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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04337216
• Other study ID #: HM20019145
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 2020
• Est. completion date: August 2020

Study information

• Verified date: April 2020
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Inflammation
• Pneumonia
• Respiratory Insufficiency

Intervention

Drug:
• Mavrilimumab
single IV dose of mavrilimumab

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to resolution of fever	Body temperature will be measured in celsius	Up to 28 days
Secondary	Change in clinical status	Clinical status will be assessed using 6-category scale: 1. Not hospitalized, 2. Hospitalized, no supplemental oxygen, 3. Hospitalized, on supplemental oxygen, 4. Hospitalized, requiring nasal high-flow oxygen or non-invasive ventilation, 5. Hospitalized, requiring ECMO, invasive mechanical ventilation or both, 6. Death.	Baseline to up to 28 days
Secondary	Mortality	Number of deaths during 28 day follow-up period	28 days
Secondary	Change in CRP	Change in CRP levels	Baseline to up to 28 days or discharge
Secondary	Change in IL-6	Change in IL-6 levels	Baseline to up to 28 days or discharge