Mavrilimumab to Reduce Progression of Acute Respiratory Failure in Patients With Severe COVID-19 Pneumonia and Systemic Hyper-inflammation
Latest Information Update: 04 Nov 2021
At a glance
- Drugs Mavrilimumab (Primary)
- Indications COVID 2019 infections; Pneumonia
- Focus Therapeutic Use
- 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.
Most Recent Events
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 |
Biomarker
NCT Number | Biomarker Name | Biomarker Function |
---|---|---|
NCT04337216 | C-reactive protein (CRP) | Outcome Measure |
Interleukin-6 (IL-6) | Outcome Measure |
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 |
17 Apr 2020 | Biomarker Update | Biomarkers information updated Updated 04 Nov 2021 |
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
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov
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