Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflation
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|ClinicalTrials.gov Identifier: NCT04492514|
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : July 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID 19 SARS-CoV 2 Pneumonia||Drug: Mavrilimumab Drug: Placebo||Phase 2|
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 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 COVID 19 patients to evaluate for inclusion and exclusion criteria. Participants will then be approached in this standard manner by study investigator and/or coordinator/research nurse.
Research interventions will take place in the hospital in accordance with privacy standards.
The study team in informed on all study procedures and requirements with daily meetings and the opportunity to continuously update through secure channels.
In this multicenter consortium of 4 academic centers, 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. Data analysis and randomization scheme will be performed by the Cleveland Clinic C5 Research, data analysis, and randomization scheme will be performed by one site, Cleveland Clinic C5 Research.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Factorial Assignment|
|Intervention Model Description:||Factorial Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Quadruple (Particiapnt, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation|
|Actual Study Start Date :||May 20, 2020|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2021|
Mavrilimumab treatment infusion
Other Name: KPL-301
Placebo Comparator: Placebo
Other Name: Control
- Primary Outcome Measure: [ Time Frame: Day 14 ]Proportion of subjects alive and off oxygen at day14
- Secondary Outcome Measures: [ Time Frame: 28 days ]Proportion of subjects alive and without respiratory failure at 28 days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04492514
|Contact: Kristin Hudock, MDfirstname.lastname@example.org|
|Contact: Autumn Cresieemail@example.com|
|Principal Investigator:||Kristin Hudock, MD||University of Cincinnati|