DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury

• Status: Terminated
• Trial end date: 2021-03-04
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate safety and efficacy of DUR-928 in treatment of acute organ failure in subjects infected with SARS-CoV-2

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Durect

Criteria

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