Official Title
A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Safety and Efficacy of DUR-928 in Subjects Infected With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury
Brief Summary

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

Terminated
SARS-CoV-2

Drug: DUR-928

IV infusion

Drug: Placebo

IV infusion

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
United States
Locations

Site 03
Newark, New Jersey, United States

Robert Gordon, MD, Study Director
CTI Clinical Trial and Consulting Services

NCT Number