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.
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 be marked by a "cytokine storm" and the overactivation of inflammatory
myeloid cells that infiltrate and damage tissue, such as the lungs. Inhibition of GM-CSF may
be able to reverse this pathology. The anti-GM-CSF mechanism is distinct from antiviral
therapeutic mechanisms and may provide synergistic effects when used in combination.
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.
Drug: Gimsilumab
Gimsilumab is a fully human monoclonal antibody (mAb).
Other Name: KIN-1901
Drug: Placebo
Normal saline
Inclusion Criteria:
1. Male or non-pregnant female age ≥18 years, inclusive
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
7. 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
8. 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 Criteria:
1. Evidence of life-threatening dysrhythmia or cardiac arrest on presentation
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
Additional exclusion criteria are detailed in the protocol.
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