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)

Completed · Phase 2 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04351243

Run by

Kinevant Sciences GmbH

People needed

227

Starts

2020-04-15

Expected to finish

2021-04-01

Last updated by the study team

2021-12-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Subjects who have been treated with convalescent plasma (CP) prior to enrollment are eligible if the subject continues to meet all inclusion criteria at screening
• The use of investigational anti-viral treatment (e.g., remdesivir) is allowed if the subject continues to meet all inclusion criteria at screening
• Additional inclusion criteria are detailed in the protocol

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
• Additional exclusion criteria are detailed in the protocol.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.