Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Randomized Clinical Trial
| Autor(a) principal: | |
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| Data de Publicação: | 2020 |
| Outros Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
| Texto Completo: | https://www.arca.fiocruz.br/handle/icict/40984 |
Resumo: | Fundação de Medicina Tropical Dr Heitor Vieira Dourado. Manaus, AM, Brasil. |
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Borba, Mayla Gabriela SilvaVal, Fernando Fonseca AlmeidaSampaio, Vanderson SouzaAlexandre, Marcia Almeida AraújoMelo, Gisely CardosoBrito, MarceloMourão, Maria Paula GomesSousa, José Diego BritoSilva, Djane Baia daGuerra, Marcus Vinitius FariasHajjar, Ludhmila AbrahãoPinto, Rosemary CostaBalieiro, Antonio Alcirley SilvaPacheco, Antônio Guilherme FonsecaSantos Jr., James Dean OliveiraNaveca, Felipe GomesXavier, Mariana SimãoSiqueira, André MachadoSchwarzbold, AlexandreCroda, JúlioNogueira, Maurício LacerdaRomero, Gustavo Adolfo SierraBassat, QuiqueFontes, Cor JesusAlbuquerque, Bernardino CláudioDaniel-Ribeiro, Cláudio TadeuMonteiro, Wuelton MarceloLacerda, Marcus Vinícius GuimarãesCloroCovid-19 Team2020-04-27T14:57:45Z2020-04-27T14:57:45Z2020BORBA, Mayla Gabiela Silva et al. Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection A Randomized Clinical Trial. JAMA Network Open, v. 3, (4.23), e 208857, p. 1-14, Apr. 2020.2574-3805https://www.arca.fiocruz.br/handle/icict/4098410.1001/jamanetworkopen.2020.8857engJAMA NetworkSARS-CoV-2Difosfato de cloroquinaTerapia AdjuntaPacientesEnsaio Clínico RandomizadoDoses altas versus baixasCOVID-19CoronavírusSARS-CoV-2Chloroquine DiphosphateAdjunctive TherapyPatientsRandomized Clinical TrialHigh vs Low DosesCOVID-19CoronavirusEffect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Randomized Clinical Trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFundação 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.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.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.Fundação de Medicina Tropical Dr Heitor Vieira Dourado. Manaus, AM, Brasil.Universidade de São Paulo. Faculdade de Medicina. São Paulo, SP, Brasil.Fundação de Vigilância em Saúde do Amazonas, Manaus, AN, Brasil.Fundação Oswaldo Cruz. Instituto Leônidas and Maria Deane. Manaus, AM, Brasil.Fundação Oswaldo Cruz. Presidência. Programa de Computação Científica. Rio de janeiro, RJ, Brasil.Universidade Federal do Amazonas, Manaus, AM, Brasil.Fundação Oswaldo Cruz. Instituto Leônidas and Maria Deane. Manaus, AM, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Carlos Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Carlos Chagas. Rio de Janeiro, RJ, Brasil.Universidade Federal de Santa Maria. Santa Maria, RS, Brasil.Universidade Federal de Santa Maria. Santa Maria, RS, Brasil / Fundação Oswaldo Cruz. 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 / Pediatric Infectious Diseases Unit, Pediatrics Department, Hospital Sant Joan de Déu, University of Barcelona. Barcelona, Spain / Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública. Madrid, SpainUniversidade Federal de Mato Grosso. Campo Grande, 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.Fundação de Medicina Tropical Dr Heitor Vieira Dourado. Manaus, AM, Brasil.Fundação de Medicina Tropical Dr Heitor Vieira Dourado. Manaus, AM, Brasil.COVID TeamThere is no specific antiviral therapy recommended for coronavirus disease 2019 (COVID-19). In vitro studies indicate that the antiviral effect of chloroquine diphosphate (CQ) requires a high concentration of the drug. OBJECTIVE To evaluate the safety and efficacy of 2 CQ dosages in patients with severe COVID-19. IMPORTANCE There is no specific antiviral therapy recommended for coronavirus disease 2019 (COVID-19). In vitro studies indicate that the antiviral effect of chloroquine diphosphate (CQ) requires a high concentration of the drug. OBJECTIVE To evaluate the safety and efficacy of 2 CQ dosages in patients with severe COVID-19. DESIGN, SETTING, AND PARTICIPANTS This parallel, double-masked, randomized, phase IIb clinical trial with 81 adult patients who were hospitalized with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was conducted from March 23 to April 5, 2020, at a tertiary care facility in Manaus, Brazilian Amazon. INTERVENTIONS Patients were allocated to receive high-dosage CQ (ie, 600 mg CQ twice daily for 10 days) or low-dosage CQ (ie, 450 mg twice daily on day 1 and once daily for 4 days). MAIN OUTCOMES AND MEASURES Primary outcome was reduction in lethality by at least 50% in the high-dosage group compared with the low-dosage group. Data presented here refer primarily to safety and lethality outcomes during treatment on day 13. Secondary end points included participant clinical status, laboratory examinations, and electrocardiogram results. Outcomes will be presented to day 28. Viral respiratory secretion RNA detection was performed on days 0 and 4. RESULTS Out of a predefined sample size of 440 patients, 81 were enrolled (41 [50.6%] to highdosage group and 40 [49.4%] to low-dosage group). Enrolled patients had a mean (SD) age of 51.1 (13.9) years, and most (60 [75.3%]) were men. Older age (mean [SD] age, 54.7 [13.7] years vs 47.4 [13.3] years) and more heart disease (5 of 28 [17.9%] vs 0) were seen in the high-dose group. Viral RNA was detected in 31 of 40 (77.5%) and 31 of 41 (75.6%) patients in the low-dosage and highdosage groups, respectively. Lethality until day 13 was 39.0% in the high-dosage group (16 of 41) and 15.0% in the low-dosage group (6 of 40). The high-dosage group presented more instance of QTc interval greater than 500 milliseconds (7 of 37 [18.9%]) compared with the low-dosage group (4 of 36 [11.1%]). Respiratory secretion at day 4 was negative in only 6 of 27 patients (22.2%). CONCLUSIONS AND RELEVANCE The preliminary findings of this study suggest that the higher CQ dosage should not be recommended for critically ill patients with COVID-19 because of its potential safety hazards, especially when taken concurrently with azithromycin and oseltamivir. These findings cannot be extrapolated to patients with nonsevere COVID-19. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT04323527.info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83134https://www.arca.fiocruz.br/bitstream/icict/40984/1/license.txt0ab46789d568c4ba27c7b5d29a9fe9c4MD51ORIGINALBorba_Mayla_etal_IOC_PROCC_ILMD_2020.pdfBorba_Mayla_etal_IOC_PROCC_ILMD_2020.pdfapplication/pdf1052390https://www.arca.fiocruz.br/bitstream/icict/40984/2/Borba_Mayla_etal_IOC_PROCC_ILMD_2020.pdfb44fb64407955fcfca87e54767146a96MD52TEXTBorba_Mayla_etal_IOC_PROCC_ILMD_2020.pdf.txtBorba_Mayla_etal_IOC_PROCC_ILMD_2020.pdf.txtExtracted texttext/plain62085https://www.arca.fiocruz.br/bitstream/icict/40984/3/Borba_Mayla_etal_IOC_PROCC_ILMD_2020.pdf.txt0dbc0b49d932080c1f8c8e16ba2ed4fcMD53icict/409842020-05-06 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| dc.title.pt_BR.fl_str_mv |
Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Randomized Clinical Trial |
| title |
Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Randomized Clinical Trial |
| spellingShingle |
Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Randomized Clinical Trial Borba, Mayla Gabriela Silva SARS-CoV-2 Difosfato de cloroquina Terapia Adjunta Pacientes Ensaio Clínico Randomizado Doses altas versus baixas COVID-19 Coronavírus SARS-CoV-2 Chloroquine Diphosphate Adjunctive Therapy Patients Randomized Clinical Trial High vs Low Doses COVID-19 Coronavirus |
| title_short |
Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Randomized Clinical Trial |
| title_full |
Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Randomized Clinical Trial |
| title_fullStr |
Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Randomized Clinical Trial |
| title_full_unstemmed |
Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Randomized Clinical Trial |
| title_sort |
Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection: A Randomized Clinical Trial |
| 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 Sousa, José Diego Brito Silva, Djane Baia da Guerra, Marcus Vinitius Farias Hajjar, Ludhmila Abrahão Pinto, Rosemary Costa Balieiro, Antonio Alcirley Silva Pacheco, Antônio Guilherme Fonseca Santos Jr., James Dean Oliveira Naveca, Felipe Gomes Xavier, Mariana Simão Siqueira, André Machado Schwarzbold, Alexandre Croda, Júlio 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 Sousa, José Diego Brito Silva, Djane Baia da Guerra, Marcus Vinitius Farias Hajjar, Ludhmila Abrahão Pinto, Rosemary Costa Balieiro, Antonio Alcirley Silva Pacheco, Antônio Guilherme Fonseca Santos Jr., James Dean Oliveira Naveca, Felipe Gomes Xavier, Mariana Simão Siqueira, André Machado Schwarzbold, Alexandre Croda, Júlio 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 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 Sousa, José Diego Brito Silva, Djane Baia da Guerra, Marcus Vinitius Farias Hajjar, Ludhmila Abrahão Pinto, Rosemary Costa Balieiro, Antonio Alcirley Silva Pacheco, Antônio Guilherme Fonseca Santos Jr., James Dean Oliveira Naveca, Felipe Gomes Xavier, Mariana Simão Siqueira, André Machado Schwarzbold, Alexandre Croda, Júlio 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 |
SARS-CoV-2 Difosfato de cloroquina Terapia Adjunta Pacientes Ensaio Clínico Randomizado Doses altas versus baixas COVID-19 Coronavírus |
| topic |
SARS-CoV-2 Difosfato de cloroquina Terapia Adjunta Pacientes Ensaio Clínico Randomizado Doses altas versus baixas COVID-19 Coronavírus SARS-CoV-2 Chloroquine Diphosphate Adjunctive Therapy Patients Randomized Clinical Trial High vs Low Doses COVID-19 Coronavirus |
| dc.subject.en.pt_BR.fl_str_mv |
SARS-CoV-2 Chloroquine Diphosphate Adjunctive Therapy Patients Randomized Clinical Trial High vs Low Doses COVID-19 Coronavirus |
| description |
Fundação de Medicina Tropical Dr Heitor Vieira Dourado. Manaus, AM, Brasil. |
| publishDate |
2020 |
| dc.date.accessioned.fl_str_mv |
2020-04-27T14:57:45Z |
| dc.date.available.fl_str_mv |
2020-04-27T14:57:45Z |
| 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 Gabiela Silva et al. Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection A Randomized Clinical Trial. JAMA Network Open, v. 3, (4.23), e 208857, p. 1-14, Apr. 2020. |
| dc.identifier.uri.fl_str_mv |
https://www.arca.fiocruz.br/handle/icict/40984 |
| dc.identifier.issn.pt_BR.fl_str_mv |
2574-3805 |
| dc.identifier.doi.none.fl_str_mv |
10.1001/jamanetworkopen.2020.8857 |
| identifier_str_mv |
BORBA, Mayla Gabiela Silva et al. Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection A Randomized Clinical Trial. JAMA Network Open, v. 3, (4.23), e 208857, p. 1-14, Apr. 2020. 2574-3805 10.1001/jamanetworkopen.2020.8857 |
| url |
https://www.arca.fiocruz.br/handle/icict/40984 |
| dc.language.iso.fl_str_mv |
eng |
| language |
eng |
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info:eu-repo/semantics/openAccess |
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openAccess |
| dc.publisher.none.fl_str_mv |
JAMA Network |
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JAMA Network |
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reponame:Repositório Institucional da FIOCRUZ (ARCA) instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
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Fundação Oswaldo Cruz (FIOCRUZ) |
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FIOCRUZ |
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FIOCRUZ |
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Repositório Institucional da FIOCRUZ (ARCA) |
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Repositório Institucional da FIOCRUZ (ARCA) |
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https://www.arca.fiocruz.br/bitstream/icict/40984/1/license.txt https://www.arca.fiocruz.br/bitstream/icict/40984/2/Borba_Mayla_etal_IOC_PROCC_ILMD_2020.pdf https://www.arca.fiocruz.br/bitstream/icict/40984/3/Borba_Mayla_etal_IOC_PROCC_ILMD_2020.pdf.txt |
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MD5 MD5 MD5 |
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Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ) |
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repositorio.arca@fiocruz.br |
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1813009067706155008 |