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NCT04362813 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 454
- Enrollment target
NCT04362813: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT04362813 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 454 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04362813, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 454 participants
- Enrollment target
Study Summary
This was a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of canakinumab plus standard-of-care (SOC) compared with placebo plus SOC in patients with COVID-19-induced pneumonia and cytokine release syndrome (CRS).
Primary Outcome
Number of responders who survived without requiring invasive mechanical ventilation from Day 3 to Day 29. An early dropout without requiring invasive mechanical ventilation is considered as a responder if discharged from hospital with 9-point ordinal scale\<=1 or with last 9-point ordinal scale on/after Day 15 better than baseline.
Interventions
- DRUG Placebo
- DRUG Canakinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 454 participants |
| Start Date | 2020-04-30 |
| Est. Completion | 2020-12-22 |
| Phase | Phase 3 |
What the finished NCT04362813 record still lists
NCT04362813 is an interventional study that assigns participants to a tested intervention. The registered 454 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 (41% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04362813 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04362813 about?
NCT04362813 is a clinical study titled "Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia". This was a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of canakinumab plus standard-of-care (SOC) compared with placebo plus SOC in patients with COVID-19-induced pneumonia and cytokine release syndrome (CRS).
What is the current status of trial NCT04362813?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 454 participants. The study started on 2020-04-30. Estimated completion is 2020-12-22.
What interventions are being tested in trial NCT04362813?
The interventions under investigation include: Placebo (DRUG), Canakinumab (DRUG).
Who is sponsoring clinical trial NCT04362813?
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 NCT04362813's enrollment target sits among peer trials
454 831st of 2000 higher than 1,167 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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