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 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)
1 other identifier
interventional
227
1 country
33
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 covid19
Started Apr 2020
Typical duration for phase_2 covid19
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2020
CompletedStudy Start
First participant enrolled
April 15, 2020
CompletedFirst Posted
Study publicly available on registry
April 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedResults Posted
Study results publicly available
December 10, 2021
CompletedDecember 14, 2021
December 1, 2021
8 months
April 15, 2020
November 26, 2021
December 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Mortality
"Incidence" is defined as the percent of subjects that died by Day 43
Day 43
Secondary Outcomes (3)
Proportion of Subjects Who Are Alive and Not on Mechanical Ventilation
Day 29
Number of Ventilator-free Days
Baseline to Day 29
Time to Hospital Discharge
Baseline to Day 43
Study Arms (2)
Gimsilumab
EXPERIMENTALGimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8
Placebo
PLACEBO COMPARATORNormal saline on Day 1 Normal saline on Day 8
Interventions
Gimsilumab is a fully human monoclonal antibody (mAb).
Eligibility Criteria
You may qualify if:
- Male or non-pregnant female age ≥18 years, inclusive
- Subject (or legally authorized representative) is able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other approved clinical testing prior to randomization
- Radiographic evidence of bilateral infiltrates
- Subject requires high-flow oxygen or meets clinical classification for ARDS
- Elevated serum CRP or ferritin
You may not qualify if:
- Evidence of life-threatening dysrhythmia or cardiac arrest on presentation
- Intubated \>72 hours
- Absolute neutrophil count \< 1,000 per mm3
- Platelet count \< 50,000 per mm3
- AST or ALT \> 5X upper limit of normal
- eGFR \<30 mL/min/1.73m2 or requiring hemofiltration or dialysis
- History of known anti-GM-CSF autoantibodies or pulmonary alveolar proteinosis
- Severe chronic respiratory disease (e.g., COPD, PAH, IPF, ILD) requiring supplemental oxygen therapy or mechanical ventilation pre-hospitalization (e.g., prior to COVID-19 diagnosis)
- Use of any immunomodulatory biologic, cell therapy, or small molecule JAK inhibitor within past 7 days or 5 half lives or planned use of any of these agents unless approved by medical monitor
- Chronic (\>4 weeks) use of corticosteroids \>10mg/day of prednisone or equivalent
- Known or suspected active and untreated TB, HIV, hepatitis B or C infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kinevant Sciences GmbHlead
- Roivant Sciences, Inc.collaborator
Study Sites (33)
Banner University Medical Center
Phoenix, Arizona, 85006, United States
HonorHealth John C. Lincoln Medical Center
Phoenix, Arizona, 85020, United States
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona, 85251, United States
HonorHealth
Scottsdale, Arizona, 85258, United States
HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona, 85260, United States
Banner University Medical Center
Tucson, Arizona, 85719, United States
UCLA Ronald Reagan Medical Center
Los Angeles, California, 90095, United States
University of Florida
Gainesville, Florida, 32610, United States
Miami Cancer institute
Miami, Florida, 33176, United States
Piedmont Healthcare
Atlanta, Georgia, 30309, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
East Jefferson General Hospital
Metairie, Louisiana, 70006, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073, United States
Jamaica Hospital Medical Center
Jamaica, New York, 11418, United States
Mount Sinai Beth Israel
New York, New York, 10003, United States
Mount Sinai West
New York, New York, 10019, United States
Mount Sinai Morningside
New York, New York, 10025, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor Jack & Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, 75226, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Baylor Scott & White All Saints Medical Center
Fort Worth, Texas, 75061, United States
Memorial Hermann Hospital Affiliated with University of Texas Health Science Center at Houston, McGovern Medical School
Houston, Texas, 77030, United States
Baylor Scott & White Medical Center
Irving, Texas, 75061, United States
Baylor Scott & White Heart Hospital
Plano, Texas, 75093, United States
Baylor Scott & White Medical Center
Plano, Texas, 75093, United States
Baylor Scott & White Medical Center
Round Rock, Texas, 78665, United States
Baylor Scott & White Medical Center
Temple, Texas, 76508, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042, United States
Related Publications (1)
Criner GJ, Lang FM, Gottlieb RL, Mathews KS, Wang TS, Rice TW, Madduri D, Bellam S, Jeanfreau R, Case AH, Glassberg MK, Lyon GM, Ahmad K, Mendelson R, DiMaio JM, Tran MP, Spak CW, Abbasi JA, Davis SG, Ghamande S, Shen S, Sherman L, Lowry S. Anti-Granulocyte-Macrophage Colony-Stimulating Factor Monoclonal Antibody Gimsilumab for COVID-19 Pneumonia: A Randomized, Double-Blind, Placebo-controlled Trial. Am J Respir Crit Care Med. 2022 Jun 1;205(11):1290-1299. doi: 10.1164/rccm.202108-1859OC.
PMID: 35290169DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The Sponsor stopped enrollment of subjects prior to achieving the planned sample size of 270. At the completion of study enrollment, 227 subjects were randomized and 225 received at least one dose of gimsilumab or placebo. All randomized subjects (227 subjects), where possible, completed all study-related activities and had data collected through the planned Day 43 and Day 169 analyses. No safety findings were observed which warranted study termination.
Results Point of Contact
- Title
- Simon Lowry, MD, Chief Medical Officer
- Organization
- Kinevant Sciences, Inc. on behalf of Kinevant Sciences GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2020
First Posted
April 17, 2020
Study Start
April 15, 2020
Primary Completion
December 1, 2020
Study Completion
April 1, 2021
Last Updated
December 14, 2021
Results First Posted
December 10, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share