Effect of early treatment with polyvalent immunoglobulin on acute respiratory distress syndrome associated with SARS-CoV-2 infections (ICAR trial): study protocol for a randomized controlled trial

Detalhes bibliográficos
Autor(a) principal: Mazeraud, Aurélien
Data de Publicação: 2021
Outros Autores: Gonçalves, Bruno, Aegerter, Philippe, Mancusi, Letizia, Rieu, Christine, Bozza, Fernando, Sylla, Khaoussou, Siami, Shidasp, Sharshar, Tarek
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/50536
Resumo: GHU Paris Psychiatrie et neurosciences. Service de Neuroanesthésie Neuroréanimation. Paris, France / Univeristé de Paris. Paris, France.
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spelling Mazeraud, AurélienGonçalves, BrunoAegerter, PhilippeMancusi, LetiziaRieu, ChristineBozza, FernandoSylla, KhaoussouSiami, ShidaspSharshar, Tarek2021-12-28T13:23:31Z2021-12-28T13:23:31Z2021MAZERAUD, Aurélien et al. Effect of early treatment with polyvalent immunoglobulin on acute respiratory distress syndrome associated with SARS-CoV-2 infections (ICAR trial): study protocol for a randomized controlled trial. Trials, v. 22, n. 1, p. 1-13, 20211745-6215https://www.arca.fiocruz.br/handle/icict/5053610.1186/s13063-021-05118-7engBMCEffect of early treatment with polyvalent immunoglobulin on acute respiratory distress syndrome associated with SARS-CoV-2 infections (ICAR trial): study protocol for a randomized controlled trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleGHU Paris Psychiatrie et neurosciences. Service de Neuroanesthésie Neuroréanimation. Paris, France / Univeristé de Paris. Paris, France.GHU Paris Psychiatrie et neurosciences. Service de Neuroanesthésie Neuroréanimation. Paris, France / Instituto Estadual do Cérebro Paulo Niemeyer. Rio de Janeiro, RJ, Brasil.Université Paris-Saclay. Cellule Méthodologie. GIRCI-IDF. Paris, France / Centre de recherche en Epidémiologie et Santé des Populations. Équipe d'Épidémiologie respiratoire intégrative. Villejuif, France.GHU Paris Psychiatrie et neurosciences. Service de Neuroanesthésie Neuroréanimation. Paris, France.GHU Paris Psychiatrie et neurosciences. Service de Neuroanesthésie Neuroréanimation. Paris, France.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil / Instituto Estadual do Cérebro Paulo Niemeyer. Rio de Janeiro, RJ, Brasil.GHU Paris Psychiatrie et neurosciences. Service de Neuroanesthésie Neuroréanimation. Paris, France.CH Sud-Essonnes. Service de Réanimation. Etampes, France.GHU Paris Psychiatrie et neurosciences. Service de Neuroanesthésie Neuroréanimation. Paris, France / Univeristé de Paris. Paris, France. /Background: As of mid-June 2020, 7,500,000 people were infected with SARS-CoV-2 worldwide and 420,000 people died, mainly from coronavirus disease 2019 (COVID-19)-related acute respiratory distress syndrome (ARDS). COVID-19-related ARDS is subject to a mortality rate of 50% and prolonged period of mechanical ventilation, with no specific pharmacological treatment currently available (Infection au nouveau Coronavirus (SARS-CoV-2), COVID-19, France et Monde. https://www.santepubliquefrance.fr/dossiers/coronavirus-covid-19 ). Because of its immunomodulatory action, we propose to evaluate the efficacy and safety of intravenous immunoglobulin (IVIG) administration in patients developing COVID-19-related ARDS. Methods: The trial is a phase III double-blind, randomized, multicenter, parallel group, concurrent, controlled study in hospitalized participants with COVID-19 requiring mechanical ventilation using a sequential design. Participants in the treatment group will receive infusions of polyvalent immunoglobulin for 4 consecutive days, and the placebo group will receive an equivalent volume of sodium chloride 0.9% for the same duration. The primary outcome is the number of ventilator-free days up to the 28th day. Secondary objectives are to evaluate the effect of IVIG on (1) organ failure according to the Sequential Organ Failure Assessment (SOFA) score at 14 and 28 days, (2) lung injury score at 14 and 28 days, (3) the occurrence of grade 3 or 4 adverse events of IVIG, (4) length of intensive care unit (ICU) stay, (5) length of hospital stay, (6) functional outcomes at day 90 defined by the activities of daily living and instrumental activities of the daily living scales, and (7) 90-day survival. One hundred thirty-eight subjects will be randomized in a 1:1 ratio to IVIG or placebo groups (69 in each group), considering 90% power, alpha level 0.05 (two sides), and 0.67 effect size level. Discussion: The ICAR trial investigates the effect of IVIG in COVID-19-related ARDS. We expect an increase in the survival rate and a reduction in the duration of mechanical ventilation, which is associated with significant morbidity.Acute respiratory distress syndromeCOVID-19Polyvalent immunoglobulinSARS-CoV-2info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83099https://www.arca.fiocruz.br/bitstream/icict/50536/1/license.txt586c046dcfeef936e32f0323bb9a47c0MD51ORIGINALEffect of early_Fernando_Bozza_etal_INI_2021_COVID-19.pdfEffect of early_Fernando_Bozza_etal_INI_2021_COVID-19.pdfapplication/pdf623744https://www.arca.fiocruz.br/bitstream/icict/50536/2/Effect%20of%20early_Fernando_Bozza_etal_INI_2021_COVID-19.pdfc0565518e92059d156e771debcc043c8MD52icict/505362021-12-28 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dc.title.pt_BR.fl_str_mv Effect of early treatment with polyvalent immunoglobulin on acute respiratory distress syndrome associated with SARS-CoV-2 infections (ICAR trial): study protocol for a randomized controlled trial
title Effect of early treatment with polyvalent immunoglobulin on acute respiratory distress syndrome associated with SARS-CoV-2 infections (ICAR trial): study protocol for a randomized controlled trial
spellingShingle Effect of early treatment with polyvalent immunoglobulin on acute respiratory distress syndrome associated with SARS-CoV-2 infections (ICAR trial): study protocol for a randomized controlled trial
Mazeraud, Aurélien
Acute respiratory distress syndrome
COVID-19
Polyvalent immunoglobulin
SARS-CoV-2
title_short Effect of early treatment with polyvalent immunoglobulin on acute respiratory distress syndrome associated with SARS-CoV-2 infections (ICAR trial): study protocol for a randomized controlled trial
title_full Effect of early treatment with polyvalent immunoglobulin on acute respiratory distress syndrome associated with SARS-CoV-2 infections (ICAR trial): study protocol for a randomized controlled trial
title_fullStr Effect of early treatment with polyvalent immunoglobulin on acute respiratory distress syndrome associated with SARS-CoV-2 infections (ICAR trial): study protocol for a randomized controlled trial
title_full_unstemmed Effect of early treatment with polyvalent immunoglobulin on acute respiratory distress syndrome associated with SARS-CoV-2 infections (ICAR trial): study protocol for a randomized controlled trial
title_sort Effect of early treatment with polyvalent immunoglobulin on acute respiratory distress syndrome associated with SARS-CoV-2 infections (ICAR trial): study protocol for a randomized controlled trial
author Mazeraud, Aurélien
author_facet Mazeraud, Aurélien
Gonçalves, Bruno
Aegerter, Philippe
Mancusi, Letizia
Rieu, Christine
Bozza, Fernando
Sylla, Khaoussou
Siami, Shidasp
Sharshar, Tarek
author_role author
author2 Gonçalves, Bruno
Aegerter, Philippe
Mancusi, Letizia
Rieu, Christine
Bozza, Fernando
Sylla, Khaoussou
Siami, Shidasp
Sharshar, Tarek
author2_role author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Mazeraud, Aurélien
Gonçalves, Bruno
Aegerter, Philippe
Mancusi, Letizia
Rieu, Christine
Bozza, Fernando
Sylla, Khaoussou
Siami, Shidasp
Sharshar, Tarek
dc.subject.en.pt_BR.fl_str_mv Acute respiratory distress syndrome
COVID-19
Polyvalent immunoglobulin
SARS-CoV-2
topic Acute respiratory distress syndrome
COVID-19
Polyvalent immunoglobulin
SARS-CoV-2
description GHU Paris Psychiatrie et neurosciences. Service de Neuroanesthésie Neuroréanimation. Paris, France / Univeristé de Paris. Paris, France.
publishDate 2021
dc.date.accessioned.fl_str_mv 2021-12-28T13:23:31Z
dc.date.available.fl_str_mv 2021-12-28T13:23:31Z
dc.date.issued.fl_str_mv 2021
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv MAZERAUD, Aurélien et al. Effect of early treatment with polyvalent immunoglobulin on acute respiratory distress syndrome associated with SARS-CoV-2 infections (ICAR trial): study protocol for a randomized controlled trial. Trials, v. 22, n. 1, p. 1-13, 2021
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/50536
dc.identifier.issn.pt_BR.fl_str_mv 1745-6215
dc.identifier.doi.none.fl_str_mv 10.1186/s13063-021-05118-7
identifier_str_mv MAZERAUD, Aurélien et al. Effect of early treatment with polyvalent immunoglobulin on acute respiratory distress syndrome associated with SARS-CoV-2 infections (ICAR trial): study protocol for a randomized controlled trial. Trials, v. 22, n. 1, p. 1-13, 2021
1745-6215
10.1186/s13063-021-05118-7
url https://www.arca.fiocruz.br/handle/icict/50536
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv BMC
publisher.none.fl_str_mv BMC
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/50536/1/license.txt
https://www.arca.fiocruz.br/bitstream/icict/50536/2/Effect%20of%20early_Fernando_Bozza_etal_INI_2021_COVID-19.pdf
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repository.name.fl_str_mv Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv repositorio.arca@fiocruz.br
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