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NCT04447469 · ClinicalTrials.gov registry record · Phase 2
Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19) Pneumonia and Hyper-inflammation
A Phase 2 study, sponsored by Kiniksa Pharmaceuticals International.
- Completed
- Registry status
- Phase 2
- Development phase
- 814
- Enrollment target
NCT04447469: Completed Phase 2 study, sponsored by Kiniksa Pharmaceuticals International.
NCT04447469 is a Phase 2 study that has completed, run by Kiniksa Pharmaceuticals International. The registered enrollment target is 814 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (512% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04447469, a Phase 2 study, has completed, sponsored by Kiniksa Pharmaceuticals International.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 814 participants
- Enrollment target
Study Summary
Interventional, randomized, double-blind, placebo-controlled study encompassing 2 development phases (Phase 2 and Phase 3).
Primary Outcome
Mechanical ventilation is defined as invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Mechanical ventilation status was evaluated based on the National Institute of Allergy and Infectious Diseases (NIAID) clinical outcome 8-point ordinal scale. Participants whose clinical outcome met a NIAID score of 2 were considered as using mechanical ventilation. The NIAID score is an 8-point ordinal scale of clinical outcomes: 1=death; 2=hospitalized, on invasive mechani
Interventions
- OTHER Placebo
- DRUG mavrilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 814 participants |
| Start Date | 2020-07-28 |
| Est. Completion | 2022-01-14 |
| Phase | Phase 2 |
What the finished NCT04447469 record still lists
NCT04447469 is an interventional study that assigns participants to a tested intervention. The registered 814 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (512% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04447469 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04447469 about?
NCT04447469 is a clinical study titled "Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19) Pneumonia and Hyper-inflammation". Interventional, randomized, double-blind, placebo-controlled study encompassing 2 development phases (Phase 2 and Phase 3).
What is the current status of trial NCT04447469?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 814 participants. The study started on 2020-07-28. Estimated completion is 2022-01-14.
What interventions are being tested in trial NCT04447469?
The interventions under investigation include: Placebo (OTHER), mavrilimumab (DRUG).
Who is sponsoring clinical trial NCT04447469?
This trial is sponsored by Kiniksa Pharmaceuticals International, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04447469's enrollment target sits among peer trials
814 36th of 2000 higher than 1,965 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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