SARS-CoV-2Phase 2NCT04447404
DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury
A Phase 2 study testing DUR-928 in people with SARS-CoV-2, run by Durect at 1 site in United States.
Trial summary
Evaluate safety and efficacy of DUR-928 in treatment of acute organ failure in subjects infected with SARS-CoV-2 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- DUR-928
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2020to 4 Mar 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Evaluate safety and efficacy of DUR-928 in treatment of acute organ failure in subjects infected with SARS-CoV-2
- Conditions
- SARS-CoV-2
- Being tested
- DUR-928, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DUR-928Drug
IV infusion
PlaceboDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| DUR-928 | Experimental | Not described Receives: Drug: DUR-928 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 28
Secondary outcomes (3)
Alive at Days 28 and 60
Measured: Day 28 and Day 60
Alive, Out of ICU, at Day 28
Measured: Day 28
Alive, Out of Hospital, at Days 28 and 60
Measured: Day 28 and Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start21 Sep 2020
- Primary completion4 Mar 2021
- Study completion4 Mar 2021
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3:1 randomization DUR-928:placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Durect
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Gordon, MD, Study director, CTI Clinical Trial and Consulting Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447404
- Sponsor's protocol ID
- C928-020
- Status last verified
- Jul 2022
- First submitted
- 23 Jun 2020
- Last updated
- 5 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04447404
- Acronym / sponsor ID
- C928-020
- Conditions
- SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- DurectIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 4 Mar 2021 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Posted 5 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate safety and efficacy of DUR-928 in treatment of acute organ failure in subjects infected with SARS-CoV-2
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 3:1 randomization DUR-928:placebo
| Arm | Type | Receives |
|---|---|---|
| DUR-928 | Experimental | Drug: DUR-928 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DUR-928IV infusion | Drug | DUR-928 |
| PlaceboIV infusion | Drug | Placebo |
Primary outcome
Composite Endpoint of Alive and Free of Organ Failure at Day 28
Time frame: Day 28
Free of mechanical ventilation, free of renal replacement therapy and free of acute liver failure
3 secondary outcomes
Alive at Days 28 and 60
Time frame: Day 28 and Day 60
Alive, Out of ICU, at Day 28
Time frame: Day 28
Alive, Out of Hospital, at Days 28 and 60
Time frame: Day 28 and Day 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for SARS-CoV-2
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Gordon, MD study director
CTI Clinical Trial and Consulting Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DUR-928 in people with SARS-CoV-2, run by Durect at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Endpoint of Alive and Free of Organ Failure at Day 28 (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.