Status:
COMPLETED
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)
Lead Sponsor:
Kinevant Sciences GmbH
Collaborating Sponsors:
Roivant Sciences, Inc.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 di...
Detailed Description
Gimsilumab is a monoclonal antibody against granulocyte macrophage-colony stimulating factor (GM-CSF), which is a myeloid cell growth factor and pro- inflammatory cytokine. Late stages of COVID-19 can...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT04351243
Start Date
April 15 2020
End Date
April 1 2021
Last Update
December 14 2021
Active Locations (33)
Enter a location and click search to find clinical trials sorted by distance.
1
Banner University Medical Center
Phoenix, Arizona, United States, 85006
2
HonorHealth John C. Lincoln Medical Center
Phoenix, Arizona, United States, 85020
3
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona, United States, 85251
4
HonorHealth
Scottsdale, Arizona, United States, 85258