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)
NCT ID: NCT04351243
Last Updated: 2021-12-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
227 participants
INTERVENTIONAL
2020-04-15
2021-04-01
Brief Summary
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Detailed Description
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Study KIN-1901-2001 will consist of a 2-week treatment period (last dose Day 8, if administered) and a 22-week follow-up period, for a total study duration of 24 weeks for each subject. A total of 270 subjects (135 subjects per arm) who have a confirmed diagnosis of COVID-19 with clinical evidence of acute lung injury or ARDS will be entered into the trial.
Subjects will receive a 400 mg dose of gimsilumab on Day 1 and a 200 mg dose of gimsilumab on Day 8, or matching placebo (saline solution) on Day 1 and on Day 8. The Day 8 dose will be omitted if the subject is discharged from the hospital prior to the dose or is no longer in need of supplemental oxygen or ventilatory support for \>48 hours.
The primary objective of Study KIN-1901-2001 is to evaluate the impact of IV treatment with gimsilumab on mortality in subjects with lung injury or ARDS secondary to COVID-19.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Gimsilumab
Gimsilumab 400 mg on Day 1 Gimsilumab 200 mg on Day 8
Gimsilumab
Gimsilumab is a fully human monoclonal antibody (mAb).
Placebo
Normal saline on Day 1 Normal saline on Day 8
Placebo
Normal saline
Interventions
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Gimsilumab
Gimsilumab is a fully human monoclonal antibody (mAb).
Placebo
Normal saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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
3. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other approved clinical testing prior to randomization
4. Radiographic evidence of bilateral infiltrates
5. Subject requires high-flow oxygen or meets clinical classification for ARDS
6. Elevated serum CRP or ferritin
Exclusion Criteria
2. Intubated \>72 hours
3. Absolute neutrophil count \< 1,000 per mm3
4. Platelet count \< 50,000 per mm3
5. AST or ALT \> 5X upper limit of normal
6. eGFR \<30 mL/min/1.73m2 or requiring hemofiltration or dialysis
7. History of known anti-GM-CSF autoantibodies or pulmonary alveolar proteinosis
8. 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)
9. 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
10. Chronic (\>4 weeks) use of corticosteroids \>10mg/day of prednisone or equivalent
11. Known or suspected active and untreated TB, HIV, hepatitis B or C infection
18 Years
ALL
No
Sponsors
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Roivant Sciences, Inc.
INDUSTRY
Kinevant Sciences GmbH
INDUSTRY
Responsible Party
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Locations
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Banner University Medical Center
Phoenix, Arizona, United States
HonorHealth John C. Lincoln Medical Center
Phoenix, Arizona, United States
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona, United States
HonorHealth
Scottsdale, Arizona, United States
HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona, United States
Banner University Medical Center
Tucson, Arizona, United States
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States
University of Florida
Gainesville, Florida, United States
Miami Cancer institute
Miami, Florida, United States
Piedmont Healthcare
Atlanta, Georgia, United States
Emory University School of Medicine
Atlanta, Georgia, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
East Jefferson General Hospital
Metairie, Louisiana, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States
Jamaica Hospital Medical Center
Jamaica, New York, United States
Mount Sinai Beth Israel
New York, New York, United States
Mount Sinai West
New York, New York, United States
Mount Sinai Morningside
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor Jack & Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
Baylor Scott & White All Saints Medical Center
Fort Worth, Texas, United States
Memorial Hermann Hospital Affiliated with University of Texas Health Science Center at Houston, McGovern Medical School
Houston, Texas, United States
Baylor Scott & White Medical Center
Irving, Texas, United States
Baylor Scott & White Heart Hospital
Plano, Texas, United States
Baylor Scott & White Medical Center
Plano, Texas, United States
Baylor Scott & White Medical Center
Round Rock, Texas, United States
Baylor Scott & White Medical Center
Temple, Texas, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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KIN-1901-2001
Identifier Type: -
Identifier Source: org_study_id