Mavrilimumab to Reduce Progression of Acute Respiratory Failure in

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04399980
Study type	Interventional
Source	The Cleveland Clinic
Contact
Status	Completed
Phase	Phase 2
Start date	May 20, 2020
Completion date	April 23, 2021

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04244474` - Effect of Vitamin D Supplementation on Improvement of Pneumonic Children	Phase 1/Phase 2
Completed	`NCT05815264` - Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Chinese Population Aged 2 Years and Above	Phase 1
Recruiting	`NCT04589936` - Prone Position to Improve Oxygenation in COVID-19 Patients Outside Critical Care	N/A
Completed	`NCT02905383` - The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital	N/A
Completed	`NCT06210737` - A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years	Phase 4
Terminated	`NCT03944551` - Bubble Continuous Positive Airway Pressure for Children With Severe Pneumonia in Mali, Africa	N/A
Terminated	`NCT04660084` - Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP	N/A
Not yet recruiting	`NCT05649891` - Checklists Resuscitation Emergency Department	N/A
Withdrawn	`NCT05702788` - Efficacy and Safety of Jaktinib in Participants With Severe Novel Coronavirus Pneumonia(COVID-19)	Phase 2
Not yet recruiting	`NCT04171674` - Pharmacokinetics of High-dose Ceftobiprole in Community-acquired Pneumonia Under Mechanical Ventilation.	N/A
Active, not recruiting	`NCT03140163` - Screening for Pneumonia: A Comparison of Ultra Low Dose Chest CT [ULD-CT] and Conventional Chest Radiography [CXR]	N/A
Completed	`NCT02638649` - Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
Completed	`NCT02864420` - Hospitalization at Home: The Acute Care Home Hospital Program for Adults	N/A
Recruiting	`NCT02515565` - Physiotherapy in Patients Hospitalized Due to Pneumonia.	N/A
Completed	`NCT02105298` - Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)	N/A
Completed	`NCT01399723` - Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia	Phase 3
Completed	`NCT01416519` - Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation	N/A
Completed	`NCT01446926` - Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants	Phase 1
Completed	`NCT01476995` - Prognostic Indicators as Provided by the EPIC ClearView	N/A
Completed	`NCT01416506` - Community-Acquired Pneumonia (CAP) Surveillance	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms