Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation
NCT04399980 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2021-05-13
Summary
The purpose of this prospective, Phase 2, multicenter, blinded, randomized placebo controlled study is to demonstrate that early treatment with mavrilimumab prevents progression of respiratory failure in patients with severe COVID-19 pneumonia and clinical and biological features of hyper-inflammation.
Conditions
- COVID 19
- SARS-CoV 2
- Pneumonia
Interventions
- DRUG
-
Mavrilimumab
Treatment infusion
- DRUG
-
Placebos
Placebo infusion
Sponsors & Collaborators
-
Kiniksa Pharmaceuticals, Ltd.
collaborator INDUSTRY -
The Cleveland Clinic
lead OTHER
Principal Investigators
-
Paul C Cremer, M. D. · The Cleveland Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-05-20
- Primary Completion
- 2021-04-23
- Completion
- 2021-04-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
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