Official Title
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)
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.

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 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.

Completed
COVID-19

Drug: Gimsilumab

Gimsilumab is a fully human monoclonal antibody (mAb).
Other Name: KIN-1901

Drug: Placebo

Normal saline

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

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

Roivant Sciences, Inc.
NCT Number
Keywords
Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF)
Immunomodulator
Cytokine storm
Covid-19
Coronavirus
Severe Acute Respiratory Syndrome (SARS)
Lung Injury
monoclonal antibody
MeSH Terms
COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Lung Injury
Gimsilumab