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DUR-928 in Subjects With SARS-CoV-2 With Acute 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.
 
ClinicalTrials.gov Identifier: NCT04447404
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Durect

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)
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 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

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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
Criteria

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

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


Contacts
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Contact: Deborah Scott 408-777-1417 deborah.scott@durect.com
Contact: Julie Fergus 408-777-1417 julie.fergus@durect.com

Locations
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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
Durect
Investigators
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Study Director: Robert Gordon, MD CTI Clinical Trial & Consulting Services
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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
Last Update Posted: September 30, 2020
Last Verified: September 2020

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