Trial Outcomes & Findings for DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury (NCT NCT04447404)
NCT ID: NCT04447404
Last Updated: 2022-08-05
Results Overview
Free of mechanical ventilation, free of renal replacement therapy and free of acute liver failure
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
Day 28
Results posted on
2022-08-05
Participant Flow
Participant milestones
| Measure |
DUR-928
DUR-928: IV infusion
|
Placebo
Placebo: IV infusion
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
DUR-928
DUR-928: IV infusion
|
Placebo
Placebo: IV infusion
|
|---|---|---|
|
Overall Study
Death
|
2
|
0
|
Baseline Characteristics
DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury
Baseline characteristics by cohort
| Measure |
DUR-928
n=2 Participants
DUR-928: IV infusion
|
Placebo
Placebo: IV infusion
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
66.5 years
STANDARD_DEVIATION 16.26 • n=5 Participants
|
—
|
66.5 years
STANDARD_DEVIATION 16.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: Study was terminated early with only 2 subjects enrolled, both assigned to active treatment. Both subject deaths were assessed as Not Related to study treatment occurring on Day 19 and Day 20 (15 and 16 days after last dose, respectively).
Free of mechanical ventilation, free of renal replacement therapy and free of acute liver failure
Outcome measures
| Measure |
DUR-928
n=2 Participants
DUR-928: IV infusion
|
Placebo
Placebo: IV infusion
|
|---|---|---|
|
Composite Endpoint of Alive and Free of Organ Failure at Day 28
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28 and Day 60Population: Study was terminated early with only 2 subjects enrolled, both assigned to active treatment. Both subject deaths were assessed as Not Related to study treatment occurring on Day 19 and Day 20 (15 and 16 days after last dose, respectively).
Outcome measures
| Measure |
DUR-928
n=2 Participants
DUR-928: IV infusion
|
Placebo
Placebo: IV infusion
|
|---|---|---|
|
Alive at Days 28 and 60
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Study was terminated early with only 2 subjects enrolled, both assigned to active treatment. Both subject deaths were assessed as Not Related to study treatment occurring on Day 19 and Day 20 (15 and 16 days after last dose, respectively).
Outcome measures
| Measure |
DUR-928
n=2 Participants
DUR-928: IV infusion
|
Placebo
Placebo: IV infusion
|
|---|---|---|
|
Alive, Out of ICU, at Day 28
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28 and Day 60Population: Study was terminated early with only 2 subjects enrolled, both assigned to active treatment. Both subject deaths were assessed as Not Related to study treatment occurring on Day 19 and Day 20 (15 and 16 days after last dose, respectively).
Outcome measures
| Measure |
DUR-928
n=2 Participants
DUR-928: IV infusion
|
Placebo
Placebo: IV infusion
|
|---|---|---|
|
Alive, Out of Hospital, at Days 28 and 60
|
0 Participants
|
0 Participants
|
Adverse Events
DUR-928
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DUR-928
n=2 participants at risk
DUR-928: IV infusion
|
Placebo
Placebo: IV infusion
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
50.0%
1/2 • Number of events 1 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
—
0/0 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
|
Nervous system disorders
Brain Injury
|
50.0%
1/2 • Number of events 1 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
—
0/0 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
Other adverse events
| Measure |
DUR-928
n=2 participants at risk
DUR-928: IV infusion
|
Placebo
Placebo: IV infusion
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
1/2 • Number of events 1 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
—
0/0 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
|
Cardiac disorders
Bradycardia
|
50.0%
1/2 • Number of events 1 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
—
0/0 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
|
General disorders
Pyrexia
|
100.0%
2/2 • Number of events 3 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
—
0/0 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
50.0%
1/2 • Number of events 1 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
—
0/0 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
100.0%
2/2 • Number of events 2 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
—
0/0 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
1/2 • Number of events 1 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
—
0/0 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
50.0%
1/2 • Number of events 1 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
—
0/0 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
|
Vascular disorders
Deep Vein Thrombosis
|
100.0%
2/2 • Number of events 2 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
—
0/0 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
|
Vascular disorders
Hypotension
|
100.0%
2/2 • Number of events 2 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
—
0/0 • 60 days
Due to early study termination, no subjects were enrolled in the placebo treatment group.
|
Additional Information
Executive Director, Regulatory Affairs
DURECT Corporation
Phone: 408-777-1417
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restriction on the PI is that if sponsor has not submitted a multi-site publication within 18 months of study completion, the PI can submit the sponsor results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The PI will remove confidential information from results communications prior to publication upon request.
- Publication restrictions are in place
Restriction type: OTHER