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NCT04369469 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia
A Phase 3 study, sponsored by Alexion Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 202
- Enrollment target
NCT04369469: Clinical Trial Phase 3 study, sponsored by Alexion Pharmaceuticals.
NCT04369469 is a Phase 3 study that was terminated before completion, run by Alexion Pharmaceuticals. The registered enrollment target is 202 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04369469, a Phase 3 study, was terminated before completion, sponsored by Alexion Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 202 participants
- Enrollment target
Study Summary
This study evaluated the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult participants with coronavirus disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Participants were randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the participants) or BSC alone (1/3 of the participants). BSC consisted of medical treatment and/or medical interventions per routine hospital practice.
Primary Outcome
Survival (based on all-cause mortality) in Participants in the ITT Population at Day 29 was analyzed. The result for the survival was estimated survival combined over all imputations.
Interventions
- BIOLOGICAL Ravulizumab
- OTHER BSC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2020-05-10 |
| Est. Completion | 2021-04-08 |
| Phase | Phase 3 |
Why NCT04369469 stopped before completion
NCT04369469 is an interventional study that assigns participants to a tested intervention. The registered 202 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 (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Ravulizumab is the first listed.
NCT04369469 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04369469 about?
NCT04369469 is a clinical study titled "Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia". This study evaluated the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult participants with coronavirus disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Participants were randomly assigned to receive rav...
What is the current status of trial NCT04369469?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 202 participants. The study started on 2020-05-10. Estimated completion is 2021-04-08.
What interventions are being tested in trial NCT04369469?
The interventions under investigation include: Ravulizumab (BIOLOGICAL), BSC (OTHER).
Who is sponsoring clinical trial NCT04369469?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04369469's enrollment target sits among peer trials
202 1353rd of 2000 higher than 648 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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