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

SARS-CoV-2 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04447404
• Other study ID #: C928-020
• Status: Terminated
• Phase: Phase 2
• Start date: September 21, 2020
• Est. completion date: March 4, 2021

Study information

• Verified date: July 2022
• Source: Durect
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 4, 2021
• Est. primary completion date: March 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

Drug:
• DUR-928
IV infusion
• Placebo
IV infusion

Locations

Country	Name	City	State
United States	Site 03	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Durect

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Alive at Days 28 and 60		Day 28 and Day 60
Secondary	Alive, Out of ICU, at Day 28		Day 28
Secondary	Alive, Out of Hospital, at Days 28 and 60		Day 28 and Day 60