Evidence map›Paper›PMID 36218354›Full record

Trial reportCritical care medicine2022

Avdoralimab (Anti-C5aR1 mAb) Versus Placebo in Patients With Severe COVID-19: Results From a Randomized Controlled Trial (FOR COVID Elimination [FORCE]).

Julien Carvelli, Ferhat Meziani, Jean Dellamonica, Pierre-Yves Cordier, Jerome Allardet-Servent, Megan Fraisse, Lionel Velly, Saber Davide Barbar, Samuel Lehingue, Christophe Guervilly and 17 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Critical care medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04371367 (A Double-blind, Randomized Study Versus Placebo of Avdoralimab), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
2.6field-weighted citation impact, top 8% 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.

NCT04371367 phase2completednot on this map

A Double-blind, Randomized Study Versus Placebo of Avdoralimab (IPH5401), an Anti-C5aR Antibody, in Patients With COVID-19 Severe Pneumonia

TypeinterventionalSponsorAssistance Publique Hopitaux De MarseilleRan2020 to 2021Enrolled208ConditionsCOVIDArmsavdoralimab, Placebo
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 26 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Article
  6. Review
  7. Treatment of Bullous Pemphigoid with Avdoralimab: Multicenter, Randomized, Open-Labeled Phase 2 Study.JID innovations : skin science from molecules to population health · 2024
    Article
  8. Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Observational
  14. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 2 institutions in 1 country.

Julien CarvelliAP-HM, Department of Intensive Care, Réanimation des Urgences, Medecine Intensive & Reanimation, Timone University Hospital, Marseille, France.
Ferhat MezianiDepartment of Intensive Care, Médecine Intensive & Réanimation, Nouvel Hôpital Civil, Strasbourg University Hospital, INSERM (French National Institute of Health and Medical Research), UMR 1260, Regenerative Nanomedicine (RNM), FMTS (Fédération de Médecine Translationnelle de Strasbourg), Strasbourg University, Strasbourg, France.
Jean DellamonicaDepartment of Intensive Care, Medecine Intensive & Reanimation, Hôpital l'Archet 1, Nice University Hospital, Cote d'Azur University, UR2CA, Nice, France.
Pierre-Yves CordierDepartment of Intensive Care, Réanimation Polyvalente, HIA Laveran, Marseille, France.
Jerome Allardet-ServentDepartment of Intensive Care, Hôpital Européen, Marseille, France.
Megan FraisseDepartment of Intensive Care, Réanimation Polyvalente, Centre Hospitalier Victor Dupouy, Argenteuil, France.
Lionel VellyAix-Marseille University, Marseille, France.
Saber Davide BarbarDepartment of Intensive Care, Nîmes University Hospital, University of Montpellier, Nîmes, France.
Samuel LehingueDepartment of Intensive Care, Hôpital Saint-Joseph, Marseille, France.
Christophe GuervillyAix-Marseille University, Marseille, France.
Maxime DesgrouasDepartment of Intensive Care, Medecine Intensive & Reanimation, Centre Hospitalier Régional d'Orléans, Orléans, France.
Fabrice CamouDepartment of Intensive Care, Bordeaux University Hospital, Hôpital Saint-André, University of Bordeaux, Bordeaux, France.
Christelle PiperoglouMarseille Immunopôle, Timone University Hospital, CNRS, INSERM, CIML, Marseille, France.
Frederic VelyMarseille Immunopôle, Timone University Hospital, CNRS, INSERM, CIML, Marseille, France.
Olivier DemariaInnate Pharma, Marseille, France.
Joyson KarakunnelInnate Pharma, Marseille, France.
Joanna FaresInnate Pharma, Marseille, France.
Luciana BatistaInnate Pharma, Marseille, France.
Federico RotoloInnate Pharma, Marseille, France.
Julien ViottiInnate Pharma, Marseille, France.
Agnes Boyer-ChammardInnate Pharma, Marseille, France.
Karine LacombeAP-HP, Tropical Medicine & Infectious Diseases, Saint-Antoine Univeristy Hospital, Sorbonne University, Inserm UMR-S1136 IPLESP, Paris, France.
Erwan Le DaultTropical Medicine & Infectious Diseases, HIA Laveran, Marseille, France.
Michel CarlesTropical Medicine & Infectious Diseases, Hôpital l'Archet 1, Nice Univeristy Hospital, Université Côte d'Azur, Inserm-C3M, Nice, France.
Nicolas SchleinitzMarseille Immunopôle, Timone University Hospital, CNRS, INSERM, CIML, Marseille, France.
Eric VivierMarseille Immunopôle, Timone University Hospital, CNRS, INSERM, CIML, Marseille, France.
FOR COVID Elimination (FORCE) Study Group
Innate Pharma (France) · FRAix-Marseille Université · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesSevere COVID-19 is associated with exaggerated complement activation. We assessed the efficacy and safety of avdoralimab (an anti-C5aR1 mAb) in severe COVID-19.

designFOR COVID Elimination (FORCE) was a double-blind, placebo-controlled study.

settingTwelve clinical sites in France (ICU and general hospitals). PATIENTS: Patients receiving greater than or equal to 5 L oxygen/min to maintain Sp o2 greater than 93% (World Health Organization scale ≥ 5). Patients received conventional oxygen therapy or high-flow oxygen (HFO)/noninvasive ventilation (NIV) in cohort 1; HFO, NIV, or invasive mechanical ventilation (IMV) in cohort 2; and IMV in cohort 3.

interventionsPatients were randomly assigned, in a 1:1 ratio, to receive avdoralimab or placebo. The primary outcome was clinical status on the World Health Organization ordinal scale at days 14 and 28 for cohorts 1 and 3, and the number of ventilator-free days at day 28 (VFD28) for cohort 2. MEASUREMENTS AND MAIN

resultsWe randomized 207 patients: 99 in cohort 1, 49 in cohort 2, and 59 in cohort 3. During hospitalization, 95% of patients received glucocorticoids. Avdoralimab did not improve World Health Organization clinical scale score on days 14 and 28 (between-group difference on day 28 of -0.26 (95% CI, -1.2 to 0.7; p = 0.7) in cohort 1 and -0.28 (95% CI, -1.8 to 1.2; p = 0.6) in cohort 3). Avdoralimab did not improve VFD28 in cohort 2 (between-group difference of -6.3 (95% CI, -13.2 to 0.7; p = 0.96) or secondary outcomes in any cohort. No subgroup of interest was identified.

conclusionsIn this randomized trial in hospitalized patients with severe COVID-19 pneumonia, avdoralimab did not significantly improve clinical status at days 14 and 28 (funded by Innate Pharma, ClinicalTrials.gov number, NCT04371367).

Indexed as

COVID-19Antibodies, Monoclonal, HumanizedHumansOxygenSARS-CoV-2Treatment OutcomeAntibodies, Monoclonal, HumanizedavdoralimabOxygen

Identifiers

PMID36218354
PMCPMC9674430
OpenAlexW4304191831

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.