Study of Mavrilimumab (KPL-301) in Participants Hospitalized With Severe Corona Virus Disease 2019 (COVID-19) Pneumonia and Hyper-inflammation

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Interventional, randomized, double-blind, placebo-controlled study encompassing 2 development phases (Phase 2 and Phase 3).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kiniksa Pharmaceuticals, Ltd.
• Treatments: Mavrilimumab

Criteria

Key Inclusion Criteria:

• Subject (or legally authorized representative) is able and willing to provide informed consent, which includes compliance with study requirements and restrictions listed in the consent form

• Positive SARS-CoV-2 (2019-nCoV) test within 14 days prior to randomization

• Hospitalized for SARS-CoV-2

• Bilateral pneumonia on chest x-ray or computed tomography

• Clinical laboratory results indicative of hyper-inflammation

• Cohort 1: Receiving any form of oxygenation or NIV to maintain SpO2 ≥ 92% and not-intubated (examples include nasal cannula, face mask, venturi mask, high-flow nasal cannula, or non-invasive positive pressure ventilation)

• Cohort 2: Recently ventilated with mechanical ventilation prior to randomization

Key Exclusion Criteria:

• Onset of COVID-19 symptoms or positive COVID-19 test result > 14 days prior to randomization

• Hospitalized > 7 days prior to randomization

• Need for invasive mechanical ventilation (Only for Cohort 1)

• Need for ECMO

• Serious prior or concomitant illness that in the opinion of the Investigator precludes the subject from enrolling in the trial

• Recent treatment with cell-depleting biological therapies (eg, anti-CD20) within 12 months, non-cell-depleting biological therapies (such as anti-tumor necrosis factor [TNF], anakinra, anti-IL-6 receptor [eg, tocilizumab], or abatacept) within 8 weeks (or 5 half-lives, whichever is longer), treatment with alkylating agents within 12 weeks, treatment with cyclosporine A, azathioprine, cyclophosphamide, mycophenolate mofetil (MMF), or other immunosuppressant (except for corticosteroids) within 4 weeks prior to randomization

• Corrected QT interval Fridericia's formula (QTcF) on Screening electrocardiogram (ECG) ≥500 ms

• Enrolled in another investigational study of a medical intervention

• Life expectancy less than 48 hours

• Known human immunodeficiency virus infection (regardless of immunological status), known hepatitis B virus surface antigen positivity and/or anti-hepatitis C virus positivity