NCT04399980

Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation

Mavrilimumab to Reduce Progression of Acute Respiratory Failure in Patients With Severe COVID-19 Pneumonia and Systemic Hyper-inflammation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• COVID 19
• SARS-CoV 2
• Pneumonia

Interventions

Type	Name	Description
DRUG	Mavrilimumab	Treatment infusion
DRUG	Placebos	Placebo infusion

Timeline

• Start date: 2020-05-20
• Primary completion: 2021-04-23
• Completion: 2021-04-23
• First posted: 2020-05-22
• Last updated: 2021-05-13
• Results posted: 2021-05-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study