Trial Outcomes & Findings for Evaluation of the Safety and Efficacy of Razuprotafib in Hospitalized Subjects With Coronavirus Disease 2019 (NCT NCT04511650)

Last Updated: 2023-06-08

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

31 participants

Primary outcome timeframe

Baseline up to Day 7 and Day 28

Results posted on

2023-06-08

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Razuprotafib 10 mg Razuprotafib 10 mg 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.	Razuprotafib 20 mg Razuprotafib 20 mg 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.	Placebo Placebo Subcutaneous Solution: Matched vehicle-controlled placebo solution will be administered subcutaneously three times daily (Q8H) for 7 days
Overall Study STARTED	10	10	11
Overall Study Subjects Treated	9	10	10
Overall Study Subjects Randomized But Not Treated	1	0	1
Overall Study COMPLETED	7	9	9
Overall Study NOT COMPLETED	3	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Razuprotafib 10 mg Razuprotafib 10 mg 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.	Razuprotafib 20 mg Razuprotafib 20 mg 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.	Placebo Placebo Subcutaneous Solution: Matched vehicle-controlled placebo solution will be administered subcutaneously three times daily (Q8H) for 7 days
Overall Study Lost to Follow-up	1	0	0
Overall Study Withdrawal by Subject	1	0	0
Overall Study reason not provided	0	0	1
Overall Study Death	1	1	1

Baseline Characteristics

n= the number of participants included in the ratio mean (SD) calculation as shown in Table 3 of the demographics and baseline characteristics table for the ITT population. One subject in each of the Razuprotafib 10mg and placebo group were randomized and not treated; therefore, these two subjects are not included in the analyses.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Razuprotafib 10mg n=10 Participants 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.	Razuprotafib 20mg n=10 Participants 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.	Placebo n=11 Participants Placebo Subcutaneous Solution: Matched vehicle-controlled placebo solution will be administered subcutaneously three times daily (Q8H) for 7 days	Total n=31 Participants Total of all reporting groups
Age, Customized Age at Informed Consent	58.3 years STANDARD_DEVIATION 11.52 • n=10 Participants	53.4 years STANDARD_DEVIATION 16.55 • n=10 Participants	62.7 years STANDARD_DEVIATION 15.81 • n=11 Participants	58.3 years STANDARD_DEVIATION 14.85 • n=31 Participants
Sex: Female, Male Female	1 Participants n=10 Participants	2 Participants n=10 Participants	5 Participants n=11 Participants	8 Participants n=31 Participants
Sex: Female, Male Male	9 Participants n=10 Participants	8 Participants n=10 Participants	6 Participants n=11 Participants	23 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=10 Participants	3 Participants n=10 Participants	0 Participants n=11 Participants	7 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=10 Participants	7 Participants n=10 Participants	11 Participants n=11 Participants	23 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=11 Participants	1 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=11 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Asian	1 Participants n=10 Participants	1 Participants n=10 Participants	0 Participants n=11 Participants	2 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	1 Participants n=10 Participants	0 Participants n=11 Participants	1 Participants n=31 Participants
Race (NIH/OMB) Black or African American	3 Participants n=10 Participants	0 Participants n=10 Participants	3 Participants n=11 Participants	6 Participants n=31 Participants
Race (NIH/OMB) White	4 Participants n=10 Participants	7 Participants n=10 Participants	8 Participants n=11 Participants	19 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=11 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=10 Participants	1 Participants n=10 Participants	0 Participants n=11 Participants	3 Participants n=31 Participants
Coronavirus disease (COVID-19) severity, n (%) Moderate	3 Participants n=10 Participants	2 Participants n=10 Participants	3 Participants n=11 Participants	8 Participants n=31 Participants
Coronavirus disease (COVID-19) severity, n (%) Severe	7 Participants n=10 Participants	8 Participants n=10 Participants	8 Participants n=11 Participants	23 Participants n=31 Participants
National Institutes of Allergy and Infectious Diseases Category 1 = Death	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=11 Participants	0 Participants n=31 Participants
National Institutes of Allergy and Infectious Diseases Category 2 = Hospitalized on mechanical ventilation	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=11 Participants	0 Participants n=31 Participants
National Institutes of Allergy and Infectious Diseases Category 3 = Hospitalized, on noninvasive ventilation or high-flow oxygen devices	4 Participants n=10 Participants	5 Participants n=10 Participants	4 Participants n=11 Participants	13 Participants n=31 Participants
National Institutes of Allergy and Infectious Diseases Category 4= Hospitalized, requiring supplemental oxygen	5 Participants n=10 Participants	5 Participants n=10 Participants	6 Participants n=11 Participants	16 Participants n=31 Participants
National Institutes of Allergy and Infectious Diseases Category 5= Hospitalized, not requiring supplemental oxygen - requiring ongoing COVID-19 care	1 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=11 Participants	2 Participants n=31 Participants
National Institutes of Allergy and Infectious Diseases Category 6= Hospitalized, not requiring supplemental oxygen - no longer requires medical care	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=11 Participants	0 Participants n=31 Participants
National Institutes of Allergy and Infectious Diseases Category 7=Not hospitalized, limitation on activities or requiring home oxygen	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=11 Participants	0 Participants n=31 Participants
National Institutes of Allergy and Infectious Diseases Category 8= Not hospitalized, no limitations on activities	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=11 Participants	0 Participants n=31 Participants
Screening Peripheral Oxygen Saturation (Pa02)/Fraction of Inspired Oxygen (FiO2) ratio	194.97 ratio STANDARD_DEVIATION 131.546 • n=9 Participants • n= the number of participants included in the ratio mean (SD) calculation as shown in Table 3 of the demographics and baseline characteristics table for the ITT population. One subject in each of the Razuprotafib 10mg and placebo group were randomized and not treated; therefore, these two subjects are not included in the analyses.	146.15 ratio STANDARD_DEVIATION 80.602 • n=9 Participants • n= the number of participants included in the ratio mean (SD) calculation as shown in Table 3 of the demographics and baseline characteristics table for the ITT population. One subject in each of the Razuprotafib 10mg and placebo group were randomized and not treated; therefore, these two subjects are not included in the analyses.	212.40 ratio STANDARD_DEVIATION 132.210 • n=10 Participants • n= the number of participants included in the ratio mean (SD) calculation as shown in Table 3 of the demographics and baseline characteristics table for the ITT population. One subject in each of the Razuprotafib 10mg and placebo group were randomized and not treated; therefore, these two subjects are not included in the analyses.	186.71 ratio STANDARD_DEVIATION 118.212 • n=28 Participants • n= the number of participants included in the ratio mean (SD) calculation as shown in Table 3 of the demographics and baseline characteristics table for the ITT population. One subject in each of the Razuprotafib 10mg and placebo group were randomized and not treated; therefore, these two subjects are not included in the analyses.
Pre-hospitalization oxygen requirement, n (%) None	7 Participants n=10 Participants	10 Participants n=10 Participants	10 Participants n=11 Participants	27 Participants n=31 Participants
Pre-hospitalization oxygen requirement, n (%) Low-flow nasal cannula	2 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=11 Participants	3 Participants n=31 Participants
Pre-hospitalization oxygen requirement, n (%) CPAP mask (for non-respiratory failure reasons)	1 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=11 Participants	1 Participants n=31 Participants
Concomitant medications to treat COVID-19 at baseline, n (%) Remdesivir	3 Participants n=10 Participants	6 Participants n=10 Participants	8 Participants n=11 Participants	17 Participants n=31 Participants
Concomitant medications to treat COVID-19 at baseline, n (%) Systemic steroids	8 Participants n=10 Participants	10 Participants n=10 Participants	10 Participants n=11 Participants	28 Participants n=31 Participants
Concomitant medications to treat COVID-19 at baseline, n (%) Other	6 Participants n=10 Participants	8 Participants n=10 Participants	4 Participants n=11 Participants	18 Participants n=31 Participants
Concomitant medications to treat COVID-19 at baseline, n (%) None	1 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=11 Participants	2 Participants n=31 Participants
Comorbid conditions, n (%) Diabetes	3 Participants n=10 Participants	4 Participants n=10 Participants	6 Participants n=11 Participants	13 Participants n=31 Participants
Comorbid conditions, n (%) Obesity	4 Participants n=10 Participants	4 Participants n=10 Participants	2 Participants n=11 Participants	10 Participants n=31 Participants
Comorbid conditions, n (%) Hypertension	8 Participants n=10 Participants	6 Participants n=10 Participants	5 Participants n=11 Participants	19 Participants n=31 Participants
Comorbid conditions, n (%) Heart Failure	1 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=11 Participants	1 Participants n=31 Participants
Comorbid conditions, n (%) Chronic Kidney Disease	1 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=11 Participants	2 Participants n=31 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Placebo for razuprotafib was sterile normal saline	Razuprotafib 10 mg n=9 Participants 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.	Razuprotafib 20 mg n=10 Participants 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.	Pooled Razuprotafib n=19 Participants Razuprotafib 10 and 20 mg pooled
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	5 Participants	6 Participants	11 Participants
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	6 Participants	7 Participants	13 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Placebo for razuprotafib was sterile normal saline	Razuprotafib 10 mg n=9 Participants 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.	Razuprotafib 20 mg n=10 Participants 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.	Pooled Razuprotafib Razuprotafib 10 and 20 mg pooled
Summary of The Mean Change From Baseline in D-Dimer at Day 7 and 28 Baseline	466.9 ng/mL Standard Deviation 243.85	1750.9 ng/mL Standard Deviation 2137.46	823.2 ng/mL Standard Deviation 787.39	—
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	8913.4 ng/mL Standard Deviation 16869.43	2239.0 ng/mL Standard Deviation 5485.79	—
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 outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Placebo for razuprotafib was sterile normal saline	Razuprotafib 10 mg n=9 Participants 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.	Razuprotafib 20 mg n=10 Participants 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.	Pooled Razuprotafib Razuprotafib 10 and 20 mg pooled
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 21.80	-29.55 mg/dL Standard Deviation 60.99	-22.64 mg/dL Standard Deviation 47.95	—
Summary of Change From Baseline in C-Reactive Protein (CRP) at Day 7 and 28 Baseline	17.44 mg/dL Standard Deviation 27.17	25.67 mg/dL Standard Deviation 50.64	23.01 mg/dL Standard Deviation 45.95	—
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	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Placebo for razuprotafib was sterile normal saline	Razuprotafib 10 mg n=9 Participants 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.	Razuprotafib 20 mg n=10 Participants 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.	Pooled Razuprotafib n=19 Participants Razuprotafib 10 and 20 mg pooled
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	6 Participants	7 Participants	13 Participants
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	2 Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Placebo for razuprotafib was sterile normal saline	Razuprotafib 10 mg n=9 Participants 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.	Razuprotafib 20 mg n=10 Participants 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.	Pooled Razuprotafib n=19 Participants Razuprotafib 10 and 20 mg pooled
Number of Participants Who Were Discharged and Free of Respiratory Failure Prior to Day 7 and Day 28 Prior to Day 7	7 Participants	3 Participants	4 Participants	7 Participants
Number of Participants Who Were Discharged and Free of Respiratory Failure Prior to Day 7 and Day 28 Prior to Day 28	9 Participants	6 Participants	7 Participants	13 Participants

SECONDARY outcome

Timeframe: 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.

Analysis of Number of Participants Alive and Not Requiring Invasive Mechanical Ventilation at Any Time Through Day 28 in the Full Analysis Set

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Placebo for razuprotafib was sterile normal saline	Razuprotafib 10 mg n=8 Participants 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.	Razuprotafib 20 mg n=10 Participants 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.	Pooled Razuprotafib n=18 Participants Razuprotafib 10 and 20 mg pooled
Number of Participants Alive and Not Requiring Invasive Mechanical Ventilation at Any Time	9 Participants	6 Participants	8 Participants	14 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Placebo for razuprotafib was sterile normal saline	Razuprotafib 10 mg n=7 Participants 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.	Razuprotafib 20 mg n=7 Participants 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.	Pooled Razuprotafib n=14 Participants Razuprotafib 10 and 20 mg pooled
Time to Reach Grade 6, 7, or 8 on the NIAID 8-Point Ordinal Scale	9.8 days Standard Deviation 5.87	11.7 days Standard Deviation 7.87	11.7 days Standard Deviation 5.47	11.7 days Standard Deviation 6.51

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Placebo for razuprotafib was sterile normal saline	Razuprotafib 10 mg n=10 Participants 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.	Razuprotafib 20 mg n=10 Participants 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.	Pooled Razuprotafib n=20 Participants Razuprotafib 10 and 20 mg pooled
Change in PaO2:FiO2 Ratio From Baseline to Day 7 and Baseline to Day 28 Day 7	27.44 ratio Standard Deviation 55.259	18.81 ratio Standard Deviation 82.833	48.34 ratio Standard Deviation 81.008	34.92 ratio Standard Deviation 79.142
Change in PaO2:FiO2 Ratio From Baseline to Day 7 and Baseline to Day 28 Day 28	140.95 ratio Standard Deviation 76.887	96.21 ratio Standard Deviation 155.077	117.01 ratio Standard Deviation 87.030	110.08 ratio Standard Deviation 97.312
Change in PaO2:FiO2 Ratio From Baseline to Day 7 and Baseline to Day 28 Baseline	212.40 ratio Standard Deviation 132.210	194.97 ratio Standard Deviation 131.546	146.15 ratio Standard Deviation 80.602	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Placebo for razuprotafib was sterile normal saline	Razuprotafib 10 mg n=10 Participants 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.	Razuprotafib 20 mg n=10 Participants 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.	Pooled Razuprotafib n=20 Participants Razuprotafib 10 and 20 mg pooled
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 1.70	5.8 Days Standard Deviation 2.17	6.2 Days Standard Deviation 1.14	6.0 Days Standard Deviation 1.67
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	9.9 Days Standard Deviation 6.64	12.7 Days Standard Deviation 8.31	11.4 Days Standard Deviation 7.54

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Placebo for razuprotafib was sterile normal saline	Razuprotafib 10 mg n=10 Participants 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.	Razuprotafib 20 mg n=10 Participants 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.	Pooled Razuprotafib n=20 Participants Razuprotafib 10 and 20 mg pooled
Length of Hospitalization From Baseline to Day 7 and Day 28 (or Death) Day 7	5.0 Days Standard Deviation 1.70	5.8 Days Standard Deviation 2.17	6.2 Days Standard Deviation 1.14	6.0 Days Standard Deviation 1.67
Length of Hospitalization From Baseline to Day 7 and Day 28 (or Death) Day 28	7.2 Days Standard Deviation 4.69	14.1 Days Standard Deviation 9.69	14.6 Days Standard Deviation 9.47	14.4 Days Standard Deviation 9.28

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Placebo for razuprotafib was sterile normal saline	Razuprotafib 10 mg n=9 Participants 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.	Razuprotafib 20 mg n=10 Participants 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.	Pooled Razuprotafib n=19 Participants Razuprotafib 10 and 20 mg pooled
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	0 Participants	0 Participants	0 Participants
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	1 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Placebo for razuprotafib was sterile normal saline	Razuprotafib 10 mg n=10 Participants 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.	Razuprotafib 20 mg n=10 Participants 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.	Pooled Razuprotafib n=20 Participants Razuprotafib 10 and 20 mg pooled
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Baseline · 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Baseline · 6	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Baseline · 8	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Day 7 · 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Day 7 · 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Day 7 · 6	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Day 7 · 7	4 Participants	1 Participants	1 Participants	2 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Day 7 · 8	1 Participants	1 Participants	1 Participants	2 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Day 28 · 2	0 Participants	1 Participants	1 Participants	2 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Day 28 · 3	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Day 28 · 4	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Day 28 · 5	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Day 28 · 6	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Day 28 · 7	5 Participants	3 Participants	5 Participants	8 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Baseline · 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Baseline · 3	4 Participants	4 Participants	6 Participants	10 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Baseline · 4	6 Participants	4 Participants	4 Participants	8 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Baseline · 5	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Baseline · 7	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Day 7 · 2	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Day 7 · 3	2 Participants	4 Participants	4 Participants	8 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Day 7 · 4	1 Participants	1 Participants	2 Participants	3 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Day 28 · 1	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants in Each Category of the NIAID 8-point Ordinal Scale at Day 7 and Day 28 Day 28 · 8	4 Participants	3 Participants	2 Participants	5 Participants

SECONDARY outcome

Timeframe: 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.

Analysis of the Number and Percent of Participants who Experienced All-Cause Mortality at Day 7 and Day 28 in the Full Analysis Set

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Placebo for razuprotafib was sterile normal saline	Razuprotafib 10 mg n=9 Participants 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.	Razuprotafib 20 mg n=10 Participants 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.	Pooled Razuprotafib n=19 Participants Razuprotafib 10 and 20 mg pooled
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	1 Participants	1 Participants	2 Participants
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	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Placebo for razuprotafib was sterile normal saline	Razuprotafib 10 mg n=9 Participants 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.	Razuprotafib 20 mg n=10 Participants 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.	Pooled Razuprotafib n=19 Participants Razuprotafib 10 and 20 mg pooled
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	2 Participants	2 Participants	4 Participants
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	6 Participants	7 Participants	13 Participants

SECONDARY outcome

Timeframe: 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.

Summary of Time to Return to Prehospitalization Oxygen Requirement in the Intent-to-Treat Population

Outcome measures

Outcome measures
Measure	Placebo n=7 Participants Placebo for razuprotafib was sterile normal saline	Razuprotafib 10 mg n=7 Participants 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.	Razuprotafib 20 mg n=3 Participants 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.	Pooled Razuprotafib n=10 Participants Razuprotafib 10 and 20 mg pooled
Time to Return to Prehospitalization Oxygen Requirement	5.1 Days Standard Deviation 5.05	6.4 Days Standard Deviation 7.83	9.7 Days Standard Deviation 9.87	7.4 Days Standard Deviation 8.06

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo Placebo for razuprotafib was sterile normal saline	Razuprotafib 10 mg n=9 Participants 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.	Razuprotafib 20 mg n=10 Participants 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.	Pooled Razuprotafib Razuprotafib 10 and 20 mg pooled
Summary of Razuprotafib Plasma Concentration Razuprotafib Plasma Concentration 90 minutes post-dose on Day 6	—	41.04 ng/mL Standard Deviation 25.65	78.48 ng/mL Standard Deviation 56.13	—
Summary of Razuprotafib Plasma Concentration Razuprotafib Plasma Concentration 30 minutes post-dose on Day 1	—	87.88 ng/mL Standard Deviation 33.24	194.73 ng/mL Standard Deviation 67.20	—
Summary of Razuprotafib Plasma Concentration Razuprotafib plasma concentration 90 minutes post-dose on Day 1	—	64.68 ng/mL Standard Deviation 21.29	124.57 ng/mL Standard Deviation 33.88	—
Summary of Razuprotafib Plasma Concentration Razuprotafib Plasma Concentration 30 minutes post-dose on Day 6	—	64.98 ng/mL Standard Deviation 41.03	105.82 ng/mL Standard Deviation 71.99	—

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 6 other events

Deaths: 1 deaths

Razuprotafib 10 mg

Serious events: 2 serious events

Other events: 7 other events

Deaths: 1 deaths

Razuprotafib 20 mg

Serious events: 5 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=10 participants at risk Placebo Subcutaneous Solution: Matched vehicle-controlled placebo solution will be administered subcutaneously three times daily (Q8H) for 7 days	Razuprotafib 10 mg n=9 participants at risk 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.	Razuprotafib 20 mg n=10 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	10.0% 1/10 • Number of events 1 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.	22.2% 2/9 • Number of events 2 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.	20.0% 2/10 • Number of events 2 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.
Infections and infestations COVID-19 viral pneumonia	10.0% 1/10 • Number of events 1 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.	0.00% 0/9 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.	0.00% 0/10 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.
Infections and infestations Bacterial pneumonia	0.00% 0/10 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.	11.1% 1/9 • Number of events 1 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.	10.0% 1/10 • Number of events 1 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.
Infections and infestations septic shock	0.00% 0/10 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.	11.1% 1/9 • Number of events 1 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.	10.0% 1/10 • Number of events 1 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.
Injury, poisoning and procedural complications post-procedural hemorrhage	0.00% 0/10 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.	11.1% 1/9 • Number of events 1 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.	0.00% 0/10 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.
Cardiac disorders Transient hypotension	0.00% 0/10 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.	11.1% 1/9 • Number of events 1 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.	0.00% 0/10 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.00% 0/10 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.	0.00% 0/9 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.	10.0% 1/10 • Number of events 1 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/10 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.	0.00% 0/9 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.	10.0% 1/10 • Number of events 1 • Adverse events will be monitored at the time of screening until Day 28. Serious Adverse Events (SAEs) will be reported 30 days after the last dose of study treatment.

Other adverse events

Additional Information

Dario Paggiarino, MD

EyePoint Pharmaceuticals, Inc.

Phone: 8589670016

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Product acquired from Aerpio with limited transfer of documents. Site Clinical Trial Agreements (CTAs) not provided.
Publication restrictions are in place

Restriction type: OTHER