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

  • STATUS
    Recruiting
  • participants needed
    80
  • sponsor
    Durect
Updated on 1 February 2023
organ failure
liver disease
SARS
kidney injury
acute respiratory syndrome (sars)

Summary

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

Details
Condition SARS-CoV 2
Age 18years - 80years
Treatment Placebo, DUR-928
Clinical Study IdentifierNCT04447404
SponsorDurect
Last Modified on1 February 2023

Eligibility

Yes No Not Sure

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

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
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