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)
Condition: COVID-19
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
Intervention: Gimsilumab; Placebo
Intervention description: Gimsilumab is a fully human monoclonal antibody (mAb).; Normal saline
Intervention MeSH terms: Gimsilumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 227.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Granulocyte macrophage-colony stimulating factor (GM-CSF); Immunomodulator; Cytokine storm; COVID-19; Coronavirus; Severe Acute Respiratory Syndrome (SARS); Lung Injury; Monoclonal antibody

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.
    

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.