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

• DUR-928 (Drug): IV infusion
• Placebo (Drug): IV infusion

Primary outcomes

• 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 outcomes

• Alive at Days 28 and 60 [Day 28 and Day 60]
• Alive, Out of ICU, at Day 28 [Day 28]
• Alive, Out of Hospital, at Days 28 and 60 [Day 28 and Day 60]

Sex: All, ages: 18 Years to 80 Years

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

Participant flow

Outcome results

• Composite Endpoint of Alive and Free of Organ Failure at Day 28 (Primary), Count of participants, Participants: DUR-928 0; Placebo 0
• Alive at Days 28 and 60 (Secondary), Count of participants, Participants: DUR-928 0; Placebo 0
• Alive, Out of ICU, at Day 28 (Secondary), Count of participants, Participants: DUR-928 0; Placebo 0
• Alive, Out of Hospital, at Days 28 and 60 (Secondary), Count of participants, Participants: DUR-928 0; Placebo 0

Adverse events

Time frame: 60 days

Serious adverse events by term

Other adverse events by term

Limitations and caveats: Early study termination led to small number (n=2) of subjects and in one treatment group.

• Study Protocol and Statistical Analysis Plan (PDF, 2020-12-08)

• Robert Gordon, MD, Study director, CTI Clinical Trial and Consulting Services