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NCT04363437 · ClinicalTrials.gov registry record · Phase 2
COlchicine in Moderate-severe Hospitalized Patients Before ARDS to Treat COVID-19
A Phase 2 study, sponsored by Maimonides Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT04363437: Clinical Trial Phase 2 study, sponsored by Maimonides Medical Center.
NCT04363437 is a Phase 2 study that was terminated before completion, run by Maimonides Medical Center. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04363437, a Phase 2 study, was terminated before completion, sponsored by Maimonides Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
The most prevalent complication of COVID-19 infection is respiratory failure from severe acute respiratory syndrome (SARS), the leading cause of mortality. There is increasing indication that the decompensation in severe COVD-19 infection may be due to a cytokine storm syndrome. This hyperinflammatory syndrome results in a fulminant and fatal hypercytokinemia and multiorgan failure. Approximately 15% of patients with COVID-19 infection are hospitalized and 20-30% of these hospitalized patients require ICU care and/or mechanical ventilation. Overall mortality in hospitalized patients is approximately 20-25%. There is significant interest in therapies that can be given upstream to reduce the rate of mechanical ventilation and thus mortality. We hypothesize that treatment with colchicine in COVID-19 moderate-severe patients may decrease the risk of progression into ARDS requiring increased oxygen requirements, mechanical ventilation, and mortality.
Interventions
- DRUG Colchicine
- DRUG Usual Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2020-04-26 |
| Est. Completion | 2020-07-31 |
| Phase | Phase 2 |
Why NCT04363437 stopped before completion
NCT04363437 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Colchicine is the first listed.
NCT04363437 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04363437 about?
NCT04363437 is a clinical study titled "COlchicine in Moderate-severe Hospitalized Patients Before ARDS to Treat COVID-19". The most prevalent complication of COVID-19 infection is respiratory failure from severe acute respiratory syndrome (SARS), the leading cause of mortality. There is increasing indication that the decompensation in severe COVD-19 infection may be due to a cytokine storm syndrome. This hyperinflammato...
What is the current status of trial NCT04363437?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2020-04-26. Estimated completion is 2020-07-31.
What interventions are being tested in trial NCT04363437?
The interventions under investigation include: Colchicine (DRUG), Usual Care (DRUG).
Who is sponsoring clinical trial NCT04363437?
This trial is sponsored by Maimonides Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04363437's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 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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