Evidence map›Paper›PMID 33754144›Full record

ArticleThe Lancet. Rheumatology2021

Mavrilimumab in patients with severe COVID-19 pneumonia and systemic hyperinflammation (MASH-COVID): an investigator initiated, multicentre, double-blind, randomised, placebo-controlled trial.

Paul C Cremer, Antonio Abbate, Kristin Hudock, Carla McWilliams, Jinesh Mehta, Steven Y Chang, Calvin C Sheng, Benjamin Van Tassell, Aldo Bonaventura, Alessandra Vecchié and 9 more

3 registry-linked trialsOpen access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The Lancet. Rheumatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 49 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 5 pooled it
4.2field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04399980 phase2completednot on this map

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

TypeinterventionalSponsorThe Cleveland ClinicRan2020 to 2021Enrolled40ConditionsCOVID 19, SARS-CoV 2, PneumoniaArmsMavrilimumab, Placebos
NCT04463004 phase2completednot on this map

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

TypeinterventionalSponsorVirginia Commonwealth UniversityRan2020 to 2020Enrolled2ConditionsCOVID-19, Sars-CoV2, PneumoniaArmsMavrilimumab, Placebos
NCT04492514 phase2completednot on this map

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

TypeinterventionalSponsorKristin HudockRan2020 to 2020Enrolled1ConditionsCOVID 19, SARS-CoV 2, PneumoniaArmsMavrilimumab, Placebo
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 5 syntheses or guidelines pooled it, 68 citations in OpenAlex.

  1. Pooled it
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  10. Adverse drug reactions associated with COVID-19 management.Naunyn-Schmiedeberg's archives of pharmacology · 2024
    Review
  11. Making Drug Approval Decisions in the Face of Uncertainty: Cumulative Evidence versus Value of Information.Medical decision making : an international journal of the Society for Medical Decision Making · 2024
    Article
  12. COVID-19 Pneumonia and Cytokine Storm Syndrome.Advances in experimental medicine and biology · 2024
    Review
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  14. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 8 institutions in 1 country.

Paul C CremerDepartment of Cardiovascular Medicine, The Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, OH, USA.
Antonio AbbateWright Center for Clinical and Translational Research, Virginia Commonwealth University, Richmond, VA, USA.
Kristin HudockDivision of Pulmonary, Critical Care and Sleep Medicine, Division of Pulmonary Biology, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA.
Carla McWilliamsDepartment of Infectious Disease, Cleveland Clinic Florida, Weston, FL, USA.
Jinesh MehtaDepartment of Pulmonary and Critical Care, Cleveland Clinic Florida, Weston, FL, USA.
Steven Y ChangDivision of Pulmonary and Critical Care Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
Calvin C ShengDepartment of Cardiovascular Medicine, The Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, OH, USA.
Benjamin Van TassellWright Center for Clinical and Translational Research, Virginia Commonwealth University, Richmond, VA, USA.
Aldo BonaventuraWright Center for Clinical and Translational Research, Virginia Commonwealth University, Richmond, VA, USA.
Alessandra VecchiéWright Center for Clinical and Translational Research, Virginia Commonwealth University, Richmond, VA, USA.
Brenna CareyDivision of Pulmonary, Critical Care and Sleep Medicine, Division of Pulmonary Biology, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA.
Qiuqing WangDepartment of Cardiovascular Medicine, The Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, OH, USA.
Katherine E WolskiDepartment of Cardiovascular Medicine, The Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, OH, USA.
Prabalini RajendramDepartment of Pulmonary Medicine, The Respiratory Institute, Cleveland Clinic, Cleveland, OH, USA.
Abhijit DuggalDepartment of Pulmonary Medicine, The Respiratory Institute, Cleveland Clinic, Cleveland, OH, USA.
Tisha S WangDivision of Pulmonary and Critical Care Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
John F PaoliniKiniksa Pharmaceuticals, Lexington, MA, USA.
Bruce C TrapnellDivision of Pulmonary, Critical Care and Sleep Medicine, Division of Pulmonary Biology, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, USA.
MASH-COVID study group
Cleveland Clinic · USVirginia Commonwealth University · USCleveland Clinic Florida · USUniversity of California, Los Angeles · USUniversity of Cincinnati · USCenter for Clinical Research (United States) · USCincinnati Children's Hospital Medical Center · USSynta Pharmaceuticals (United States) · US

Funding

Pulmonary Macrophage Transplantation for Pulmonary Alveolar ProteinosisR01HL118342 · NHLBI · CINCINNATI CHILDRENS HOSP MED CTR · PI TRAPNELL, BRUCE C, TRAPNELL, BRUCE COLSTON · 2014 to 2021
$4.5M
NHLBI NIH HHS R01 HL118342
6 · The paper itself

Abstract

backgroundIn patients with COVID-19, granulocyte-macrophage colony stimulating factor (GM-CSF) might be a mediator of the hyperactive inflammatory response associated with respiratory failure and death. We aimed to evaluate whether mavrilimumab, a monoclonal antibody to the GM-CSF receptor, would improve outcomes in patients with COVID-19 pneumonia and systemic hyperinflammation.

methodsThis investigator-initiated, multicentre, double-blind, randomised trial was done at seven hospitals in the USA. Inclusion required hospitalisation, COVID-19 pneumonia, hypoxaemia, and a C-reactive protein concentration of more than 5 mg/dL. Patients were excluded if they required mechanical ventilation. Patients were randomly assigned (1:1) centrally, with stratification by hospital site, to receive mavrilimumab 6 mg/kg as a single intravenous infusion, or placebo. Participants and all clinical and research personnel were masked to treatment assignment. The primary endpoint was the proportion of patients alive and off supplemental oxygen therapy at day 14. The primary outcome and safety were analysed in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT04399980, NCT04463004, and NCT04492514.

findingsBetween May 28 and Sept 15, 2020, 40 patients were enrolled and randomly assigned to mavrilimumab (n=21) or placebo (n=19). A trial of 60 patients was planned, but given slow enrolment, the study was stopped early to inform the natural history and potential treatment effect. At day 14, 12 (57%) patients in the mavrilimumab group were alive and off supplemental oxygen therapy compared with nine (47%) patients in the placebo group (odds ratio 1·48 [95% CI 0·43-5·16]; p=0·76). There were no treatment-related deaths, and adverse events were similar between groups.

interpretationThere was no significant difference in the proportion of patients alive and off oxygen therapy at day 14, although benefit or harm of mavrilimumab therapy in this patient population remains possible given the wide confidence intervals, and larger trials should be completed.

fundingKiniksa Pharmaceuticals.

Identifiers

PMID33754144
PMCPMC7969143
OpenAlexW3136776366

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.