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)

• Status: Completed
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kinevant Sciences GmbH
• Collaborator: Roivant Sciences, Inc.
• Treatments: Gimsilumab

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 prior to enrollment are eligible if the subject continues to meet all entry criteria at screening

8. The use of investigational antiviral treatments (e.g., remdesivir, hydroxychloroquine) is allowed during the study

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. Known or suspected active and untreated TB, HIV, hepatitis B or C infection

Additional exclusion criteria are detailed in the protocol.