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Hydroxychloroquine versus placebo in the treatment of non-hospitalised patients with COVID-19 (COPE - Coalition V): A double-blind, multicentre, randomised, controlled trial.
Avezum, Álvaro; Oliveira, Gustavo B F; Oliveira, Haliton; Lucchetta, Rosa C; Pereira, Valéria F A; Dabarian, André L; D O Vieira, Ricardo; Silva, Daniel V; Kormann, Adrian P M; Tognon, Alexandre P; De Gasperi, Ricardo; Hernandes, Mauro E; Feitosa, Audes D M; Piscopo, Agnaldo; Souza, André S; Miguel, Carlos H; Nogueira, Vinicius O; Minelli, César; Magalhães, Carlos C; Morejon, Karen M L; Bicudo, Letícia S; Souza, Germano E C; Gomes, Marco A M; Fo, José J F Raposo; Schwarzbold, Alexandre V; Zilli, Alexandre; Amazonas, Roberto B; Moreira, Frederico R; Alves, Lucas B O; Assis, Silvia R L; Neves, Precil D M M; Matuoka, Jessica Y; Boszczowski, Icaro; Catarino, Daniela G M; Veiga, Viviane C; Azevedo, Luciano C P; Rosa, Regis G; Lopes, Renato D; Cavalcanti, Alexandre B; Berwanger, Otavio.
  • Avezum Á; International Research Center, Hospital Alemão Oswaldo Cruz, Rua Treze de Maio, 1815; Bloco A, 1o SS, São Paulo, SP 01327-001, Brazil.
  • Oliveira GBF; International Research Center, Hospital Alemão Oswaldo Cruz, Rua Treze de Maio, 1815; Bloco A, 1o SS, São Paulo, SP 01327-001, Brazil.
  • Oliveira H; International Research Center, Hospital Alemão Oswaldo Cruz, Rua Treze de Maio, 1815; Bloco A, 1o SS, São Paulo, SP 01327-001, Brazil.
  • Lucchetta RC; International Research Center, Hospital Alemão Oswaldo Cruz, Rua Treze de Maio, 1815; Bloco A, 1o SS, São Paulo, SP 01327-001, Brazil.
  • Pereira VFA; ALPHACOR Cardiologia Clínica e Diagnóstica, Barueri, SP, Brazil.
  • Dabarian AL; ALPHACOR Cardiologia Clínica e Diagnóstica, Barueri, SP, Brazil.
  • D O Vieira R; Hospital e Clínica São Roque, Ipiaú, BA, Brazil.
  • Silva DV; Hospital e Clínica São Roque, Ipiaú, BA, Brazil.
  • Kormann APM; AngioCor, Blumenau, SC, Brazil.
  • Tognon AP; Hospital São Vicente de Paulo, Passo Fundo, RS, Brazil.
  • De Gasperi R; Hospital Tacchini, Bento Gonçalves, RS, Brazil.
  • Hernandes ME; Santa Casa de Misericórdia de Votuporanga, Votuporanga, SP, Brazil.
  • Feitosa ADM; Pronto Socorro Cardiológico Universitário - Prof. Luiz Tavares (PROCAPE), Recife, PE, Brazil.
  • Piscopo A; Santa Casa de Misericórdia de Araras, SP, Brazil.
  • Souza AS; Santos Dumont Hospital Caraguatatuba, SP, Brazil.
  • Miguel CH; Estratégia Saúde da Família Dr. João Paccola Primo. Prefeitura Municipal, Lençois Paulista, SP, Brazil.
  • Nogueira VO; Centro de Pesquisa em Medicina Tropical de Rondônia. Porto Velho, RO, Brazil.
  • Minelli C; Hospital Carlos Fernando Malzoni. Matão, SP, Brazil.
  • Magalhães CC; Hospital Policlin. São José dos Campos, SP, Brazil.
  • Morejon KML; Hospital da Unimed. Ribeirão Preto, SP, Brazil.
  • Bicudo LS; Irmandade de Misericórdia do Hospital da Santa Casa de Monte Alto, SP, Brazil.
  • Souza GEC; Hospital Regional de São José dos Campos, SP, Brazil.
  • Gomes MAM; Centro de Pesquisas Clínicas Dr. Marco Mota, Maceió, AL, Brazil.
  • Fo JJFR; Hospital de Cordeirópolis, Cordeirópolis, SP, Brazil.
  • Schwarzbold AV; Universidade Federal de Santa Maria, Santa Maria, RS, Brazil.
  • Zilli A; Dux Medicina, Jundiaí, SP, Brazil.
  • Amazonas RB; EMS Pharma, Hortolândia, SP, Brazil.
  • Moreira FR; International Research Center, Hospital Alemão Oswaldo Cruz, Rua Treze de Maio, 1815; Bloco A, 1o SS, São Paulo, SP 01327-001, Brazil.
  • Alves LBO; International Research Center, Hospital Alemão Oswaldo Cruz, Rua Treze de Maio, 1815; Bloco A, 1o SS, São Paulo, SP 01327-001, Brazil.
  • Assis SRL; Academic Research Organization - Hospital Israelita Albert Einstein, São Paulo, SP, Brazil.
  • Neves PDMM; International Research Center, Hospital Alemão Oswaldo Cruz, Rua Treze de Maio, 1815; Bloco A, 1o SS, São Paulo, SP 01327-001, Brazil.
  • Matuoka JY; International Research Center, Hospital Alemão Oswaldo Cruz, Rua Treze de Maio, 1815; Bloco A, 1o SS, São Paulo, SP 01327-001, Brazil.
  • Boszczowski I; International Research Center, Hospital Alemão Oswaldo Cruz, Rua Treze de Maio, 1815; Bloco A, 1o SS, São Paulo, SP 01327-001, Brazil.
  • Catarino DGM; International Research Center, Hospital Alemão Oswaldo Cruz, Rua Treze de Maio, 1815; Bloco A, 1o SS, São Paulo, SP 01327-001, Brazil.
  • Veiga VC; Intensive Care Unit, BP - A Beneficência Portuguesa de São Paulo, SP, Brazil.
  • Azevedo LCP; Research and Education Institute, Hospital Sírio Libanês, São Paulo, SP, Brazil.
  • Rosa RG; Hospital Moinhos de Vento, Porto Alegre, RS, Brazil.
  • Lopes RD; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
  • Cavalcanti AB; Brazilian Clinical Research Institute, São Paulo, SP, Brazil.
  • Berwanger O; HCor Research Institute, São Paulo, SP, Brazil.
Lancet Reg Health Am ; 11: 100243, 2022 Jul.
Статья в английский | MEDLINE | ID: covidwho-1768385
ABSTRACT

Background:

Previous Randomised controlled trials (RCT) evaluating chloroquine and hydroxychloroquine in non-hospitalised COVID-19 patients have found no significant difference in hospitalisation rates. However, low statistical power precluded definitive answers.

Methods:

We conducted a multicenter, double-blind, RCT in 56 Brazilian sites. Adults with suspected or confirmed COVID-19 presenting with mild or moderate symptoms with ≤ 07 days prior to enrollment and at least one risk factor for clinical deterioration were randomised (11) to receive hydroxychloroquine 400 mg twice a day (BID) in the first day, 400 mg once daily (OD) thereafter for a total of seven days, or matching placebo. The primary outcome was hospitalisation due to COVID-19 at 30 days, which was assessed by an adjudication committee masked to treatment allocation and following the intention-to-treat (ITT) principle. An additional analysis was performed only in participants with SARS-CoV-2 infection confirmed by molecular or serology testing (modified ITT [mITT] analysis). This trial was registered at ClinicalTrials.gov, NCT04466540.

Findings:

From May 12, 2020 to July 07, 2021, 1372 patients were randomly allocated to hydroxychloroquine or placebo. There was no significant difference in the risk of hospitalisation between hydroxychloroquine and placebo groups (44/689 [6·4%] and 57/683 [8·3%], RR 0·77 [95% CI 0·52-1·12], respectively, p=0·16), and similar results were found in the mITT analysis with 43/478 [9·0%] and 55/471 [11·7%] events, RR 0·77 [95% CI 0·53-1·12)], respectively, p=0·17. To further complement our data, we conducted a meta-analysis which suggested no significant benefit of hydroxychloroquine in reducing hospitalisation among patients with positive testing (69/1222 [5·6%], and 88/1186 [7·4%]; RR 0·77 [95% CI 0·57-1·04]).

Interpretation:

In outpatients with mild or moderate forms of COVID-19, the use of hydroxychloroquine did not reduce the risk of hospitalisation compared to the placebo control. Our findings do not support the routine use of hydroxychloroquine for treatment of COVID-19 in the outpatient setting.

Funding:

COALITION COVID-19 Brazil and EMS.

Полный текст: Имеется в наличии Коллекция: Международные базы данных база данных: MEDLINE Тип исследования: Экспериментальные исследования / Прогностическое исследование / Рандомизированные контролируемые испытания / Отзывы Язык: английский Журнал: Lancet Reg Health Am Год: 2022 Тип: Статья Аффилированная страна: J.lana.2022.100243

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Полный текст: Имеется в наличии Коллекция: Международные базы данных база данных: MEDLINE Тип исследования: Экспериментальные исследования / Прогностическое исследование / Рандомизированные контролируемые испытания / Отзывы Язык: английский Журнал: Lancet Reg Health Am Год: 2022 Тип: Статья Аффилированная страна: J.lana.2022.100243