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-CoV 2, 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
- NCT04399980
- Run by
- The Cleveland Clinic
- People needed
- 40
- Starts
- 2020-05-20
- Expected to finish
- 2021-04-23
- Last updated by the study team
- 2021-05-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- Cleveland Clinic Florida — Weston, Florida, United States
- Cleveland Clinic Health System — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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