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.
This prospective, Phase 2, multi-center, blinded randomized placebo-controlled study is designed 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. The study population includes patients who have severe pneumonia, defined as hospitalization due to Covid-19 with abnormal chest imaging and SpO2 \<92% on room air or requirement for supplemental oxygen. Enrollment: The study will be performed in approximately 4 months total, starting from the first patient enrolled with enrollment expected to complete within 2 months. Follow-up period: The follow-up period is 60 days for each patient enrolled. A total of 60 patients will be randomized using a 1:1 allocation ratio: 30 subjects will receive mavrilimumab, and 30 subjects will receive placebo infusion. The investigator, clinical team, and subject will be blinded to treatment assignment. Participants will be identified by regular review of hospitalized COVID19 patients to evaluate for inclusion and exclusion criteria. Participants will then be approached in the standard manner by study investigator and coordinator/research nurse. Research interventions will take place in the hospital in accordance with privacy standards. The study team is informed on all study procedures and requirements with daily meetings and the opportunity to continuously update through secure channels. In this multicenter consortium, each participating site will have their own IND for patients enrolled at their site. Data collection will occur at each of the 4 academic centers, and data analysis and randomization scheme will be performed by one site, Cleveland Clinic C5 Research.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Treatment infusion
Placebo infusion
Cleveland Clinic Florida
Weston, Florida, United States
Cleveland Clinic Health System
Cleveland, Ohio, United States
Subjects Alive and Off of Oxygen at Day 14
Number and percentage of subjects alive and off of oxygen at day 14
Time frame: Day 14
Number of Subjects Alive and Without Respiratory Failure at Day 28
Number and percentage of subjects that are alive and without respiratory failure at Day 28
Time frame: Day 28
Mortality at Day 28
Number and percentage of patients that expired by Day 28
Time frame: Day 28
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