Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemi… (NCT04492514) | Clinical Trial Compass
CompletedPhase 2
Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation
United States1 participantsStarted 2020-05-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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)
✓. Severity of disease warrants inpatient hospitalization
Exclusion criteria
✕. 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):
✕. 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
What they're measuring
1
Proportion of Subjects Alive and Off Oxygen at 14 Days