Trial Outcomes & Findings for Study of Varespladib in Patients Hospitalized With Severe COVID-19 (NCT NCT04969991)
NCT ID: NCT04969991
Last Updated: 2025-05-15
Results Overview
The proportion of respiratory failure-free surviving participants in each Part 2 treatment group at Day 28 will be analyzed using the Mantel-Haenszel stratum-weighted estimator with treatment as a factor. Respiratory failure is defined based on resource utilization requiring at least one of the following: * Endotracheal intubation and mechanical ventilation * Oxygen delivered by high-flow nasal cannula (\[HFNC\] heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20 L/min with fraction of delivered oxygen ≥0.5) * Noninvasive positive pressure ventilation * ECMO, or * Clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting because of resource limitation)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Baseline to Day 28
Results posted on
2025-05-15
Participant Flow
Participant milestones
| Measure |
Varespladib: 250 mg QD + Placebo + Placebo
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon and 1 placebo tablet in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg BID + Placebo
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning and in the evening. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg TID
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning, in the afternoon, and in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
|
Placebo
For 7 days, and in addition to institutional standard of care, participants will take 1 placebo tablet in the morning, in the afternoon, and in the evening.
Placebo: Oral formulation matched to the oral varespladib tablet
|
|---|---|---|---|---|
|
Part 1
STARTED
|
5
|
5
|
5
|
3
|
|
Part 1
COMPLETED
|
4
|
4
|
5
|
3
|
|
Part 1
NOT COMPLETED
|
1
|
1
|
0
|
0
|
|
Part 2
STARTED
|
0
|
0
|
0
|
1
|
|
Part 2
COMPLETED
|
0
|
0
|
0
|
1
|
|
Part 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Varespladib in Patients Hospitalized With Severe COVID-19
Baseline characteristics by cohort
| Measure |
Varespladib: 250 mg QD + Placebo + Placebo
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon and 1 placebo tablet in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg BID + Placebo
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning and in the evening. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg TID
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning, in the afternoon, and in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
|
Placebo
n=3 Participants
For 7 days, and in addition to institutional standard of care, participants will take 1 placebo tablet in the morning, in the afternoon, and in the evening.
Placebo: Oral formulation matched to the oral varespladib tablet
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 22.9 • n=5 Participants
|
42.6 years
STANDARD_DEVIATION 17.1 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 15.7 • n=4 Participants
|
50.4 years
STANDARD_DEVIATION 17.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 28The proportion of respiratory failure-free surviving participants in each Part 2 treatment group at Day 28 will be analyzed using the Mantel-Haenszel stratum-weighted estimator with treatment as a factor. Respiratory failure is defined based on resource utilization requiring at least one of the following: * Endotracheal intubation and mechanical ventilation * Oxygen delivered by high-flow nasal cannula (\[HFNC\] heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20 L/min with fraction of delivered oxygen ≥0.5) * Noninvasive positive pressure ventilation * ECMO, or * Clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting because of resource limitation)
Outcome measures
| Measure |
Varespladib: 250 mg QD + Placebo + Placebo
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon and 1 placebo tablet in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg BID + Placebo
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning and in the evening. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg TID
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning, in the afternoon, and in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
|
Placebo
n=3 Participants
For 7 days, and in addition to institutional standard of care, participants will take 1 placebo tablet in the morning, in the afternoon, and in the evening.
Placebo: Oral formulation matched to the oral varespladib tablet
|
|---|---|---|---|---|
|
Proportion of Participants Alive and Free of Respiratory Failure at Day 28
|
4 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From randomization through Day 28The proportion of subjects using HFNC within the first 28 days after randomization.
Outcome measures
| Measure |
Varespladib: 250 mg QD + Placebo + Placebo
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon and 1 placebo tablet in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg BID + Placebo
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning and in the evening. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg TID
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning, in the afternoon, and in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
|
Placebo
n=3 Participants
For 7 days, and in addition to institutional standard of care, participants will take 1 placebo tablet in the morning, in the afternoon, and in the evening.
Placebo: Oral formulation matched to the oral varespladib tablet
|
|---|---|---|---|---|
|
Proportion of Subjects Using HFNC Within the First 28 Days After Randomization
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From randomization through Day 28Proportion of subjects using noninvasive respiratory support within the first 28 days after randomization.
Outcome measures
| Measure |
Varespladib: 250 mg QD + Placebo + Placebo
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon and 1 placebo tablet in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg BID + Placebo
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning and in the evening. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg TID
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning, in the afternoon, and in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
|
Placebo
n=3 Participants
For 7 days, and in addition to institutional standard of care, participants will take 1 placebo tablet in the morning, in the afternoon, and in the evening.
Placebo: Oral formulation matched to the oral varespladib tablet
|
|---|---|---|---|---|
|
Proportion of Subjects Using Noninvasive Respiratory Support Within the First 28 Days After Randomization
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From randomization through Day 28Proportion of subjects using mechanical ventilation within the first 28 days after randomization.
Outcome measures
| Measure |
Varespladib: 250 mg QD + Placebo + Placebo
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon and 1 placebo tablet in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg BID + Placebo
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning and in the evening. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg TID
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning, in the afternoon, and in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
|
Placebo
n=3 Participants
For 7 days, and in addition to institutional standard of care, participants will take 1 placebo tablet in the morning, in the afternoon, and in the evening.
Placebo: Oral formulation matched to the oral varespladib tablet
|
|---|---|---|---|---|
|
Proportion of Subjects Using Mechanical Ventilation Within the First 28 Days After Randomization
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From randomization through Day 28Number of days of oxygen support through Day 28 after randomization.
Outcome measures
| Measure |
Varespladib: 250 mg QD + Placebo + Placebo
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon and 1 placebo tablet in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg BID + Placebo
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning and in the evening. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg TID
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning, in the afternoon, and in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
|
Placebo
n=3 Participants
For 7 days, and in addition to institutional standard of care, participants will take 1 placebo tablet in the morning, in the afternoon, and in the evening.
Placebo: Oral formulation matched to the oral varespladib tablet
|
|---|---|---|---|---|
|
Number of Days of Oxygen Support Through Day 28 After Randomization
|
9 days
Standard Deviation 11
|
6 days
Standard Deviation 8
|
12 days
Standard Deviation 11
|
11 days
Standard Deviation 15
|
SECONDARY outcome
Timeframe: From randomization through Day 28Proportion of participants remaining free of mechanical ventilation or ECMO throughout the 28 days after randomization.
Outcome measures
| Measure |
Varespladib: 250 mg QD + Placebo + Placebo
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon and 1 placebo tablet in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg BID + Placebo
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning and in the evening. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg TID
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning, in the afternoon, and in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
|
Placebo
n=3 Participants
For 7 days, and in addition to institutional standard of care, participants will take 1 placebo tablet in the morning, in the afternoon, and in the evening.
Placebo: Oral formulation matched to the oral varespladib tablet
|
|---|---|---|---|---|
|
Proportion of Participants Remaining Free of Mechanical Ventilation or ECMO Throughout the 28 Days After Randomization
|
4 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From randomization through Day 60Proportion of subjects who experience all-cause mortality from randomization through Day 60.
Outcome measures
| Measure |
Varespladib: 250 mg QD + Placebo + Placebo
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon and 1 placebo tablet in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg BID + Placebo
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning and in the evening. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg TID
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning, in the afternoon, and in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
|
Placebo
n=3 Participants
For 7 days, and in addition to institutional standard of care, participants will take 1 placebo tablet in the morning, in the afternoon, and in the evening.
Placebo: Oral formulation matched to the oral varespladib tablet
|
|---|---|---|---|---|
|
Proportion of Subjects With All-cause Mortality Through Day 60
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From providing informed consent through Day 60Number of participants with change in body temperature from providing informed consent through Day 60.
Outcome measures
| Measure |
Varespladib: 250 mg QD + Placebo + Placebo
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon and 1 placebo tablet in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg BID + Placebo
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning and in the evening. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg TID
n=5 Participants
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning, in the afternoon, and in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
|
Placebo
n=3 Participants
For 7 days, and in addition to institutional standard of care, participants will take 1 placebo tablet in the morning, in the afternoon, and in the evening.
Placebo: Oral formulation matched to the oral varespladib tablet
|
|---|---|---|---|---|
|
Number of Participants With Change in Body Temperature
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28Changes from baseline to Day 28 in SF-12 scores, which range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From treatment initiation through Day 28Changes in observed sPLA2 values
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 through Day 3Change in AUC from Day 1 through Day 3
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 through Day 3Change in Cmax from Day 1 through Day 3
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 through Day 3Change in Tmax from Day 1 through Day 3
Outcome measures
Outcome data not reported
Adverse Events
Varespladib: 250 mg QD + Placebo + Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Varespladib: 250 mg BID + Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Varespladib: 250 mg TID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varespladib: 250 mg QD + Placebo + Placebo
n=5 participants at risk
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon and 1 placebo tablet in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg BID + Placebo
n=5 participants at risk
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning and in the evening. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg TID
n=5 participants at risk
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning, in the afternoon, and in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
|
Placebo
n=3 participants at risk
For 7 days, and in addition to institutional standard of care, participants will take 1 placebo tablet in the morning, in the afternoon, and in the evening.
Placebo: Oral formulation matched to the oral varespladib tablet
|
|---|---|---|---|---|
|
Infections and infestations
Progression of COVID 19
|
20.0%
1/5 • Number of events 1 • Treatment-emergent AEs were events that occurred or worsened on or after the first dose of study intervention and prior to the 30 days after last administration of study intervention. AEs were reported through 60 days after randomization.
|
0.00%
0/5 • Treatment-emergent AEs were events that occurred or worsened on or after the first dose of study intervention and prior to the 30 days after last administration of study intervention. AEs were reported through 60 days after randomization.
|
0.00%
0/5 • Treatment-emergent AEs were events that occurred or worsened on or after the first dose of study intervention and prior to the 30 days after last administration of study intervention. AEs were reported through 60 days after randomization.
|
0.00%
0/3 • Treatment-emergent AEs were events that occurred or worsened on or after the first dose of study intervention and prior to the 30 days after last administration of study intervention. AEs were reported through 60 days after randomization.
|
|
Infections and infestations
Pulmonary embolism & COVID 19 Pneumonia
|
0.00%
0/5 • Treatment-emergent AEs were events that occurred or worsened on or after the first dose of study intervention and prior to the 30 days after last administration of study intervention. AEs were reported through 60 days after randomization.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent AEs were events that occurred or worsened on or after the first dose of study intervention and prior to the 30 days after last administration of study intervention. AEs were reported through 60 days after randomization.
|
0.00%
0/5 • Treatment-emergent AEs were events that occurred or worsened on or after the first dose of study intervention and prior to the 30 days after last administration of study intervention. AEs were reported through 60 days after randomization.
|
0.00%
0/3 • Treatment-emergent AEs were events that occurred or worsened on or after the first dose of study intervention and prior to the 30 days after last administration of study intervention. AEs were reported through 60 days after randomization.
|
Other adverse events
| Measure |
Varespladib: 250 mg QD + Placebo + Placebo
n=5 participants at risk
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon and 1 placebo tablet in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg BID + Placebo
n=5 participants at risk
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning and in the evening. In order to maintain the blind, they will also take 1 placebo tablet in the afternoon.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
Placebo: Oral formulation matched to the oral varespladib tablet
|
Varespladib: 250 mg TID
n=5 participants at risk
For 7 days, and in addition to institutional standard of care, participants will take 250 mg varespladib in the morning, in the afternoon, and in the evening.
Varespladib: 250 mg immediate-release oblong, white, film-coated tablet for oral administration
|
Placebo
n=3 participants at risk
For 7 days, and in addition to institutional standard of care, participants will take 1 placebo tablet in the morning, in the afternoon, and in the evening.
Placebo: Oral formulation matched to the oral varespladib tablet
|
|---|---|---|---|---|
|
Cardiac disorders
Hypotension
|
0.00%
0/5 • Treatment-emergent AEs were events that occurred or worsened on or after the first dose of study intervention and prior to the 30 days after last administration of study intervention. AEs were reported through 60 days after randomization.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent AEs were events that occurred or worsened on or after the first dose of study intervention and prior to the 30 days after last administration of study intervention. AEs were reported through 60 days after randomization.
|
0.00%
0/5 • Treatment-emergent AEs were events that occurred or worsened on or after the first dose of study intervention and prior to the 30 days after last administration of study intervention. AEs were reported through 60 days after randomization.
|
0.00%
0/3 • Treatment-emergent AEs were events that occurred or worsened on or after the first dose of study intervention and prior to the 30 days after last administration of study intervention. AEs were reported through 60 days after randomization.
|
|
Hepatobiliary disorders
Transaminases Increased
|
0.00%
0/5 • Treatment-emergent AEs were events that occurred or worsened on or after the first dose of study intervention and prior to the 30 days after last administration of study intervention. AEs were reported through 60 days after randomization.
|
20.0%
1/5 • Number of events 1 • Treatment-emergent AEs were events that occurred or worsened on or after the first dose of study intervention and prior to the 30 days after last administration of study intervention. AEs were reported through 60 days after randomization.
|
0.00%
0/5 • Treatment-emergent AEs were events that occurred or worsened on or after the first dose of study intervention and prior to the 30 days after last administration of study intervention. AEs were reported through 60 days after randomization.
|
0.00%
0/3 • Treatment-emergent AEs were events that occurred or worsened on or after the first dose of study intervention and prior to the 30 days after last administration of study intervention. AEs were reported through 60 days after randomization.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60