NCT04447404 is a Phase 2 clinical trial of DUR-928 in SARS-CoV-2, sponsored by Durect.

Who is sponsoring NCT04447404?

NCT04447404 is sponsored by Durect.

What drugs are being tested in NCT04447404?

Interventions in NCT04447404: DUR-928, Placebo.

What condition does NCT04447404 study?

NCT04447404 studies SARS-CoV-2.

Is NCT04447404 still recruiting?

NCT04447404 is currently terminated. Last updated 5 August 2022.

Are results published for NCT04447404?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-08-05 · How we verify

NCT04447404

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 2 Results posted Last updated 5 August 2022

What this trial tests

Phase 2 trial testing DUR-928 in SARS-CoV-2 in 2 participants. Terminated before completion.

Timeline

21 September 2020

Primary endpoint
4 March 2021

4 March 2021

Quick facts

Lead sponsor	Durect
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	2
Start date	21 September 2020
Primary completion	4 March 2021
Estimated completion	4 March 2021
Sites	1 location across United States

Drugs / interventions tested

DUR-928 — full drug profile →
Placebo

Conditions studied

SARS-CoV-2 — all drugs for SARS-CoV-2 →

Sponsor

Durect — full company profile →

Who can join

Adults 18 to 80, any sex, with SARS-CoV-2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Composite Endpoint of Alive and Free of Organ Failure at Day 28 Primary · Day 28

Free of mechanical ventilation, free of renal replacement therapy and free of acute liver failure

Group	Value	95% CI
DUR-928	0
Placebo	0

Alive at Days 28 and 60 Secondary · Day 28 and Day 60

Group	Value	95% CI
DUR-928	0
Placebo	0

Alive, Out of ICU, at Day 28 Secondary · Day 28

Group	Value	95% CI
DUR-928	0
Placebo	0

Alive, Out of Hospital, at Days 28 and 60 Secondary · Day 28 and Day 60

Group	Value	95% CI
DUR-928	0
Placebo	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 60 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

DUR-928

Serious: 2/2 (100%)

Deaths: 2/2

Placebo

Serious: 0

Deaths: 0

Serious adverse events (2 terms)

Reaction	System	DUR-928	Placebo
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Brain Injury	Nervous system disorders	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	DUR-928	Placebo
Pyrexia	General disorders	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—
Deep Vein Thrombosis	Vascular disorders	—	—
Hypotension	Vascular disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Bradycardia	Cardiac disorders	—	—
Activated Partial Thromboplastin Time Prolonged	Investigations	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—

Most-reported serious reactions: Respiratory failure, Brain Injury.

Data from ClinicalTrials.gov NCT04447404 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of DUR-928

Trials testing the same drug.

NCT03394781 — A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC) · Phase 2 · terminated

Other recruiting trials for SARS-CoV-2

Currently open trials in the same condition.

NCT07266558 — A Study to Evaluate the Efficacy and Safety of mRNA-1283 and mRNA-1273 in Participants 50 to 64 Years of Age Without Hig · Phase 4 · recruiting
NCT06684379 — Study on Safety and Efficacy of Two Doses of PRS CK STORM in the Modulation of the Cytokine Storm for the Treatment of A · Phase 1, PHASE2 · recruiting
NCT06585241 — A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Vaccine Formulations · Phase 4 · recruiting
NCT05876377 — Use and Effectiveness of COVID-19 Vaccines Using State Vaccine Registries and Insurance Claims Data · active not recruiting
NCT05799651 — Safety and Immunogenicity of Glycovax-002 Vaccine in Healthy Adults · Phase 1 · active not recruiting

Other Durect trials

Trials by the same sponsor.

NCT04563026 — A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment · Phase 2 · completed
NCT03837743 — Safety and Efficacy Study of DUR-928 Topical Solution in Subjects With Plaque Psoriasis · Phase 2 · completed
NCT03432260 — A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepat · Phase 2 · completed
NCT03394781 — A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC) · Phase 2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04447404 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Durect
Last refreshed: 5 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04447404.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing