Study Stopped
low enrollment
DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury
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
1 other identifier
interventional
2
1 country
1
Brief Summary
Evaluate safety and efficacy of DUR-928 in treatment of acute organ failure in subjects infected with SARS-CoV-2
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2020
CompletedFirst Posted
Study publicly available on registry
June 25, 2020
CompletedStudy Start
First participant enrolled
September 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2021
CompletedResults Posted
Study results publicly available
August 5, 2022
CompletedAugust 5, 2022
July 1, 2022
5 months
June 23, 2020
June 10, 2022
July 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Composite Endpoint of Alive and Free of Organ Failure at Day 28
Free of mechanical ventilation, free of renal replacement therapy and free of acute liver failure
Day 28
Secondary Outcomes (3)
Alive at Days 28 and 60
Day 28 and Day 60
Alive, Out of ICU, at Day 28
Day 28
Alive, Out of Hospital, at Days 28 and 60
Day 28 and Day 60
Study Arms (2)
DUR-928
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Durectlead
Study Sites (1)
Site 03
Newark, New Jersey, 07103, United States
Limitations and Caveats
Early study termination led to small number (n=2) of subjects and in one treatment group.
Results Point of Contact
- Title
- Executive Director, Regulatory Affairs
- Organization
- DURECT Corporation
Study Officials
- STUDY DIRECTOR
Robert Gordon, MD
CTI Clinical Trial and Consulting Services
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2020
First Posted
June 25, 2020
Study Start
September 21, 2020
Primary Completion
March 4, 2021
Study Completion
March 4, 2021
Last Updated
August 5, 2022
Results First Posted
August 5, 2022
Record last verified: 2022-07