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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04447404
Recruitment Status : Terminated (low enrollment)
First Posted : June 25, 2020
Results First Posted : August 5, 2022
Last Update Posted : August 5, 2022
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Drug: DUR-928 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3:1 randomization DUR-928:placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 21, 2020
Actual Primary Completion Date : March 4, 2021
Actual Study Completion Date : March 4, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: DUR-928 Drug: DUR-928
IV infusion

Placebo Comparator: Placebo Drug: Placebo
IV infusion

Primary Outcome Measures :
  1. Composite Endpoint of Alive and Free of Organ Failure at Day 28 [ Time Frame: Day 28 ]
    Free of mechanical ventilation, free of renal replacement therapy and free of acute liver failure

Secondary Outcome Measures :
  1. Alive at Days 28 and 60 [ Time Frame: Day 28 and Day 60 ]
  2. Alive, Out of ICU, at Day 28 [ Time Frame: Day 28 ]
  3. Alive, Out of Hospital, at Days 28 and 60 [ Time Frame: Day 28 and Day 60 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04447404

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United States, New Jersey
Site 03
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
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Study Director: Robert Gordon, MD CTI Clinical Trial and Consulting Services
  Study Documents (Full-Text)

Documents provided by Durect:
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Responsible Party: Durect
ClinicalTrials.gov Identifier: NCT04447404    
Other Study ID Numbers: C928-020
First Posted: June 25, 2020    Key Record Dates
Results First Posted: August 5, 2022
Last Update Posted: August 5, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No