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

Completed · Phase 2 · Has a placebo group

Conditions studied: COVID-19, Sars-CoV2, Pneumonia

In brief

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.

Key facts

Study ID: NCT04463004
Run by: Virginia Commonwealth University
People needed: 2
Starts: 2020-09-02
Expected to finish: 2020-11-30
Last updated by the study team: 2021-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Written informed consent must be obtained before any assessment is performed
Documented COVID19 pneumonia defined as positive SARS-CoV2 test AND abnormalities/ infiltrates on chest x-ray or computed tomography AND active fever or documented fever within 24-48 hours or ongoing anti-pyretic use to suppress fever
Hypoxia (Room air SpO2 <92% or requirement for supplemental oxygen)
Increased serum inflammatory marker (CRP > 5 mg/dL)
Severity of disease warrants inpatient hospitalization

You may not qualify if…

Onset of COVID-19 symptoms >14 days
Age < 18 years-old
Hospitalized >7 days
Mechanically ventilated
Serious concomitant illness which in the opinion of the investigator precludes the patient from enrolling in the trial, including (but not limited to):
History of immunodeficiency (congenital or acquired)
Neutropenia (absolute neutrophil count <1,500/mm3)
History of solid-organ or bone marrow transplant
History of current systemic autoimmune or autoinflammatory disease(s) requiring systemic immune-modulating drugs
History of myeloproliferative disorder or active malignancy receiving cytotoxic chemotherapy
Pre-existing severe pulmonary disease (i.e. steroid dependent asthma, COPD on home oxygen, or other restrictive/obstructive lung disease requiring home oxygen)
Pre-existing severe left ventricular systolic dysfunction (i.e. LVEF <35%)
Known or suspected active tuberculosis (TB), latent TB, or history of incompletely treated TB or at high risk for latent TB (from exposure or prior incarceration)
History of active or latent viral hepatitis (i.e. Hepatitis B or C)
Concomitant uncontrolled systemic bacterial or fungal infection
Concomitant viral infection other than COVID-19 (e.g. Influenza, other respiratory viruses)
History of chronic liver disease with portal hypertension
History of end-stage renal disease on chronic renal replacement therapy
Recent treatment with cell-depleting biological therapies (e.g., anti-CD20) within 12 months, cell-depleting biological therapies (such as anti-tumor necrosis factor [TNF], anakinra, anti-Interleukin [IL]-6 receptor [e.g. tocilizumab], or abatacept) within 8 weeks (or 5 half-lives, whichever is longer), treatment with alkylating agents within 12 weeks, treatment with cyclosporine A, azathioprine, cyclophosphamide, or mycophenolate mofetil (MMF) within 4 weeks
Recent treatment with intramuscular live (attenuated) vaccine within 4 weeks
Chronic or recent corticosteroid use > 10 mg/day
Pregnant. Breast-feeding women are eligible with the decision to continue or discontinue breast-feeding during therapy taking into account the risk of infant exposure, the benefits of breast-feeding to the infant, and benefits of treatment to the mother
Enrolled in another investigational study using immunosuppressive therapy
Known hypersensitivity to mavrilimumab or any of its excipients
In the opinion of the investigator, unable to comply with the requirements to participate in the study

Where it is running

Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.