DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury
- Registration Number
- NCT04447404
- Lead Sponsor
- Durect
- Brief Summary
Evaluate safety and efficacy of DUR-928 in treatment of acute organ failure in subjects infected with SARS-CoV-2
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DUR-928 DUR-928 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Alive at Days 28 and 60 Day 28 and Day 60 Alive, Out of Hospital, at Days 28 and 60 Day 28 and Day 60 Alive, Out of ICU, at Day 28 Day 28
Trial Locations
- Locations (1)
Site 03
🇺🇸Newark, New Jersey, United States