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NCT04351243 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)
A Phase 2 study of COVID-19, sponsored by Kinevant Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 227
- Enrollment target
- 20
- Study locations
NCT04351243: Completed Phase 2 study of COVID-19, sponsored by Kinevant Sciences.
NCT04351243 is a Phase 2 study of COVID-19 that has completed, run by Kinevant Sciences. The registered enrollment target is 227 participants, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04351243, a Phase 2 study of COVID-19, has completed, sponsored by Kinevant Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 227 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study KIN-1901-2001 is a multi-center, adaptive, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of gimsilumab in subjects with lung injury or acute respiratory distress syndrome (ARDS) secondary to COVID-19.
Primary Outcome
"Incidence" is defined as the percent of subjects that died by Day 43
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Gimsilumab
Study Locations (20)
Arizona
- Banner University Medical Center - Phoenix
- HonorHealth John C. Lincoln Medical Center - Phoenix
- HonorHealth Scottsdale Osborn Medical Center - Scottsdale
- HonorHealth - Scottsdale
- HonorHealth Scottsdale Shea Medical Center - Scottsdale
- Banner University Medical Center - Tucson
New York
- Jamaica Hospital Medical Center - Jamaica
- Mount Sinai Beth Israel - New York
- Mount Sinai West - New York
- Mount Sinai Morningside - New York
- Icahn School of Medicine at Mount Sinai - New York
Florida
- University of Florida - Gainesville
- Miami Cancer institute - Miami
Georgia
- Piedmont Healthcare - Atlanta
- Emory University School of Medicine - Atlanta
California
- UCLA Ronald Reagan Medical Center - Los Angeles
Illinois
- NorthShore University HealthSystem - Evanston
Louisiana
- East Jefferson General Hospital - Metairie
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 227 participants |
| Start Date | 2020-04-15 |
| Est. Completion | 2021-04-01 |
| Phase | Phase 2 |
What the finished NCT04351243 record still lists
NCT04351243 is an interventional study that assigns participants to a tested intervention. The registered 227 participants enrollment target is mid-sized for trials with a published cap, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04351243 names 20 study sites across 9 states, led by Arizona, New York, Florida.
Frequently Asked Questions
What is clinical trial NCT04351243 about?
NCT04351243 is a clinical study titled "A Study to Assess the Efficacy and Safety of Gimsilumab in Subjects With Lung Injury or Acute Respiratory Distress Syndrome Secondary to COVID-19 (BREATHE)". Study KIN-1901-2001 is a multi-center, adaptive, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of gimsilumab in subjects with lung injury or acute respiratory distress syndrome (ARDS) secondary to COVID-19.
What is the current status of trial NCT04351243?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 227 participants. The study started on 2020-04-15. Estimated completion is 2021-04-01.
What conditions does trial NCT04351243 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT04351243?
The interventions under investigation include: Placebo (DRUG), Gimsilumab (DRUG).
Who is sponsoring clinical trial NCT04351243?
This trial is sponsored by Kinevant Sciences, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04351243 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for COVID-19
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04351243's enrollment target sits among peer trials
227 155th of 298 higher than 143 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 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.
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