We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov 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. 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
Sponsor:
Information provided by (Responsible Party):
Durect

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Layout table for location information
United States, New Jersey
Site 03
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
Durect
Investigators
Layout table for investigator information
Study Director: Robert Gordon, MD CTI Clinical Trial and Consulting Services
  Study Documents (Full-Text)

Documents provided by Durect:
Study Protocol and Statistical Analysis Plan  [PDF] December 8, 2020

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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

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