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)
Public ClinicalTrials.gov record NCT04351243. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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 Secondary to COVID-19 (BREATHE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04351243
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 227 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 15, 2020 (Actual)
- Primary completion
- Dec 1, 2020 (Actual)
- Completion
- Apr 1, 2021 (Actual)
- Last update posted
- Dec 14, 2021
2020 – 2021
United States locations
- U.S. sites
- 33
- U.S. states
- 14
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner University Medical Center | Phoenix | Arizona | 85006 | — |
| HonorHealth John C. Lincoln Medical Center | Phoenix | Arizona | 85020 | — |
| HonorHealth Scottsdale Osborn Medical Center | Scottsdale | Arizona | 85251 | — |
| HonorHealth | Scottsdale | Arizona | 85258 | — |
| HonorHealth Scottsdale Shea Medical Center | Scottsdale | Arizona | 85260 | — |
| Banner University Medical Center | Tucson | Arizona | 85719 | — |
| UCLA Ronald Reagan Medical Center | Los Angeles | California | 90095 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| Miami Cancer institute | Miami | Florida | 33176 | — |
| Piedmont Healthcare | Atlanta | Georgia | 30309 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | — |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | — |
| East Jefferson General Hospital | Metairie | Louisiana | 70006 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Beaumont Hospital - Royal Oak | Royal Oak | Michigan | 48073 | — |
| Jamaica Hospital Medical Center | Jamaica | New York | 11418 | — |
| Mount Sinai Beth Israel | New York | New York | 10003 | — |
| Mount Sinai West | New York | New York | 10019 | — |
| Mount Sinai Morningside | New York | New York | 10025 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Baylor Jack & Jane Hamilton Heart and Vascular Hospital | Dallas | Texas | 75226 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| Baylor Scott & White All Saints Medical Center | Fort Worth | Texas | 75061 | — |
| Memorial Hermann Hospital Affiliated with University of Texas Health Science Center at Houston, McGovern Medical School | Houston | Texas | 77030 | — |
| Baylor Scott & White Medical Center | Irving | Texas | 75061 | — |
| Baylor Scott & White Heart Hospital | Plano | Texas | 75093 | — |
| Baylor Scott & White Medical Center | Plano | Texas | 75093 | — |
| Baylor Scott & White Medical Center | Round Rock | Texas | 78665 | — |
| Baylor Scott & White Medical Center | Temple | Texas | 76508 | — |
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04351243, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 14, 2021 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04351243 live on ClinicalTrials.gov.