing medical care; Grade 7 = not hospitalized, limitation on activities and/or requiring home oxygen; and Grade 8 = not hospitalized, no limitations on activities. |
| Change in PaO2:FiO2 Ratio From Baseline to Day 7 and Baseline to Day 28 | Baseline up to Day 7 and Day 28 | Analysis of the change in PaO2:FiO2 ratio from baseline to Day 7 (or discharge) and baseline to Day 28 (or discharge) in the intent-to-treat population. Baseline was defined as the last measurement prior to the first dose of study drug. Baseline PaO2;FiO2 ratio value was not provided for the pooled Razuprotafib group. |
| Length of Hospitalization From Baseline to Day 7 and Day 28 (or Death) | From Baseline to Day 7 or Day 28 (or Death) | Analysis of length of hospitalization from baseline to day 7 and day 28 (or death) in the intent-to-treat population. Baseline was defined as the last measurement prior to the first dose of study drug. Baseline values were not provided. The length of hospitalization was to include all days that the participant was admitted to the hospital. For participants who were discharged and readmitted to the hospital, the length of hospitalization was to include the days after readmission. Hospitalization days were counted in 24-hour periods; any partial days were counted as a whole day. |
| Number of Participants Who Worsen by Greater Than or Equal to 2 Categories on The NIAID 8-point Ordinal Scale From Baseline to Day 7 and Day 28 | From baseline to Day 7 and Day 28 | Analysis of number of participants who worsen by \>= 2 categories on the NIAID 8-point ordinal scale from baseline to Day 7 in the Full Analysis Population. % = 100 x n/N', where N' = number of participants with non-missing values at baseline and the specified post-baseline visit. Participants who died prior to the Day 7 or Day 28 were imputed as 1. |
| Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline, Day 7, and Day 28 | Summary of number and percent of subjects in each category (ie, categories 1 to 8) of the NIAID 8-Point Ordinal Scale at baseline, Day 7 and Day 28. The NIAID 8-point ordinal scale includes the following grades: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplementation oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized, limitation on activities and/or requiring home oxygen; and 8. Not hospitalized, no limitations on activities. |
| The Number and Percent of Participants Who Experienced All-Cause Mortality at Day 7 and Day 28 | Baseline up to Day 7 and Day 28 | Analysis of the Number and Percent of Participants who Experienced All-Cause Mortality at Day 7 and Day 28 in the Full Analysis Set |
| Number of Participants Who Improve by Greater or Equal to 2 Categories on the NIAID 8-point Ordinal Scale From Baseline to Day 7 and Day 28 | Baseline to Day 7 and Day 28 | Analysis of number of participants who improve by \>= 2 categories on the NIAID 8-point scale from baseline to Day 7 and Day 28 in the full analysis set.% = 100 x n/N', where N' = number of participants with non-missing values at baseline and the specified post-baseline visit. Participants who died prior to the Day 7 or Day 28 were imputed as 1. |
| Time to Return to Prehospitalization Oxygen Requirement | up to 28 days | Summary of Time to Return to Prehospitalization Oxygen Requirement in the Intent-to-Treat Population |
| Length of Hospitalization and Not Requiring Invasive Mechanical Ventilation From Baseline to Day 7 and Day 28 (or Death) | Baseline up to Day 7 and Day 28 | Analysis of length of hospitalization and not requiring invasive mechanical ventilation from baseline to Day 7 and Day 28 in the intent-to-treat population. Note: The overall number of participants analyzed represents the total number of participants in each treatment group for the ITT Population. The summaries of the mean number of days from baseline included only those participants with available data. Baseline was defined as the last measurement prior to the first dose of study drug. Baseline values were not provided.The length of hospitalization was to include all days that the participant was admitted to the hospital. For participants who were discharged and readmitted to the hospital, the length of hospitalization was to include the days after readmission. Hospitalization days were counted in 24-hour periods; any partial days were counted as a whole day. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Summary of Razuprotafib Plasma Concentration | razuprotafib plasma concentrations 30 and 90 minutes post-dose on Days 1 and 6 | A summary of plasma razuprotafib concentrations for samples collected on Day 1 and 6 in the pharmacokinetic population. All results were summarized descriptively by treatment group. |
Countries
United States
Participant flow
Recruitment details
A total of 31 subjects (11 in the placebo, 10 in the 10 mg Razuprotafib, and 10 in the 20 mg razuprotafib groups) were enrolled from a period October 21, 2020 to February 26, 2021. A total of 29 subjects (10 in the placebo, 9 in the 10 mg Razuprotafib, and 10 in the razuprotafib groups) were treated with study treatment. Two subjects (1 in each of placebo and 10 mg razuprotafib groups) were randomized and not treated. Therefore, a total of 29 subjects are included in the safety population.
Participants by arm
| Arm | Count |
|---|---|
| Razuprotafib 10mg Razuprotafib Subcutaneous Solution: Up to 3 daily dose levels of Razuprotafib Subcutaneous Solution will be evaluated. Doses will be administered subcutaneously three times daily (Q8H) for 7 days. | 10 |
| Razuprotafib 20mg Razuprotafib Subcutaneous Solution: Up to 3 daily dose levels of Razuprotafib Subcutaneous Solution will be evaluated. Doses will be administered subcutaneously three times daily (Q8H) for 7 days. | 10 |
| Placebo Placebo Subcutaneous Solution: Matched vehicle-controlled placebo solution will be administered subcutaneously three times daily (Q8H) for 7 days | 11 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | reason not provided | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Razuprotafib 20mg | Total | Razuprotafib 10mg | Placebo |
|---|---|---|---|---|
| Age, Customized Age at Informed Consent | 53.4 years STANDARD_DEVIATION 16.55 | 58.3 years STANDARD_DEVIATION 14.85 | 58.3 years STANDARD_DEVIATION 11.52 | 62.7 years STANDARD_DEVIATION 15.81 |
| Comorbid conditions, n (%) Chronic Kidney Disease | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Comorbid conditions, n (%) Diabetes | 4 Participants | 13 Participants | 3 Participants | 6 Participants |
| Comorbid conditions, n (%) Heart Failure | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Comorbid conditions, n (%) Hypertension | 6 Participants | 19 Participants | 8 Participants | 5 Participants |
| Comorbid conditions, n (%) Obesity | 4 Participants | 10 Participants | 4 Participants | 2 Participants |
| Concomitant medications to treat COVID-19 at baseline, n (%) None | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Concomitant medications to treat COVID-19 at baseline, n (%) Other | 8 Participants | 18 Participants | 6 Participants | 4 Participants |
| Concomitant medications to treat COVID-19 at baseline, n (%) Remdesivir | 6 Participants | 17 Participants | 3 Participants | 8 Participants |
| Concomitant medications to treat COVID-19 at baseline, n (%) Systemic steroids | 10 Participants | 28 Participants | 8 Participants | 10 Participants |
| Coronavirus disease (COVID-19) severity, n (%) Moderate | 2 Participants | 8 Participants | 3 Participants | 3 Participants |
| Coronavirus disease (COVID-19) severity, n (%) Severe | 8 Participants | 23 Participants | 7 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 7 Participants | 4 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 23 Participants | 5 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| National Institutes of Allergy and Infectious Diseases Category 1 = Death | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| National Institutes of Allergy and Infectious Diseases Category 2 = Hospitalized on mechanical ventilation | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| National Institutes of Allergy and Infectious Diseases Category 3 = Hospitalized, on noninvasive ventilation or high-flow oxygen devices | 5 Participants | 13 Participants | 4 Participants | 4 Participants |
| National Institutes of Allergy and Infectious Diseases Category 4= Hospitalized, requiring supplemental oxygen | 5 Participants | 16 Participants | 5 Participants | 6 Participants |
| National Institutes of Allergy and Infectious Diseases Category 5= Hospitalized, not requiring supplemental oxygen - requiring ongoing COVID-19 care | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| National Institutes of Allergy and Infectious Diseases Category 6= Hospitalized, not requiring supplemental oxygen - no longer requires medical care | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| National Institutes of Allergy and Infectious Diseases Category 7=Not hospitalized, limitation on activities or requiring home oxygen | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| National Institutes of Allergy and Infectious Diseases Category 8= Not hospitalized, no limitations on activities | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Pre-hospitalization oxygen requirement, n (%) CPAP mask (for non-respiratory failure reasons) | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Pre-hospitalization oxygen requirement, n (%) Low-flow nasal cannula | 0 Participants | 3 Participants | 2 Participants | 1 Participants |
| Pre-hospitalization oxygen requirement, n (%) None | 10 Participants | 27 Participants | 7 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 6 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 19 Participants | 4 Participants | 8 Participants |
| Screening Peripheral Oxygen Saturation (Pa02)/Fraction of Inspired Oxygen (FiO2) ratio | 146.15 ratio STANDARD_DEVIATION 80.602 | 186.71 ratio STANDARD_DEVIATION 118.212 | 194.97 ratio STANDARD_DEVIATION 131.546 | 212.40 ratio STANDARD_DEVIATION 132.21 |
| Sex: Female, Male Female | 2 Participants | 8 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 8 Participants | 23 Participants | 9 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 10 | 1 / 9 | 1 / 10 |
| other Total, other adverse events | 6 / 10 | 7 / 9 | 8 / 10 |
| serious Total, serious adverse events | 2 / 10 | 2 / 9 | 5 / 10 |
Outcome results
Primary
Number and Percent of Subjects Who Were Alive and Free of Respiratory Failure Prior to Day 7 and Day 28
All results were summarized descriptively by treatment arm and expressed as proportions, along with corresponding 95%CI of the difference between response rates, and p-values using Cochran-Mantel-Haenszel (CMH). The 95% CI will be constructed using the normal approximation method. Respiratory failure was defined as subjects who were on invasive mechanical ventilation; received oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20L/min with fraction of delivered oxygen ≥0.5) noninvasive positive pressure ventilation or extracorporeal membrane oxygenation; or had a clinical diagnosis of respiratory failure (ie, clinical need for 1 of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation).Subjects who died prior to the study timepoint (Day 7 or Day 28) were imputed based on the worst outcome.
Time frame: Baseline up to Day 7 and Day 28
Population: The Full Analysis (FA) Population included subjects who received at least 1 dose of study drug and had at least 1 post-dose efficacy evaluation. The FA Population was a subset of the ITT Population which was defined as all subjects randomized. Note: The overall number of participants analyzed represents the total number of participants in each treatment group for the FA Population. Count of participants who were alive and free of respiratory failure on Days 7 and 28 were included in analyses.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number and Percent of Subjects Who Were Alive and Free of Respiratory Failure Prior to Day 7 and Day 28 | Number and Percent of Subjects who were Alive and Free of Respiratory Failure Prior to Day 28 | 9 Participants |
| Placebo | Number and Percent of Subjects Who Were Alive and Free of Respiratory Failure Prior to Day 7 and Day 28 | Number and Percent of Subjects who were Alive and Free of Respiratory Failure Prior to Day 7 | 8 Participants |
| Razuprotafib 10 mg | Number and Percent of Subjects Who Were Alive and Free of Respiratory Failure Prior to Day 7 and Day 28 | Number and Percent of Subjects who were Alive and Free of Respiratory Failure Prior to Day 7 | 5 Participants |
| Razuprotafib 10 mg | Number and Percent of Subjects Who Were Alive and Free of Respiratory Failure Prior to Day 7 and Day 28 | Number and Percent of Subjects who were Alive and Free of Respiratory Failure Prior to Day 28 | 6 Participants |
| Razuprotafib 20 mg | Number and Percent of Subjects Who Were Alive and Free of Respiratory Failure Prior to Day 7 and Day 28 | Number and Percent of Subjects who were Alive and Free of Respiratory Failure Prior to Day 7 | 6 Participants |
| Razuprotafib 20 mg | Number and Percent of Subjects Who Were Alive and Free of Respiratory Failure Prior to Day 7 and Day 28 | Number and Percent of Subjects who were Alive and Free of Respiratory Failure Prior to Day 28 | 7 Participants |
| Pooled Razuprotafib | Number and Percent of Subjects Who Were Alive and Free of Respiratory Failure Prior to Day 7 and Day 28 | Number and Percent of Subjects who were Alive and Free of Respiratory Failure Prior to Day 28 | 13 Participants |
| Pooled Razuprotafib | Number and Percent of Subjects Who Were Alive and Free of Respiratory Failure Prior to Day 7 and Day 28 | Number and Percent of Subjects who were Alive and Free of Respiratory Failure Prior to Day 7 | 11 Participants |
Secondary
Change in PaO2:FiO2 Ratio From Baseline to Day 7 and Baseline to Day 28
Analysis of the change in PaO2:FiO2 ratio from baseline to Day 7 (or discharge) and baseline to Day 28 (or discharge) in the intent-to-treat population. Baseline was defined as the last measurement prior to the first dose of study drug. Baseline PaO2;FiO2 ratio value was not provided for the pooled Razuprotafib group.
Time frame: Baseline up to Day 7 and Day 28
Population: Intent-to-Treat (ITT) Population: The ITT Population was defined as all subjects randomized. Participants in this population were analyzed according to the treatment group to which they were assigned at randomization. Note: The overall number of participants analyzed represents the total number of participants in each treatment group for the ITT Population. The summaries of the mean changes from baseline included only those participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in PaO2:FiO2 Ratio From Baseline to Day 7 and Baseline to Day 28 | Day 28 | 140.95 ratio | Standard Deviation 76.887 |
| Placebo | Change in PaO2:FiO2 Ratio From Baseline to Day 7 and Baseline to Day 28 | Day 7 | 27.44 ratio | Standard Deviation 55.259 |
| Placebo | Change in PaO2:FiO2 Ratio From Baseline to Day 7 and Baseline to Day 28 | Baseline | 212.40 ratio | Standard Deviation 132.21 |
| Razuprotafib 10 mg | Change in PaO2:FiO2 Ratio From Baseline to Day 7 and Baseline to Day 28 | Day 28 | 96.21 ratio | Standard Deviation 155.077 |
| Razuprotafib 10 mg | Change in PaO2:FiO2 Ratio From Baseline to Day 7 and Baseline to Day 28 | Baseline | 194.97 ratio | Standard Deviation 131.546 |
| Razuprotafib 10 mg | Change in PaO2:FiO2 Ratio From Baseline to Day 7 and Baseline to Day 28 | Day 7 | 18.81 ratio | Standard Deviation 82.833 |
| Razuprotafib 20 mg | Change in PaO2:FiO2 Ratio From Baseline to Day 7 and Baseline to Day 28 | Baseline | 146.15 ratio | Standard Deviation 80.602 |
| Razuprotafib 20 mg | Change in PaO2:FiO2 Ratio From Baseline to Day 7 and Baseline to Day 28 | Day 7 | 48.34 ratio | Standard Deviation 81.008 |
| Razuprotafib 20 mg | Change in PaO2:FiO2 Ratio From Baseline to Day 7 and Baseline to Day 28 | Day 28 | 117.01 ratio | Standard Deviation 87.03 |
| Pooled Razuprotafib | Change in PaO2:FiO2 Ratio From Baseline to Day 7 and Baseline to Day 28 | Day 28 | 110.08 ratio | Standard Deviation 97.312 |
| Pooled Razuprotafib | Change in PaO2:FiO2 Ratio From Baseline to Day 7 and Baseline to Day 28 | Day 7 | 34.92 ratio | Standard Deviation 79.142 |
Secondary
Length of Hospitalization and Not Requiring Invasive Mechanical Ventilation From Baseline to Day 7 and Day 28 (or Death)
Analysis of length of hospitalization and not requiring invasive mechanical ventilation from baseline to Day 7 and Day 28 in the intent-to-treat population. Note: The overall number of participants analyzed represents the total number of participants in each treatment group for the ITT Population. The summaries of the mean number of days from baseline included only those participants with available data. Baseline was defined as the last measurement prior to the first dose of study drug. Baseline values were not provided.The length of hospitalization was to include all days that the participant was admitted to the hospital. For participants who were discharged and readmitted to the hospital, the length of hospitalization was to include the days after readmission. Hospitalization days were counted in 24-hour periods; any partial days were counted as a whole day.
Time frame: Baseline up to Day 7 and Day 28
Population: Intent-to-Treat (ITT) Population: The ITT Population was defined as all subjects randomized. Participants in this population were analyzed according to the treatment group to which they were assigned at randomization. Note: The overall number of participants analyzed represents the total number of participants in each treatment group for the ITT Population. Those participants who had post-baseline values on Day 7 and 28 were included in the analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Length of Hospitalization and Not Requiring Invasive Mechanical Ventilation From Baseline to Day 7 and Day 28 (or Death) | Day 7 | 5.0 Days | Standard Deviation 1.7 |
| Placebo | Length of Hospitalization and Not Requiring Invasive Mechanical Ventilation From Baseline to Day 7 and Day 28 (or Death) | Day 28 | 7.2 Days | Standard Deviation 4.69 |
| Razuprotafib 10 mg | Length of Hospitalization and Not Requiring Invasive Mechanical Ventilation From Baseline to Day 7 and Day 28 (or Death) | Day 28 | 9.9 Days | Standard Deviation 6.64 |
| Razuprotafib 10 mg | Length of Hospitalization and Not Requiring Invasive Mechanical Ventilation From Baseline to Day 7 and Day 28 (or Death) | Day 7 | 5.8 Days | Standard Deviation 2.17 |
| Razuprotafib 20 mg | Length of Hospitalization and Not Requiring Invasive Mechanical Ventilation From Baseline to Day 7 and Day 28 (or Death) | Day 7 | 6.2 Days | Standard Deviation 1.14 |
| Razuprotafib 20 mg | Length of Hospitalization and Not Requiring Invasive Mechanical Ventilation From Baseline to Day 7 and Day 28 (or Death) | Day 28 | 12.7 Days | Standard Deviation 8.31 |
| Pooled Razuprotafib | Length of Hospitalization and Not Requiring Invasive Mechanical Ventilation From Baseline to Day 7 and Day 28 (or Death) | Day 7 | 6.0 Days | Standard Deviation 1.67 |
| Pooled Razuprotafib | Length of Hospitalization and Not Requiring Invasive Mechanical Ventilation From Baseline to Day 7 and Day 28 (or Death) | Day 28 | 11.4 Days | Standard Deviation 7.54 |
Secondary
Length of Hospitalization From Baseline to Day 7 and Day 28 (or Death)
Analysis of length of hospitalization from baseline to day 7 and day 28 (or death) in the intent-to-treat population. Baseline was defined as the last measurement prior to the first dose of study drug. Baseline values were not provided. The length of hospitalization was to include all days that the participant was admitted to the hospital. For participants who were discharged and readmitted to the hospital, the length of hospitalization was to include the days after readmission. Hospitalization days were counted in 24-hour periods; any partial days were counted as a whole day.
Time frame: From Baseline to Day 7 or Day 28 (or Death)
Population: Intent-to-Treat (ITT) Population: The ITT Population was defined as all subjects randomized. Participants in this population were analyzed according to the treatment group to which they were assigned at randomization. Note: The overall number of participants analyzed represents the total number of participants in each treatment group for the ITT Population. Participants who had post-baseline data on Days 7 and 28 (or death) were included in the analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Length of Hospitalization From Baseline to Day 7 and Day 28 (or Death) | Day 7 | 5.0 Days | Standard Deviation 1.7 |
| Placebo | Length of Hospitalization From Baseline to Day 7 and Day 28 (or Death) | Day 28 | 7.2 Days | Standard Deviation 4.69 |
| Razuprotafib 10 mg | Length of Hospitalization From Baseline to Day 7 and Day 28 (or Death) | Day 28 | 14.1 Days | Standard Deviation 9.69 |
| Razuprotafib 10 mg | Length of Hospitalization From Baseline to Day 7 and Day 28 (or Death) | Day 7 | 5.8 Days | Standard Deviation 2.17 |
| Razuprotafib 20 mg | Length of Hospitalization From Baseline to Day 7 and Day 28 (or Death) | Day 7 | 6.2 Days | Standard Deviation 1.14 |
| Razuprotafib 20 mg | Length of Hospitalization From Baseline to Day 7 and Day 28 (or Death) | Day 28 | 14.6 Days | Standard Deviation 9.47 |
| Pooled Razuprotafib | Length of Hospitalization From Baseline to Day 7 and Day 28 (or Death) | Day 7 | 6.0 Days | Standard Deviation 1.67 |
| Pooled Razuprotafib | Length of Hospitalization From Baseline to Day 7 and Day 28 (or Death) | Day 28 | 14.4 Days | Standard Deviation 9.28 |
Secondary
Number of Participants Alive and Not Requiring Invasive Mechanical Ventilation at Any Time
Analysis of Number of Participants Alive and Not Requiring Invasive Mechanical Ventilation at Any Time Through Day 28 in the Full Analysis Set
Time frame: Baseline up to Day 28
Population: Full Analysis (FA) Population: The FA Population was a subset of the ITT Population and included participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy evaluation. Note: The overall number of participants analyzed represents the total number of participants in each treatment group for the FA Population. The count of participants who had post-baseline data and were alive and not requiring mechanical ventilation were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Alive and Not Requiring Invasive Mechanical Ventilation at Any Time | 9 Participants |
| Razuprotafib 10 mg | Number of Participants Alive and Not Requiring Invasive Mechanical Ventilation at Any Time | 6 Participants |
| Razuprotafib 20 mg | Number of Participants Alive and Not Requiring Invasive Mechanical Ventilation at Any Time | 8 Participants |
| Pooled Razuprotafib | Number of Participants Alive and Not Requiring Invasive Mechanical Ventilation at Any Time | 14 Participants |
Comparison: Pooled Razuprotafib comparison to Placebo. All results are summarized descriptively by treatment arm and expressed as proportions, along with corresponding 95% confidence intervals (CIs) of the difference between response rates, and p-values.p-value: 0.4795Cochran-Mantel-Haenszel
Secondary
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28
Summary of number and percent of subjects in each category (ie, categories 1 to 8) of the NIAID 8-Point Ordinal Scale at baseline, Day 7 and Day 28. The NIAID 8-point ordinal scale includes the following grades: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplementation oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized, limitation on activities and/or requiring home oxygen; and 8. Not hospitalized, no limitations on activities.
Time frame: Baseline, Day 7, and Day 28
Population: Intent-to-Treat (ITT) Population: The ITT Population was defined as all subjects randomized. Subjects in this population were analyzed according to the treatment group to which they were randomized. Note: The overall number of participants analyzed represents the total number of participants in each treatment group for the ITT Population. Those participants who had Baseline and post-baseline data on Days 7 and 28 were included in the analyses.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 3 | 2 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 1 | 0 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 5 | 0 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 3 | 0 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 8 | 4 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 2 | 0 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 4 | 1 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 6 | 0 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 8 | 1 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 3 | 4 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 5 | 0 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 2 | 0 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 1 | 0 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 4 | 6 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 2 | 0 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 5 | 0 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 1 | 0 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 7 | 4 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 6 | 0 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 8 | 0 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 7 | 5 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 4 | 0 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 7 | 0 Participants |
| Placebo | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 6 | 0 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 7 | 0 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 8 | 0 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 7 | 3 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 5 | 0 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 1 | 0 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 2 | 0 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 4 | 1 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 3 | 4 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 8 | 3 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 5 | 0 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 1 | 0 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 4 | 4 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 5 | 1 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 4 | 0 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 1 | 0 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 8 | 1 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 2 | 0 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 3 | 4 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 6 | 0 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 7 | 1 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 3 | 0 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 2 | 1 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 6 | 0 Participants |
| Razuprotafib 10 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 6 | 0 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 3 | 1 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 4 | 0 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 5 | 0 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 6 | 0 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 7 | 5 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 8 | 2 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 7 | 0 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 1 | 0 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 2 | 0 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 3 | 6 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 4 | 4 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 5 | 0 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 6 | 0 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 8 | 0 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 1 | 0 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 2 | 0 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 3 | 4 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 4 | 2 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 5 | 0 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 6 | 0 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 7 | 1 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 8 | 1 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 1 | 0 Participants |
| Razuprotafib 20 mg | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 2 | 1 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 5 | 0 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 7 | 0 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 6 | 0 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 4 | 0 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 6 | 0 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 5 | 1 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 3 | 10 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 2 | 2 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 7 | 2 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 2 | 0 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 1 | 0 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 5 | 0 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 8 | 2 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 4 | 8 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 8 | 5 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 3 | 1 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 1 | 0 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 3 | 8 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 2 | 0 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 7 | 8 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 4 | 3 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 7 | 1 | 0 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Baseline | 8 | 0 Participants |
| Pooled Razuprotafib | Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 | Day 28 | 6 | 0 Participants |
Secondary
Number of Participants Who Improve by at Least 2 Categories on the NIAID 8-point Ordinal Scale From Baseline to Day 7 and Baseline to Day 28
Analysis of the proportion of participants who improve by \>=2 categories on the NIAID 8-point scale from baseline to Day 7. % = 100 x n/N', where N' = number of participants with a non-missing values at baseline and the specified post-baseline visit. Baseline is defined as the last measurement prior to the first dose of study drug.
Time frame: from baseline to Day 7 and baseline to Day 28
Population: Full Analysis (FA) Population: The FA Population was a subset of the ITT Population and included participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy evaluation. Note: The overall number of participants analyzed represents the total number of participants in each treatment group for the FA Population. The count of participants who had NIAID 8-point scale results at the Day 7 and Day 28 timepoints were included in the analyses.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Who Improve by at Least 2 Categories on the NIAID 8-point Ordinal Scale From Baseline to Day 7 and Baseline to Day 28 | Participants who improved by >=2 categories from Baseline to Day 7 | 5 Participants |
| Placebo | Number of Participants Who Improve by at Least 2 Categories on the NIAID 8-point Ordinal Scale From Baseline to Day 7 and Baseline to Day 28 | Subjects who improved by >=2 categories from Baseline to Day 28 | 9 Participants |
| Razuprotafib 10 mg | Number of Participants Who Improve by at Least 2 Categories on the NIAID 8-point Ordinal Scale From Baseline to Day 7 and Baseline to Day 28 | Subjects who improved by >=2 categories from Baseline to Day 28 | 6 Participants |
| Razuprotafib 10 mg | Number of Participants Who Improve by at Least 2 Categories on the NIAID 8-point Ordinal Scale From Baseline to Day 7 and Baseline to Day 28 | Participants who improved by >=2 categories from Baseline to Day 7 | 2 Participants |
| Razuprotafib 20 mg | Number of Participants Who Improve by at Least 2 Categories on the NIAID 8-point Ordinal Scale From Baseline to Day 7 and Baseline to Day 28 | Participants who improved by >=2 categories from Baseline to Day 7 | 2 Participants |
| Razuprotafib 20 mg | Number of Participants Who Improve by at Least 2 Categories on the NIAID 8-point Ordinal Scale From Baseline to Day 7 and Baseline to Day 28 | Subjects who improved by >=2 categories from Baseline to Day 28 | 7 Participants |
| Pooled Razuprotafib | Number of Participants Who Improve by at Least 2 Categories on the NIAID 8-point Ordinal Scale From Baseline to Day 7 and Baseline to Day 28 | Participants who improved by >=2 categories from Baseline to Day 7 | 4 Participants |
| Pooled Razuprotafib | Number of Participants Who Improve by at Least 2 Categories on the NIAID 8-point Ordinal Scale From Baseline to Day 7 and Baseline to Day 28 | Subjects who improved by >=2 categories from Baseline to Day 28 | 13 Participants |
Secondary
Number of Participants Who Improve by Greater or Equal to 2 Categories on the NIAID 8-point Ordinal Scale From Baseline to Day 7 and Day 28
Analysis of number of participants who improve by \>= 2 categories on the NIAID 8-point scale from baseline to Day 7 and Day 28 in the full analysis set.% = 100 x n/N', where N' = number of participants with non-missing values at baseline and the specified post-baseline visit. Participants who died prior to the Day 7 or Day 28 were imputed as 1.
Time frame: Baseline to Day 7 and Day 28
Population: Full Analysis (FA) Population: The FA Population was a subset of the ITT Population and included participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy evaluation. Note: The overall number of participants analyzed represents the total number of participants in each treatment group for the FA Population. Those participants who had post-baseline data on Day 7 and 28 were included in analyses.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Who Improve by Greater or Equal to 2 Categories on the NIAID 8-point Ordinal Scale From Baseline to Day 7 and Day 28 | Participants who improve by >=2 categories on Day 7 | 5 Participants |
| Placebo | Number of Participants Who Improve by Greater or Equal to 2 Categories on the NIAID 8-point Ordinal Scale From Baseline to Day 7 and Day 28 | Participants who improve by >=2 categories on Day 28 | 9 Participants |
| Razuprotafib 10 mg | Number of Participants Who Improve by Greater or Equal to 2 Categories on the NIAID 8-point Ordinal Scale From Baseline to Day 7 and Day 28 | Participants who improve by >=2 categories on Day 28 | 6 Participants |
| Razuprotafib 10 mg | Number of Participants Who Improve by Greater or Equal to 2 Categories on the NIAID 8-point Ordinal Scale From Baseline to Day 7 and Day 28 | Participants who improve by >=2 categories on Day 7 | 2 Participants |
| Razuprotafib 20 mg | Number of Participants Who Improve by Greater or Equal to 2 Categories on the NIAID 8-point Ordinal Scale From Baseline to Day 7 and Day 28 | Participants who improve by >=2 categories on Day 7 | 2 Participants |
| Razuprotafib 20 mg | Number of Participants Who Improve by Greater or Equal to 2 Categories on the NIAID 8-point Ordinal Scale From Baseline to Day 7 and Day 28 | Participants who improve by >=2 categories on Day 28 | 7 Participants |
| Pooled Razuprotafib | Number of Participants Who Improve by Greater or Equal to 2 Categories on the NIAID 8-point Ordinal Scale From Baseline to Day 7 and Day 28 | Participants who improve by >=2 categories on Day 7 | 4 Participants |
| Pooled Razuprotafib | Number of Participants Who Improve by Greater or Equal to 2 Categories on the NIAID 8-point Ordinal Scale From Baseline to Day 7 and Day 28 | Participants who improve by >=2 categories on Day 28 | 13 Participants |
Secondary
Number of Participants Who Were Discharged and Free of Respiratory Failure Prior to Day 7 and Day 28
The number of participants who were discharged and free of respiratory failure at Day 7 and Day 28 were summarized by treatment arm and pooled razuprotafib (10 and 20 mg) group.
Time frame: Day 7 and Day 28
Population: Full Analysis (FA) Population: The FA Population was a subset of the ITT Population and included participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy evaluation. Note: The overall number of participants analyzed represents the total number of participants in each treatment group for the FA Population. The count of participants who were discharged and free of respiratory failure at the Day 7 and Day 28 timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Who Were Discharged and Free of Respiratory Failure Prior to Day 7 and Day 28 | Prior to Day 7 | 7 Participants |
| Placebo | Number of Participants Who Were Discharged and Free of Respiratory Failure Prior to Day 7 and Day 28 | Prior to Day 28 | 9 Participants |
| Razuprotafib 10 mg | Number of Participants Who Were Discharged and Free of Respiratory Failure Prior to Day 7 and Day 28 | Prior to Day 28 | 6 Participants |
| Razuprotafib 10 mg | Number of Participants Who Were Discharged and Free of Respiratory Failure Prior to Day 7 and Day 28 | Prior to Day 7 | 3 Participants |
| Razuprotafib 20 mg | Number of Participants Who Were Discharged and Free of Respiratory Failure Prior to Day 7 and Day 28 | Prior to Day 7 | 4 Participants |
| Razuprotafib 20 mg | Number of Participants Who Were Discharged and Free of Respiratory Failure Prior to Day 7 and Day 28 | Prior to Day 28 | 7 Participants |
| Pooled Razuprotafib | Number of Participants Who Were Discharged and Free of Respiratory Failure Prior to Day 7 and Day 28 | Prior to Day 7 | 7 Participants |
| Pooled Razuprotafib | Number of Participants Who Were Discharged and Free of Respiratory Failure Prior to Day 7 and Day 28 | Prior to Day 28 | 13 Participants |
Secondary
Number of Participants Who Worsen by Greater Than or Equal to 2 Categories on The NIAID 8-point Ordinal Scale From Baseline to Day 7 and Day 28
Analysis of number of participants who worsen by \>= 2 categories on the NIAID 8-point ordinal scale from baseline to Day 7 in the Full Analysis Population. % = 100 x n/N', where N' = number of participants with non-missing values at baseline and the specified post-baseline visit. Participants who died prior to the Day 7 or Day 28 were imputed as 1.
Time frame: From baseline to Day 7 and Day 28
Population: Full Analysis (FA) Population: The FA Population was a subset of the ITT Population and included participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy evaluation. Note: The overall number of participants analyzed represents the total number of participants in each treatment group for the FA Population. Those participants who had post-baseline data on Days 7 and 28 were included in the analyses.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Who Worsen by Greater Than or Equal to 2 Categories on The NIAID 8-point Ordinal Scale From Baseline to Day 7 and Day 28 | Participants who worsened by >= 2 categories from baseline to Day 28 | 1 Participants |
| Placebo | Number of Participants Who Worsen by Greater Than or Equal to 2 Categories on The NIAID 8-point Ordinal Scale From Baseline to Day 7 and Day 28 | Participants who worsened by >= 2 categories from baseline to Day 7 | 0 Participants |
| Razuprotafib 10 mg | Number of Participants Who Worsen by Greater Than or Equal to 2 Categories on The NIAID 8-point Ordinal Scale From Baseline to Day 7 and Day 28 | Participants who worsened by >= 2 categories from baseline to Day 28 | 1 Participants |
| Razuprotafib 10 mg | Number of Participants Who Worsen by Greater Than or Equal to 2 Categories on The NIAID 8-point Ordinal Scale From Baseline to Day 7 and Day 28 | Participants who worsened by >= 2 categories from baseline to Day 7 | 0 Participants |
| Razuprotafib 20 mg | Number of Participants Who Worsen by Greater Than or Equal to 2 Categories on The NIAID 8-point Ordinal Scale From Baseline to Day 7 and Day 28 | Participants who worsened by >= 2 categories from baseline to Day 28 | 1 Participants |
| Razuprotafib 20 mg | Number of Participants Who Worsen by Greater Than or Equal to 2 Categories on The NIAID 8-point Ordinal Scale From Baseline to Day 7 and Day 28 | Participants who worsened by >= 2 categories from baseline to Day 7 | 0 Participants |
| Pooled Razuprotafib | Number of Participants Who Worsen by Greater Than or Equal to 2 Categories on The NIAID 8-point Ordinal Scale From Baseline to Day 7 and Day 28 | Participants who worsened by >= 2 categories from baseline to Day 7 | 0 Participants |
| Pooled Razuprotafib | Number of Participants Who Worsen by Greater Than or Equal to 2 Categories on The NIAID 8-point Ordinal Scale From Baseline to Day 7 and Day 28 | Participants who worsened by >= 2 categories from baseline to Day 28 | 2 Participants |
Secondary
Summary of Change From Baseline in C-Reactive Protein (CRP) at Day 7 and 28
Change from baseline in systemic biomarkers of vascular leakage and inflammation (ie, CRP ) at Day 7 and 28 in the Full Analysis Set
Time frame: at Day 7 and 28
Population: Full Analysis (FA) Population: The FA Population was a subset of the ITT Population and included subjects who received at least 1 dose of study drug and had at least 1 post-dose efficacy evaluation. Note: The overall number of participants analyzed represents the total number of participants in each treatment group for the FA Population. The summaries of the mean change from baseline analyses included those participants who had post-baseline CRP values available on Days 7 and 28.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Summary of Change From Baseline in C-Reactive Protein (CRP) at Day 7 and 28 | Mean Change from Baseline at Day 7 | -13.17 mg/dL | Standard Deviation 21.8 |
| Placebo | Summary of Change From Baseline in C-Reactive Protein (CRP) at Day 7 and 28 | Baseline | 17.44 mg/dL | Standard Deviation 27.17 |
| Razuprotafib 10 mg | Summary of Change From Baseline in C-Reactive Protein (CRP) at Day 7 and 28 | Mean Change from Baseline at Day 7 | -29.55 mg/dL | Standard Deviation 60.99 |
| Razuprotafib 10 mg | Summary of Change From Baseline in C-Reactive Protein (CRP) at Day 7 and 28 | Baseline | 25.67 mg/dL | Standard Deviation 50.64 |
| Razuprotafib 20 mg | Summary of Change From Baseline in C-Reactive Protein (CRP) at Day 7 and 28 | Baseline | 23.01 mg/dL | Standard Deviation 45.95 |
| Razuprotafib 20 mg | Summary of Change From Baseline in C-Reactive Protein (CRP) at Day 7 and 28 | Mean change from baseline at Day 28 | -4.26 mg/dL | Standard Deviation 3.87 |
| Razuprotafib 20 mg | Summary of Change From Baseline in C-Reactive Protein (CRP) at Day 7 and 28 | Mean Change from Baseline at Day 7 | -22.64 mg/dL | Standard Deviation 47.95 |
Secondary
Summary of The Mean Change From Baseline in D-Dimer at Day 7 and 28
Mean Change from baseline in systemic biomarkers of vascular leakage and inflammation (ie, D-Dimer) at Day 7 and 28 in the Full Analysis Set
Time frame: at Day 7 and 28
Population: Full Analysis (FA) Population: The FA Population was a subset of the ITT Population and included subjects who received at least 1 dose of study drug and had at least 1 post-dose efficacy evaluation. Note: The overall number of participants analyzed represents the total number of participants in each treatment group for the FA Population. The summaries of the mean change from baseline analyses included those participants who had post-baseline D-Dimer values available on Days 7 and 28.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Summary of The Mean Change From Baseline in D-Dimer at Day 7 and 28 | Mean Change from Baseline at Day 7 | -144.5 ng/mL | Standard Deviation 133.63 |
| Placebo | Summary of The Mean Change From Baseline in D-Dimer at Day 7 and 28 | Baseline | 466.9 ng/mL | Standard Deviation 243.85 |
| Razuprotafib 10 mg | Summary of The Mean Change From Baseline in D-Dimer at Day 7 and 28 | Baseline | 1750.9 ng/mL | Standard Deviation 2137.46 |
| Razuprotafib 10 mg | Summary of The Mean Change From Baseline in D-Dimer at Day 7 and 28 | Mean Change from Baseline at Day 7 | 8913.4 ng/mL | Standard Deviation 16869.43 |
| Razuprotafib 20 mg | Summary of The Mean Change From Baseline in D-Dimer at Day 7 and 28 | Baseline | 823.2 ng/mL | Standard Deviation 787.39 |
| Razuprotafib 20 mg | Summary of The Mean Change From Baseline in D-Dimer at Day 7 and 28 | Mean Change from Baseline at Day 7 | 2239.0 ng/mL | Standard Deviation 5485.79 |
| Razuprotafib 20 mg | Summary of The Mean Change From Baseline in D-Dimer at Day 7 and 28 | Mean change from baseline at Day 28 | 2121.0 ng/mL | Standard Deviation 1566.95 |
Secondary
The Number and Percent of Participants Who Experienced All-Cause Mortality at Day 7 and Day 28
Analysis of the Number and Percent of Participants who Experienced All-Cause Mortality at Day 7 and Day 28 in the Full Analysis Set
Time frame: Baseline up to Day 7 and Day 28
Population: Full Analysis (FA) Population: The FA Population was a subset of the ITT Population and included subjects who received at least 1 dose of study drug and had at least 1 post-dose efficacy evaluation. Note: The overall number of participants analyzed represents the total number of participants in each treatment group for the FA Population. The participants who had post-baseline data on Days 7 and 28 were included in the all-cause mortality analyses.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | The Number and Percent of Participants Who Experienced All-Cause Mortality at Day 7 and Day 28 | All-Cause Mortality at Day 7 | 0 Participants |
| Placebo | The Number and Percent of Participants Who Experienced All-Cause Mortality at Day 7 and Day 28 | All-Cause Mortality at Day 28 | 1 Participants |
| Razuprotafib 10 mg | The Number and Percent of Participants Who Experienced All-Cause Mortality at Day 7 and Day 28 | All-Cause Mortality at Day 7 | 0 Participants |
| Razuprotafib 10 mg | The Number and Percent of Participants Who Experienced All-Cause Mortality at Day 7 and Day 28 | All-Cause Mortality at Day 28 | 1 Participants |
| Razuprotafib 20 mg | The Number and Percent of Participants Who Experienced All-Cause Mortality at Day 7 and Day 28 | All-Cause Mortality at Day 28 | 1 Participants |
| Razuprotafib 20 mg | The Number and Percent of Participants Who Experienced All-Cause Mortality at Day 7 and Day 28 | All-Cause Mortality at Day 7 | 0 Participants |
| Pooled Razuprotafib | The Number and Percent of Participants Who Experienced All-Cause Mortality at Day 7 and Day 28 | All-Cause Mortality at Day 28 | 2 Participants |
| Pooled Razuprotafib | The Number and Percent of Participants Who Experienced All-Cause Mortality at Day 7 and Day 28 | All-Cause Mortality at Day 7 | 0 Participants |
Secondary
Time to Reach Grade 6, 7, or 8 on the NIAID 8-Point Ordinal Scale
The clinical status of the participants was assessed within 1 hr prior to each dose of study drug, using the NIAID 8-point ordinal scale until Day 28. After the treatment period, clinical status will be assessed once daily until Day 18, unless discharged. If the subject is discharged alive prior to Day 28, clinical status was assessed at the post-treatment observation period telephone visits only. Grade 6=hospitalized, not requiring oxygen and no longer requires ongoing medical care; Grade 7 = not hospitalized, limitation on activities and/or requiring home oxygen; and Grade 8 = not hospitalized, no limitations on activities.
Time frame: From Screening through the end of the study (up to 28 days)
Population: Intent-to-Treat (ITT) Population: The ITT Population was defined as all subjects randomized. Participants in this population were analyzed according to the treatment group to which they were assigned at randomization. Note: The overall number of participants analyzed represents the total number of participants in each treatment group for the ITT Population. The number of participants included in the analyses had post-baseline data through the end of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Time to Reach Grade 6, 7, or 8 on the NIAID 8-Point Ordinal Scale | 9.8 days | Standard Deviation 5.87 |
| Razuprotafib 10 mg | Time to Reach Grade 6, 7, or 8 on the NIAID 8-Point Ordinal Scale | 11.7 days | Standard Deviation 7.87 |
| Razuprotafib 20 mg | Time to Reach Grade 6, 7, or 8 on the NIAID 8-Point Ordinal Scale | 11.7 days | Standard Deviation 5.47 |
| Pooled Razuprotafib | Time to Reach Grade 6, 7, or 8 on the NIAID 8-Point Ordinal Scale | 11.7 days | Standard Deviation 6.51 |
Secondary
Time to Return to Prehospitalization Oxygen Requirement
Summary of Time to Return to Prehospitalization Oxygen Requirement in the Intent-to-Treat Population
Time frame: up to 28 days
Population: Intent-to-Treat (ITT) Population: The ITT Population was defined as all participants randomized. Participants in this population were analyzed according to the treatment group to which they were assigned at randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Time to Return to Prehospitalization Oxygen Requirement | 5.1 Days | Standard Deviation 5.05 |
| Razuprotafib 10 mg | Time to Return to Prehospitalization Oxygen Requirement | 6.4 Days | Standard Deviation 7.83 |
| Razuprotafib 20 mg | Time to Return to Prehospitalization Oxygen Requirement | 9.7 Days | Standard Deviation 9.87 |
| Pooled Razuprotafib | Time to Return to Prehospitalization Oxygen Requirement | 7.4 Days | Standard Deviation 8.06 |
Other Pre-specified
Summary of Razuprotafib Plasma Concentration
A summary of plasma razuprotafib concentrations for samples collected on Day 1 and 6 in the pharmacokinetic population. All results were summarized descriptively by treatment group.
Time frame: razuprotafib plasma concentrations 30 and 90 minutes post-dose on Days 1 and 6
Population: Pharmacokinetic (PK) Population: The PK Population was defined as all randomized subjects who received at least 1 dose of study drug and had least 1 PK sample with plasma concentration.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Razuprotafib 10 mg | Summary of Razuprotafib Plasma Concentration | Razuprotafib plasma concentration 90 minutes post-dose on Day 1 | 64.68 ng/mL | Standard Deviation 21.29 |
| Razuprotafib 10 mg | Summary of Razuprotafib Plasma Concentration | Razuprotafib Plasma Concentration 90 minutes post-dose on Day 6 | 41.04 ng/mL | Standard Deviation 25.65 |
| Razuprotafib 10 mg | Summary of Razuprotafib Plasma Concentration | Razuprotafib Plasma Concentration 30 minutes post-dose on Day 6 | 64.98 ng/mL | Standard Deviation 41.03 |
| Razuprotafib 10 mg | Summary of Razuprotafib Plasma Concentration | Razuprotafib Plasma Concentration 30 minutes post-dose on Day 1 | 87.88 ng/mL | Standard Deviation 33.24 |
| Razuprotafib 20 mg | Summary of Razuprotafib Plasma Concentration | Razuprotafib plasma concentration 90 minutes post-dose on Day 1 | 124.57 ng/mL | Standard Deviation 33.88 |
| Razuprotafib 20 mg | Summary of Razuprotafib Plasma Concentration | Razuprotafib Plasma Concentration 30 minutes post-dose on Day 1 | 194.73 ng/mL | Standard Deviation 67.2 |
| Razuprotafib 20 mg | Summary of Razuprotafib Plasma Concentration | Razuprotafib Plasma Concentration 30 minutes post-dose on Day 6 | 105.82 ng/mL | Standard Deviation 71.99 |
| Razuprotafib 20 mg | Summary of Razuprotafib Plasma Concentration | Razuprotafib Plasma Concentration 90 minutes post-dose on Day 6 | 78.48 ng/mL | Standard Deviation 56.13 |