Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study)

Borba, Mayla Gabriela Silva; Val, Fernando Fonseca Almeida; Sampaio, Vanderson Souza; Alexandre, Marcia Almeida Araújo; Melo, Gisely Cardoso; Brito, Marcelo; Mourão, Maria Paula Gomes; Brito-Sousa, José Diego; Baía-da-Silva, Djane; Guerra, Marcus Vinitius Farias; Hajjar, Ludhmila Abrahão; Pinto, Rosemary Costa; Balieiro, Antonio Alcirley Silva; Naveca, Felipe Gomes; Xavier, Mariana Simão; Salomão, Alexandre; Siqueira, André Machado; Schwarzbolt, Alexandre; Croda, Júlio Henrique Rosa; Nogueira, Maurício Lacerda; Romero, Gustavo Adolfo Sierra; Bassat, Quique; Fontes, Cor Jesus; Albuquerque, Bernardino Cláudio; Daniel-Ribeiro, Cláudio Tadeu; Monteiro, Wuelton Marcelo; Lacerda, Marcus Vinícius Guimarães; CloroCovid-19 Team

Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study)

Detalhes bibliográficos
Autor(a) principal:	Borba, Mayla Gabriela Silva
Data de Publicação:	2020
Outros Autores:	Val, Fernando Fonseca Almeida, Sampaio, Vanderson Souza, Alexandre, Marcia Almeida Araújo, Melo, Gisely Cardoso, Brito, Marcelo, Mourão, Maria Paula Gomes, Brito-Sousa, José Diego, Baía-da-Silva, Djane, Guerra, Marcus Vinitius Farias, Hajjar, Ludhmila Abrahão, Pinto, Rosemary Costa, Balieiro, Antonio Alcirley Silva, Naveca, Felipe Gomes, Xavier, Mariana Simão, Salomão, Alexandre, Siqueira, André Machado, Schwarzbolt, Alexandre, Croda, Júlio Henrique Rosa, Nogueira, Maurício Lacerda, Romero, Gustavo Adolfo Sierra, Bassat, Quique, Fontes, Cor Jesus, Albuquerque, Bernardino Cláudio, Daniel-Ribeiro, Cláudio Tadeu, Monteiro, Wuelton Marcelo, Lacerda, Marcus Vinícius Guimarães, CloroCovid-19 Team
Tipo de documento:	Artigo
Idioma:	eng
Título da fonte:	Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo:	https://www.arca.fiocruz.br/handle/icict/40857
Resumo:	This article is a preprint and has not been certified by peer review [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.

Metadados do item

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network_acronym_str	CRUZ
network_name_str	Repositório Institucional da FIOCRUZ (ARCA)
repository_id_str	2135
spelling	Borba, Mayla Gabriela SilvaVal, Fernando Fonseca AlmeidaSampaio, Vanderson SouzaAlexandre, Marcia Almeida AraújoMelo, Gisely CardosoBrito, MarceloMourão, Maria Paula GomesBrito-Sousa, José DiegoBaía-da-Silva, DjaneGuerra, Marcus Vinitius FariasHajjar, Ludhmila AbrahãoPinto, Rosemary CostaBalieiro, Antonio Alcirley SilvaNaveca, Felipe GomesXavier, Mariana SimãoSalomão, AlexandreSiqueira, André MachadoSchwarzbolt, AlexandreCroda, Júlio Henrique RosaNogueira, Maurício LacerdaRomero, Gustavo Adolfo SierraBassat, QuiqueFontes, Cor JesusAlbuquerque, Bernardino CláudioDaniel-Ribeiro, Cláudio TadeuMonteiro, Wuelton MarceloLacerda, Marcus Vinícius GuimarãesCloroCovid-19 Team2020-04-19T00:45:58Z2020-04-19T00:45:58Z2020BORBA, Mayla Gabriela Silva et al. Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study). MedRxiv, p. 1-30, 2020.https://www.arca.fiocruz.br/handle/icict/4085710.1101/2020.04.07.20056424This article is a preprint and has not been certified by peer review [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.All relevant ethical guidelines have been followed; any necessary IRB and/or ethics committee approvals have been obtained and details of the IRB/oversight body are included in the manuscript. Yes. All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes. I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes. I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.CloroCovid-19 Team (in alphabetical order): Adria Lemos Vasconcelos, Adriana Ferreira Praia Marins, Ágatha Kelly Araújo Costa, Alex Bezerra Silva Maciel, Alexandre Oliveira Trindade, Andiana Souza Dias, André Lima Guerra Corado, Anna Gabriela Rezende Santos, Antônio Guilherme Fonseca Pacheco, Antonny Michael Silva Sousa, Bleno Leonam Gonçalves Costa, Carlos Eduardo Padron Morais, Caroline Santos Soares, Debora Camila Gomes Duarte, Christiane Maria Prado Jeronimo, Ejandre Garcia Negreiros Silva, Elisângela Fátima Ponte Frota, Emanuel Medeiros Marinho Almeida, Emanuelle Lira Silva, Erick Frota Gomes Figueiredo, Fábio Manabu Martins Shimizu, Fabíola Ramalho Ferreira Souza, Fernando Hugo Jesus Fonseca, Flor Ernestina Martinez-Espinosa, Gabrielle Silva Pereira, Hilda Ferreira Melo, Ingrid Nascimento Oliveira, James Dean Oliveira Santos Jr, João Ricardo Silva Neto, Josué Nélio Brutus, Kelry Mazurega Oliveira Dinelly, Laleyska Deucylane Costa Rodrigues, Larissa Esthefani Barros Cirino, Lorenna Pereira Souza, Lucas Barbosa Oliveira, Luiz Carlos Lima Ferreira, Luiz Henrique Gonçalves Maciel, Maria Eduarda Leão Farias, Monique Freire, Nagila Morais Rocha, Natália Guedes Melo Silva, Raíssa Soares Freire, Rebeca Linhares Abreu-Netto, Rodrigo Saboia Lima, Rosângela Francisca Tanantas Melo, Rossicleia Lins Monte, Sheila Vitor-Silva, Thaliê Cavalcante Santos, Valdinete Alves Nascimento, Vitória Silva Printes, Wanessa Pessoa Sousa Barbosa.This study was funded by the Government of the Amazonas State, Farmanguinhos (Fiocruz), SUFRAMA, CAPES, FAPEAM, and federal funds granted by a coalition of Brazilian senators.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Faculdade de Medicina da Universidade de São Paulo. São Paulo, SP, Brasil.Fundação de Vigilância em Saúde do Amazonas. Manaus, AM, Brasil.Fundação Oswaldo Cruz. Instituto Leônidas & Maria Deane. Manaus, AM, Brasil.Fundação Oswaldo Cruz. Instituto Leônidas & Maria Deane. Manaus, AM, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Carlos Chagas. Rio de Janeiro, RJ, Brasil.Hospital Santa Júlia. Manaus, AM, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Carlos Chagas. Rio de Janeiro, RJ, Brasil.Universidade Federal de Santa Maria. Rio Grande do Sul, RS, Brasil.Faculdade de Medicina da Universidade Federal do Mato Grosso do Sul. Campo Grande, MS, Brasil / Fundação Oswaldo Cruz. Fiocruz Mato Grosso do Sul. Campo Grande, MS, Brasil.Faculdade de Medicina de São José do Rio Preto. São José do Rio Preto, SP, Brasil.Universidade de Brasília. Brasília, DF, Brasil.ISGlobal. Hospital Clínic–Universitat de Barcelona. Barcelona, Spain / Centro de Investigação em Saúde de Manhiça. Maputo, Mozambique / ICREA. Barcelona, Spain / University of Barcelona. Hospital Sant Joan de Déu. Pediatrics Department. Pediatric Infectious Diseases Unit. Barcelona, Spain / Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública. Madrid, Spain.Universidade Federal de Mato Grosso. Cuiabá, MT, Brasil.Universidade Federal do Amazonas. Faculdade de Medicina. Manaus, AM, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Rio de Janeiro, RJ, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Manaus, AM, Brasil / Universidade do Estado do Amazonas. Manaus, AM, Brasil / Fundação Oswaldo Cruz. Instituto Leônidas & Maria Deane. Manaus, AM, Brasil.Background There is no specific antiviral therapy recommended for the disease caused by SARS-CoV-2 (COVID-19). Recent publications have drawn attention to the possible benefit of chloroquine (CQ). Our study aimed to comprehensively evaluate the safety and efficacy of two different CQ dosages in patients with established severe COVID-19. Methods We performed a parallel, double-blinded, randomized, phase IIb clinical trial, aiming to assess safety and efficacy of two different CQ dosages as adjunctive therapy of hospitalized patients with SARS in Manaus, Brazilian Amazon. Eligible participants were allocated to receive orally or via nasogastric tube high dose CQ (600mg CQ twice daily for 10 days or total dose 12g); or low dose CQ (450mg for 5 days, twice daily only on the first day, or total dose 2.7g). In addition, all patients received ceftriaxone and azithromycin. This study was registered with ClinicalTrials.gov, number NCT04323527. Findings Out of a pre-defined 440 patients sample size, 81 patients were enrolled. The high dose CQ arm presented more QTc>500ms (25%), and a trend toward higher lethality (17%) than the lower dosage. Fatality rate was 13.5% (95%CI=6.9-23.0%), overlapping with the CI of historical data from similar patients not using CQ (95%CI=14.5-19.2%). In 14 patients with paired samples, respiratory secretion at day 4 was negative in only one patient. Interpretation Preliminary findings suggest that the higher CQ dosage (10-day regimen) should not be recommended for COVID-19 treatment because of its potential safety hazards. Such results forced us to prematurely halt patient recruitment to this arm. Given the enormous global push for the use of CQ for COVID-19, results such as the ones found in this trial can provide robust evidence for updated COVID-19 patient management recommendations.engCOVID-19ChloroquinaSARS-CoV-2CoronavírusCOVID-19Chloroquine diphosphateTherapy of hospitalized patientsSARS-CoV-2CloroCOVID-19 StudyChloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study)info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; 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dc.title.pt_BR.fl_str_mv	Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study)
title	Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study)
spellingShingle	Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study) Borba, Mayla Gabriela Silva COVID-19 Chloroquina SARS-CoV-2 Coronavírus COVID-19 Chloroquine diphosphate Therapy of hospitalized patients SARS-CoV-2 CloroCOVID-19 Study
title_short	Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study)
title_full	Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study)
title_fullStr	Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study)
title_full_unstemmed	Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study)
title_sort	Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study)
author	Borba, Mayla Gabriela Silva
author_facet	Borba, Mayla Gabriela Silva Val, Fernando Fonseca Almeida Sampaio, Vanderson Souza Alexandre, Marcia Almeida Araújo Melo, Gisely Cardoso Brito, Marcelo Mourão, Maria Paula Gomes Brito-Sousa, José Diego Baía-da-Silva, Djane Guerra, Marcus Vinitius Farias Hajjar, Ludhmila Abrahão Pinto, Rosemary Costa Balieiro, Antonio Alcirley Silva Naveca, Felipe Gomes Xavier, Mariana Simão Salomão, Alexandre Siqueira, André Machado Schwarzbolt, Alexandre Croda, Júlio Henrique Rosa Nogueira, Maurício Lacerda Romero, Gustavo Adolfo Sierra Bassat, Quique Fontes, Cor Jesus Albuquerque, Bernardino Cláudio Daniel-Ribeiro, Cláudio Tadeu Monteiro, Wuelton Marcelo Lacerda, Marcus Vinícius Guimarães CloroCovid-19 Team
author_role	author
author2	Val, Fernando Fonseca Almeida Sampaio, Vanderson Souza Alexandre, Marcia Almeida Araújo Melo, Gisely Cardoso Brito, Marcelo Mourão, Maria Paula Gomes Brito-Sousa, José Diego Baía-da-Silva, Djane Guerra, Marcus Vinitius Farias Hajjar, Ludhmila Abrahão Pinto, Rosemary Costa Balieiro, Antonio Alcirley Silva Naveca, Felipe Gomes Xavier, Mariana Simão Salomão, Alexandre Siqueira, André Machado Schwarzbolt, Alexandre Croda, Júlio Henrique Rosa Nogueira, Maurício Lacerda Romero, Gustavo Adolfo Sierra Bassat, Quique Fontes, Cor Jesus Albuquerque, Bernardino Cláudio Daniel-Ribeiro, Cláudio Tadeu Monteiro, Wuelton Marcelo Lacerda, Marcus Vinícius Guimarães CloroCovid-19 Team
author2_role	author author author author author author author author author author author author author author author author author author author author author author author author author author author
dc.contributor.author.fl_str_mv	Borba, Mayla Gabriela Silva Val, Fernando Fonseca Almeida Sampaio, Vanderson Souza Alexandre, Marcia Almeida Araújo Melo, Gisely Cardoso Brito, Marcelo Mourão, Maria Paula Gomes Brito-Sousa, José Diego Baía-da-Silva, Djane Guerra, Marcus Vinitius Farias Hajjar, Ludhmila Abrahão Pinto, Rosemary Costa Balieiro, Antonio Alcirley Silva Naveca, Felipe Gomes Xavier, Mariana Simão Salomão, Alexandre Siqueira, André Machado Schwarzbolt, Alexandre Croda, Júlio Henrique Rosa Nogueira, Maurício Lacerda Romero, Gustavo Adolfo Sierra Bassat, Quique Fontes, Cor Jesus Albuquerque, Bernardino Cláudio Daniel-Ribeiro, Cláudio Tadeu Monteiro, Wuelton Marcelo Lacerda, Marcus Vinícius Guimarães CloroCovid-19 Team
dc.subject.other.pt_BR.fl_str_mv	COVID-19 Chloroquina SARS-CoV-2 Coronavírus
topic	COVID-19 Chloroquina SARS-CoV-2 Coronavírus COVID-19 Chloroquine diphosphate Therapy of hospitalized patients SARS-CoV-2 CloroCOVID-19 Study
dc.subject.en.pt_BR.fl_str_mv	COVID-19 Chloroquine diphosphate Therapy of hospitalized patients SARS-CoV-2 CloroCOVID-19 Study
description	This article is a preprint and has not been certified by peer review [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.
publishDate	2020
dc.date.accessioned.fl_str_mv	2020-04-19T00:45:58Z
dc.date.available.fl_str_mv	2020-04-19T00:45:58Z
dc.date.issued.fl_str_mv	2020
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	BORBA, Mayla Gabriela Silva et al. Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study). MedRxiv, p. 1-30, 2020.
dc.identifier.uri.fl_str_mv	https://www.arca.fiocruz.br/handle/icict/40857
dc.identifier.doi.pt_BR.fl_str_mv	10.1101/2020.04.07.20056424
identifier_str_mv	BORBA, Mayla Gabriela Silva et al. Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study). MedRxiv, p. 1-30, 2020. 10.1101/2020.04.07.20056424
url	https://www.arca.fiocruz.br/handle/icict/40857
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.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/40857/1/license.txt https://www.arca.fiocruz.br/bitstream/icict/40857/2/Borba_Mayla_ILMD_2020COVID19.pdf https://www.arca.fiocruz.br/bitstream/icict/40857/3/Borba_Mayla_ILMD_2020COVID19.pdf.txt
bitstream.checksum.fl_str_mv	0ab46789d568c4ba27c7b5d29a9fe9c4 61c87190b95daabcd51805ed2383ac46 12f57d1346416e970c1d8ef161fb3450
bitstream.checksumAlgorithm.fl_str_mv	MD5 MD5 MD5
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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Chloroquine diphosphate in two different dosages as adjunctive therapy of hospitalized patients with severe respiratory syndrome in the context of coronavirus (SARS-CoV-2) infection: Preliminary safety results of a randomized, double-blinded, phase IIb clinical trial (CloroCovid-19 Study)

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