Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation
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|ClinicalTrials.gov Identifier: NCT04399980|
Recruitment Status : Recruiting
First Posted : May 22, 2020
Last Update Posted : May 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID 19 SARS-CoV 2 Pneumonia||Drug: Mavrilimumab Drug: Placebos||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 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, 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|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Mavrilimumab to Reduce Progression of Acute Respiratory Failure in Patients With Severe 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|
Active Comparator: Intervention
Other Name: KPL-301
Placebo Comparator: Control
Other Name: Control
- Proportion of subjects alive and off of oxygen at day 14 [ Time Frame: Day 14 ]Number of subjects alive and off of oxygen
- Proportion of subjects alive and without respiratory failure at 28 days [ Time Frame: Day 28 ]Number of subjects alive and without respiratory failure
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): NCT04399980
|Contact: Paul C Cremer, M. D.||firstname.lastname@example.org|
|Contact: Yuki Kuramochi, BSN, RNemail@example.com|
|United States, Ohio|
|Cleveland Clinic Health System||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Paul C Cremer, M. D. 216-445-6765 firstname.lastname@example.org|
|Sub-Investigator: Venu Menon, M. D.|
|Sub-Investigator: Ossama K Abou Hassan, M. D.|
|Sub-Investigator: Calvin Sheng, M. D.|
|Sub-Investigator: Shiddharth P Dugar, M. D.|
|Sub-Investigator: Tom Wang, M. D.|
|Sub-Investigator: Debases Sahoo, M.D.|
|Sub-Investigator: Alice Goyanes, M. D.|
|Sub-Investigator: Narendrakumar Alappan, M. D.|
|Sub-Investigator: Ravi Sunderkrishnan, M. D.|
|Sub-Investigator: Robier Aguillon-Prada, M. D.|
|Sub-Investigator: Prabalini Rajendram, M. D.|
|Principal Investigator:||Paul C Cremer, M. D.||The Cleveland Clinic|