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

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

Study Overview

• Status: Terminated
• Conditions: SARS-CoV-2
• Intervention / Treatment: Drug: Placebo; Drug: DUR-928

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Site 03

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; IV infusion
Experimental: DUR-928	Drug: DUR-928; IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Durect
• Investigators: Study Director: Robert Gordon, MD, CTI Clinical Trial and Consulting Services

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Actual): March 4, 2021
• Study Completion (Actual): March 4, 2021

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: C928-020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No