Status:
TERMINATED
DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury
Lead Sponsor:
Durect
Conditions:
SARS-CoV-2
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Evaluate safety and efficacy of DUR-928 in treatment of acute organ failure in subjects infected with SARS-CoV-2
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04447404
Start Date
September 21 2020
End Date
March 4 2021
Last Update
August 5 2022
Active Locations (1)
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1
Site 03
Newark, New Jersey, United States, 07103