COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04447404
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : January 11, 2021
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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021

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 [ Time Frame: Day 28 ]
    Free of mechanical ventilation, free of renal replacement therapy and free of acute liver failure

  2. Occurrence of serious adverse events following treatment [ Time Frame: Day 1 to Day 60 ]

Secondary Outcome Measures :
  1. Alive at days 28 and 60 [ Time Frame: Days 28 and 60 ]
  2. Alive and out of ICU [ Time Frame: Day 28 ]
  3. Alive and out of hospital [ Time Frame: Day 28 and Day 60 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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 identifier (NCT number): NCT04447404

Layout table for location contacts
Contact: Deborah Scott 408-777-1417
Contact: Julie Fergus 408-777-1417

Layout table for location information
United States, Illinois
Site 02 Recruiting
Chicago, Illinois, United States, 60612
United States, Michigan
Site 01 Recruiting
Detroit, Michigan, United States, 48202
United States, New Jersey
Site 03 Recruiting
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
Layout table for investigator information
Study Director: Robert Gordon, MD CTI Clinical Trial & Consulting Services
Layout table for additonal information
Responsible Party: Durect Identifier: NCT04447404    
Other Study ID Numbers: C928-020
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No