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NCT04472611 · ClinicalTrials.gov registry record · Phase 3
Colchicine/Statins for the Prevention of COVID-19 Complications (COLSTAT) Trial
A Phase 3 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 3
- Development phase
- 250
- Enrollment target
NCT04472611: Completed Phase 3 study, sponsored by Yale University.
NCT04472611 is a Phase 3 study that has completed, run by Yale University. The registered enrollment target is 250 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04472611, a Phase 3 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 250 participants
- Enrollment target
Study Summary
This is a pragmatic randomized open-label study of the safety and efficacy of the combination of colchicine and Rosuvastatin in addition to standard of care (SOC) compared to SOC alone in hospitalized patients with SARS-CoV-2
Primary Outcome
As defined by World Health Organization Ordinal Scale, which ranges from 1 to 8. Severity of COVID measured by WHO Scores 5-8: Defined as 5= Hospitalized requiring including CPAP, face mask, high flow nasal cannula (Excludes regular nasal cannula), 6= Hospitalized requiring intubation and mechanical ventilation, 7= Hospitalized requiring mechanical ventilation and additional organ support (vasopressors, renal replacement therapy, ECMO), 8= Death. Data presented is for Max WHO scores 5-8, indicat
Interventions
- DRUG Standard of Care (SOC) and Colchicine+Rosuvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2020-10-30 |
| Est. Completion | 2022-03-30 |
| Phase | Phase 3 |
What the finished NCT04472611 record still lists
NCT04472611 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which Standard of Care (SOC) and Colchicine+Rosuvastatin is the first listed.
NCT04472611 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04472611 about?
NCT04472611 is a clinical study titled "Colchicine/Statins for the Prevention of COVID-19 Complications (COLSTAT) Trial". This is a pragmatic randomized open-label study of the safety and efficacy of the combination of colchicine and Rosuvastatin in addition to standard of care (SOC) compared to SOC alone in hospitalized patients with SARS-CoV-2
What is the current status of trial NCT04472611?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2020-10-30. Estimated completion is 2022-03-30.
What interventions are being tested in trial NCT04472611?
The interventions under investigation include: Standard of Care (SOC) and Colchicine+Rosuvastatin (DRUG).
Who is sponsoring clinical trial NCT04472611?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04472611's enrollment target sits among peer trials
250 1249th of 2000 higher than 735 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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