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

Trial Profile

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

Status: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 20 Apr 2020

At a glance

  • Drugs Mavrilimumab (Primary)
  • Indications COVID 2019 infections; Pneumonia
  • Focus Therapeutic Use
  • Most Recent Events

    • 16 Apr 2020 Planned End Date changed from 1 Jul 2020 to 1 Aug 2020.
    • 16 Apr 2020 Planned primary completion date changed from 1 Jul 2020 to 1 Aug 2020.
    • 16 Apr 2020 Planned initiation date changed from 1 Apr 2020 to 1 May 2020.

Trial Overview

Purpose

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.

Primary Endpoints

Time to resolution of fever

description: Body temperature will be measured in celsius
time_frame: Up to 28 days

Other Endpoints

Change in clinical status

description: 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.
time_frame: Baseline to up to 28 days

Mortality

description: Number of deaths during 28 day follow-up period
time_frame: 28 days

Change in CRP

description: Change in CRP levels
time_frame: Baseline to up to 28 days or discharge

Change in IL-6

description: Change in IL-6 levels
time_frame: Baseline to up to 28 days or discharge [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Pneumonia treatment severe

Subjects

  • Subject Type patients
  • Number

    Planned: 10

  • Sex male & female
  • Age Group ≥ 18 years; adult

Patient 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).

Patient 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

Trial Details

Identifiers

Identifier Owner
NCT04337216 ClinicalTrials.gov: US National Institutes of Health
HM20019145 -

Trial Dates

  • Initiation Dates

    Planned : 01 May 2020

  • Primary Completion Dates

    Planned : 01 Aug 2020

  • End Dates

    Planned : 01 Aug 2020

Other Details

  • Design open; prospective
  • Phase of Trial Phase II
  • Location USA
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
MavrilimumabPrimary Drug Intravenous
-

Mavrilimumab

Drug: Mavrilimumab (single IV dose of mavrilimumab)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Antonio Abbate, MD, PhD Virginia Commonwealth University USA

Centres

Centre Name Location Trial Centre Country
Virginia Commonwealth University
-
-
Virginia Commonwealth University Richmond, Virginia USA

Trial History

Event Date Event Type Comment
20 Apr 2020 Other trial event Last checked against the ClinicalTrials.gov record. Updated 20 Apr 2020
16 Apr 2020 Completion date Planned End Date changed from 1 Jul 2020 to 1 Aug 2020. Updated 20 Apr 2020
16 Apr 2020 Other trial event Planned primary completion date changed from 1 Jul 2020 to 1 Aug 2020. Updated 20 Apr 2020
16 Apr 2020 Other trial event Planned initiation date changed from 1 Apr 2020 to 1 May 2020. Updated 20 Apr 2020
09 Apr 2020 New trial record New trial record Updated 09 Apr 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
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