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

• Sponsor: Durect (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT04447404
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 3:1 randomization DUR-928:placebo3:1 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: Sep 21, 2020
• Actual Primary Completion Date: Mar 4, 2021
• Actual Study Completion Date: Mar 4, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Composite Endpoint of Alive and Free of Organ Failure at Day 28 [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 [Day 28 and Day 60]

2. Alive, Out of ICU, at Day 28 [Day 28]

3. Alive, Out of Hospital, at Days 28 and 60 [Day 28 and Day 60]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Site 03	Newark	New Jersey	United States	07103

Sponsors and Collaborators

• Durect

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 8, 2020

More Information

Publications

None provided.

• Responsible Party: Durect
• ClinicalTrials.gov Identifier: NCT04447404
• Other Study ID Numbers: C928-020
• First Posted: Jun 25, 2020
• Last Update Posted: Aug 5, 2022
• Last Verified: Jul 1, 2022

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

Study Results

Participant Flow

Arm/Group Title	DUR-928	Placebo
Arm/Group Description	DUR-928: IV infusion	Placebo: IV infusion
Period Title: Overall Study
STARTED	2	0
COMPLETED	0	0
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	DUR-928	Placebo	Total
Arm/Group Description	DUR-928: IV infusion	Placebo: IV infusion	Total of all reporting groups
Overall Participants	2	0	2
Age (Count of Participants)
<=18 years	0 0%	0 NaN	0 0%
Between 18 and 65 years	1 50%	0 NaN	1 50%
>=65 years	1 50%	0 NaN	1 50%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.5 (16.26)	66.5 (16.26)
Sex: Female, Male (Count of Participants)
Female	2 100%	0 NaN	2 100%
Male	0 0%	0 NaN	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 100%	0 NaN	2 100%
Not Hispanic or Latino	0 0%	0 NaN	0 0%
Unknown or Not Reported	0 0%	0 NaN	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 NaN	0 0%
Asian	0 0%	0 NaN	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 NaN	0 0%
Black or African American	0 0%	0 NaN	0 0%
White	2 100%	0 NaN	2 100%
More than one race	0 0%	0 NaN	0 0%
Unknown or Not Reported	0 0%	0 NaN	0 0%

Outcome Measures

1. Primary Outcome

Title	Composite Endpoint of Alive and Free of Organ Failure at Day 28
Description	Free of mechanical ventilation, free of renal replacement therapy and free of acute liver failure
Time Frame	Day 28

Outcome Measure Data

Analysis Population Description

Study was terminated early with only 2 subjects enrolled, both assigned to active treatment. Both subject deaths were assessed as Not Related to study treatment occurring on Day 19 and Day 20 (15 and 16 days after last dose, respectively).

Arm/Group Title	DUR-928	Placebo
Arm/Group Description	DUR-928: IV infusion	Placebo: IV infusion
Measure Participants	2	0
Count of Participants [Participants]	0 0%	0 NaN

2. Secondary Outcome

Title	Alive at Days 28 and 60
Time Frame	Day 28 and Day 60

Outcome Measure Data

Analysis Population Description

Study was terminated early with only 2 subjects enrolled, both assigned to active treatment. Both subject deaths were assessed as Not Related to study treatment occurring on Day 19 and Day 20 (15 and 16 days after last dose, respectively).

Arm/Group Title	DUR-928	Placebo
Arm/Group Description	DUR-928: IV infusion	Placebo: IV infusion
Measure Participants	2	0
Count of Participants [Participants]	0 0%	0 NaN

3. Secondary Outcome

Title	Alive, Out of ICU, at Day 28
Time Frame	Day 28

Outcome Measure Data

Analysis Population Description

Study was terminated early with only 2 subjects enrolled, both assigned to active treatment. Both subject deaths were assessed as Not Related to study treatment occurring on Day 19 and Day 20 (15 and 16 days after last dose, respectively).

Arm/Group Title	DUR-928	Placebo
Arm/Group Description	DUR-928: IV infusion	Placebo: IV infusion
Measure Participants	2	0
Count of Participants [Participants]	0 0%	0 NaN

4. Secondary Outcome

Title	Alive, Out of Hospital, at Days 28 and 60
Time Frame	Day 28 and Day 60

Outcome Measure Data

Analysis Population Description

Study was terminated early with only 2 subjects enrolled, both assigned to active treatment. Both subject deaths were assessed as Not Related to study treatment occurring on Day 19 and Day 20 (15 and 16 days after last dose, respectively).

Arm/Group Title	DUR-928	Placebo
Arm/Group Description	DUR-928: IV infusion	Placebo: IV infusion
Measure Participants	2	0
Count of Participants [Participants]	0 0%	0 NaN

Adverse Events

Time Frame	60 days
Adverse Event Reporting Description	Due to early study termination, no subjects were enrolled in the placebo treatment group.
Arm/Group Title	DUR-928		Placebo
Arm/Group Description	DUR-928: IV infusion		Placebo: IV infusion
All Cause Mortality
	DUR-928		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/2 (100%)		0/0 (NaN)
Serious Adverse Events
	DUR-928		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/2 (100%)		0/0 (NaN)
Nervous system disorders
Brain Injury	1/2 (50%)	1	0/0 (NaN)	1
Respiratory, thoracic and mediastinal disorders
Respiratory failure	1/2 (50%)	1	0/0 (NaN)	1
Other (Not Including Serious) Adverse Events
	DUR-928		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/2 (100%)		0/0 (NaN)
Blood and lymphatic system disorders
Anaemia	1/2 (50%)	1	0/0 (NaN)	1
Cardiac disorders
Bradycardia	1/2 (50%)	1	0/0 (NaN)	1
General disorders
Pyrexia	2/2 (100%)	3	0/0 (NaN)	3
Investigations
Activated Partial Thromboplastin Time Prolonged	1/2 (50%)	1	0/0 (NaN)	1
Metabolism and nutrition disorders
Hyperkalaemia	2/2 (100%)	2	0/0 (NaN)	2
Hypokalaemia	1/2 (50%)	1	0/0 (NaN)	1
Hyponatraemia	1/2 (50%)	1	0/0 (NaN)	1
Vascular disorders
Deep Vein Thrombosis	2/2 (100%)	2	0/0 (NaN)	2
Hypotension	2/2 (100%)	2	0/0 (NaN)	2

Limitations/Caveats

Early study termination led to small number (n=2) of subjects and in one treatment group.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The disclosure restriction on the PI is that if sponsor has not submitted a multi-site publication within 18 months of study completion, the PI can submit the sponsor results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The PI will remove confidential information from results communications prior to publication upon request.