Produção Nacional
Revisado por pares
Hydroxychloroquine versus placebo in the treatment of non-hospitalised patients with COVID-19 (COPE – Coalition V): A double-blind, multicentre, randomised, controlled trial
2022; Elsevier BV; Volume: 11; Linguagem: Inglês
10.1016/j.lana.2022.100243
ISSN2667-193X
AutoresÁlvaro Avezum, Gustavo B.F. Oliveira, Haliton Alves de Oliveira, Rosa Camila Lucchetta, Valéria F A Pereira, André Dabarian, Ricardo D ́O Vieira, Daniel Valadão Silva, Adrian Kormann, Alexandre Pereira Tognon, Ricardo de Gasperi, Mauro Esteves Hernandes, Audes D. M. Feitosa, Agnaldo Piscopo, Andre Silva Souza, Carlos H Miguel, Vinicius Ortigosa Nogueira, César Minelli, Carlos Costa Magalhães, Karen Mirna Loro Morejón, Letícia S Bicudo, Germano E C Souza, Marco Antônio Mota Gomes, Jose J.F. Raposo Filho, Alexandre Vargas Schwarzbold, Alexandre Cabral Zilli, Roberto Bleuel Amazonas, Frederico Rafael Moreira, Lucas Bassolli de Oliveira Alves, Silvia Regina Lamas Assis, Precil Diego Miranda de Menezes Neves, Jéssica Yumi Matuoka, Icaro Boszczowski, Daniela Ghidetti Mangas Catarino, Viviane Cordeiro Veiga, Luciano César Pontes Azevedo, Régis Goulart Rosa, Renato D. Lópes, Alexandre Biasi Cavalcanti, Otávio Berwanger,
Tópico(s)Pharmacological Receptor Mechanisms and Effects
ResumoPrevious 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.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 (1:1) 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.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]).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.COALITION COVID-19 Brazil and EMS.
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