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NCT04365985 · ClinicalTrials.gov registry record · Phase 2
Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19
A Phase 2 study, sponsored by Corewell Health East.
- Terminated
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
NCT04365985: Clinical Trial Phase 2 study, sponsored by Corewell Health East.
NCT04365985 is a Phase 2 study that was terminated before completion, run by Corewell Health East. The registered enrollment target is 70 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04365985, a Phase 2 study, was terminated before completion, sponsored by Corewell Health East.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
Study Summary
Ideal new treatments for Novel Coronavirus-19 (COVID-19) would help halt the progression disease in patients with mild disease prior to the need for artificial respiration (ventilators), and also provide a rescue treatment for patients with severe disease, while also being affordable and available in quantities sufficient to treat large numbers of infected people. Low doses of Naltrexone, a drug approved for treating alcoholism and opiate addiction, as well as Ketamine, a drug approved as an anesthetic, may be able to interrupt the inflammation that causes the worst COVID-19 symptoms and prove an effective new treatment. This study will investigate their effectiveness in a randomized, blinded trial versus standard treatment plus placebo.
Primary Outcome
Count of participants initially presenting with mild/moderate disease who progress to requiring advanced oxygenation (high flow nasal canula, non-rebreather, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or intubation)
Interventions
- OTHER Placebo
- DRUG Ketamine
- DRUG Naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2020-04-29 |
| Est. Completion | 2021-04-01 |
| Phase | Phase 2 |
Why NCT04365985 stopped before completion
NCT04365985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04365985 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04365985 about?
NCT04365985 is a clinical study titled "Study of Immunomodulation Using Naltrexone and Ketamine for COVID-19". Ideal new treatments for Novel Coronavirus-19 (COVID-19) would help halt the progression disease in patients with mild disease prior to the need for artificial respiration (ventilators), and also provide a rescue treatment for patients with severe disease, while also being affordable and available i...
What is the current status of trial NCT04365985?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2020-04-29. Estimated completion is 2021-04-01.
What interventions are being tested in trial NCT04365985?
The interventions under investigation include: Placebo (OTHER), Ketamine (DRUG), Naltrexone (DRUG).
Who is sponsoring clinical trial NCT04365985?
This trial is sponsored by Corewell Health East, which has 106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04365985's enrollment target sits among peer trials
70 937th of 2000 higher than 1,036 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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