SARS-CoV-2
Conditions
Brief summary
Evaluate safety and efficacy of DUR-928 in treatment of acute organ failure in subjects infected with SARS-CoV-2
Interventions
DRUGDUR-928
IV infusion
DRUGPlacebo
IV infusion
Sponsors
Durect
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
3:1 randomization DUR-928:placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Hospitalized with moderate, severe, or early critical COVID-19 illness diagnosed by RT- PCR * Acute liver injury (including acute on chronic liver disease) or acute kidney injury or moderate COVID-19 pneumonia
Exclusion criteria
* Critical COVID-19 illness (MAP \< 60 mm Hg, on mechanical ventilator for ≥ 5 days) * On maintenance hemodialysis or peritoneal dialysis * Child Pugh C cirrhosis * Hepatorenal syndrome * Ascites and/or hepatic encephalopathy * History of end stage renal disease or CKD with eGFR \< 15 mL/min/1.73m2 * Women who are pregnant or breast feeding * Receipt of other concomitant experimental therapies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Endpoint of Alive and Free of Organ Failure at Day 28 | Day 28 | Free of mechanical ventilation, free of renal replacement therapy and free of acute liver failure |
Secondary
| Measure | Time frame |
|---|---|
| Alive at Days 28 and 60 | Day 28 and Day 60 |
| Alive, Out of ICU, at Day 28 | Day 28 |
| Alive, Out of Hospital, at Days 28 and 60 | Day 28 and Day 60 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DUR-928 DUR-928: IV infusion | 2 |
| Placebo Placebo: IV infusion | 0 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | DUR-928 |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Continuous | — | 66.5 years STANDARD_DEVIATION 16.26 | 66.5 years STANDARD_DEVIATION 16.26 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 2 | 0 / 0 |
| other Total, other adverse events | 2 / 2 | 0 / 0 |
| serious Total, serious adverse events | 2 / 2 | 0 / 0 |
Outcome results
Primary
Composite Endpoint of Alive and Free of Organ Failure at Day 28
Free of mechanical ventilation, free of renal replacement therapy and free of acute liver failure
Time frame: Day 28
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DUR-928 | Composite Endpoint of Alive and Free of Organ Failure at Day 28 | 0 Participants |
| Placebo | Composite Endpoint of Alive and Free of Organ Failure at Day 28 | 0 Participants |
Secondary
Alive at Days 28 and 60
Time frame: Day 28 and Day 60
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DUR-928 | Alive at Days 28 and 60 | 0 Participants |
| Placebo | Alive at Days 28 and 60 | 0 Participants |
Secondary
Alive, Out of Hospital, at Days 28 and 60
Time frame: Day 28 and Day 60
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DUR-928 | Alive, Out of Hospital, at Days 28 and 60 | 0 Participants |
| Placebo | Alive, Out of Hospital, at Days 28 and 60 | 0 Participants |
Secondary
Alive, Out of ICU, at Day 28
Time frame: Day 28
Population: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DUR-928 | Alive, Out of ICU, at Day 28 | 0 Participants |
| Placebo | Alive, Out of ICU, at Day 28 | 0 Participants |