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NCT04362137 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 432
- Enrollment target
NCT04362137: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT04362137 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 432 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04362137, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 432 participants
- Enrollment target
Study Summary
This was a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with placebo + SoC therapy, in patients aged ≥12 years with COVID-19 disease.
Primary Outcome
Efficacy is measured by a composite endpoint of proportion of patients who die, develop respiratory failure \[require mechanical ventilation\], or require intensive care unit \[ICU\] care for the treatment of COVID-19. Analyses are cumulative, thus analysis on Day 29 includes all events till that day. Patients who developed respiratory failure and/or required ICU at randomization are excluded from the analysis.
Interventions
- DRUG Placebo
- DRUG Ruxolitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 432 participants |
| Start Date | 2020-05-02 |
| Est. Completion | 2020-10-17 |
| Phase | Phase 3 |
What the finished NCT04362137 record still lists
NCT04362137 is an interventional study that assigns participants to a tested intervention. The registered 432 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 (44% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04362137 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04362137 about?
NCT04362137 is a clinical study titled "Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm". This was a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with placebo + SoC therapy, in patients aged ≥12 years with COVID-19 disease.
What is the current status of trial NCT04362137?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 432 participants. The study started on 2020-05-02. Estimated completion is 2020-10-17.
What interventions are being tested in trial NCT04362137?
The interventions under investigation include: Placebo (DRUG), Ruxolitinib (DRUG).
Who is sponsoring clinical trial NCT04362137?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04362137's enrollment target sits among peer trials
432 876th of 2000 higher than 1,124 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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