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

• Status: Not yet recruiting
• Trial end date: 2020-07-01
• Target enrollment: 10
• Participant gender: All

Summary

The primary endpoint of this study is to assess the effects of a single IV dose of mavrilimumab on the acute inflammatory response in patients with severe COVID-19 pneumonia

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Treatments: Antibodies, Monoclonal; Mavrilimumab

Criteria

Inclusion Criteria:

• Documented COVID19 pneumonia (positive SARS-CoV2 test, bilateral abnormalities/ infiltrates on chest x-ray or computed tomography, active fever or documented fever within 24-48 or ongoing anti-pyretic use to suppress fever).

• Hypoxia (room air SpO2 <92% or requirement for supplemental oxygen).

• Increased serum inflammatory markers (CRP > 5 mg/dl AND LDH >upper limit of normal for local laboratory).

Exclusion Criteria:

• Onset of COVID-19 >14 days

• Hospitalized >7 days

• Mechanically ventilated

• Age <18 years-old

• Neutropenia (absolute neutrophil count <1,500/mm3)

• 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)

• 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. asthma, COPD, or others)

• Pre-existing severe left ventricular systolic dysfunction (i.e. LVEF <35%)

• Known active tuberculosis (TB) or history of incompletely treated TB or at high risk for latent TB (for exposure or prior incarceration)

• Concomitant systemic bacterial or fungal infection

• Concomitant viral infection other than COVD-19 (e.g. influenza)

• 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 noncell-depleting biological therapies (such as anti-tumor necrosis factor-alpha [TNF-alpha], 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 the 4 weeks

• Chronic or recent corticosteroid use

• Pregnancy or lactation or newborn

• Enrolled in another investigational study using immunosuppressive therapy

• Enrolled in a blinded clinical trial of any type

• 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