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

Durect

Status and phase: Terminated; Phase 2

Conditions: SARS-CoV-2

Treatments: Drug: DUR-928; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04447404

C928-020

Details and patient eligibility

About

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

Enrollment: 2 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2 participants in 2 patient groups, including a placebo group

DUR-928

Experimental group

Treatment:

Drug: DUR-928

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo