Avezum: Hydroxychloroquine versus placebo in the treatment of non-hospitalised patients with COVID-19 (COPE – Coalition V): A double-blind, multicentre, randomised, controlled trial [HCQ]

Hydroxychloroquine versus placebo in the treatment of non-hospitalised patients with COVID-19 (COPE – Coalition V): A double-blind, multicentre, randomised, controlled trial

Avezum et al., The Lancet Regional Health - Americas, doi:10.1016/j.lana.2022.100243, NCT04466540 (history)

Avezum et al., Hydroxychloroquine versus placebo in the treatment of non-hospitalised patients with COVID-19 (COPE –.., The Lancet Regional Health - Americas, doi:10.1016/j.lana.2022.100243, NCT04466540

Mar 2022 Source PDF

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Authors have not responded to a request for the data.

Outpatient RCT with 687 HCQ and 682 control patients in Brazil, showing lower hospitalization with treatment, not reaching statistical significance. Higher efficacy was seen with treatment <4 days from onset, RR 0.61. The associated meta analysis includes mostly late treatment studies, for example in [Schwartz] the median delay from onset was 7 days. [Omrani] is missing. The values for [Johnston] are incorrect - the study shows 4 hospitalizations in the control arm - RR for this study should be 0.58 instead of 0.78.

1. Johnston et al., EClinicalMedicine, doi:10.1016/j.eclinm.2021.100773 (preprint 12/9), Hydroxychloroquine with or Without Azithromycin for Treatment of Early SARS-CoV-2 Infection Among High-Risk Outpatient Adults: A Randomized Clinical Trial, https://www.thelancet.com/journals../PIIS2589-5370(21)00053-5/fulltext.

2. Omrani et al., EClinicalMedicine, doi:10.1016/j.eclinm.2020.100645, Randomized double-blinded placebo-controlled trial of hydroxychloroquine with or without azithromycin for virologic cure of non-severe Covid-19, https://www.sciencedirect.com/science/article/pii/S2589537020303898.

3. Schwartz et al., CMAJ Open, doi:10.9778/cmajo.20210069, Assessing the efficacy and safety of hydroxychloroquine as outpatient treatment of COVID-19: a randomized controlled trial, http://cmajopen.ca/content/9/2/E693.full.

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risk of death, 0.7% lower, RR 0.99, p = 1.00, treatment 5 of 687 (0.7%), control 5 of 682 (0.7%), NNT 18741, all-cause death.

risk of death, 56.0% higher, HR 1.56, p = 0.54, treatment 5 of 687 (0.7%), control 5 of 682 (0.7%), adjusted per study, univariate Firth's penalized likelihood.

risk of mechanical ventilation, 32.4% higher, RR 1.32, p = 0.79, treatment 8 of 687 (1.2%), control 6 of 682 (0.9%).

risk of ICU admission, 16.4% lower, RR 0.84, p = 0.61, treatment 16 of 687 (2.3%), control 19 of 682 (2.8%), NNT 219.

risk of hospitalization, 23.5% lower, RR 0.77, p = 0.18, treatment 44 of 689 (6.4%), control 57 of 683 (8.3%), NNT 51.

risk of hospitalization, 40.0% lower, RR 0.60, p = 0.15, treatment 267, control 265, <4 days.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Avezum et al., 31 Mar 2022, Double Blind Randomized Controlled Trial, Brazil, peer-reviewed, 40 authors, study period 12 May, 2020 - 7 July, 2021, average treatment delay 4.0 days, dosage 400mg bid day 1, 200mg bid days 2-7, trial NCT04466540 (history).

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Abstract: Articles Hydroxychloroquine versus placebo in the treatment of non-hospitalised patients with COVID-19 (COPE − Coalition V): A double-blind, multicentre, randomised, controlled trial Alvaro Avezum,a* Gustavo B F Oliveira,a Haliton Oliveira,a Rosa C Lucchetta,a Valeria F A Pereira,b Andre L Dabarian,b Ricardo DO Vieira,c Daniel V Silva,c Adrian P M Kormann,d Alexandre P Tognon,e Ricardo De Gasperi,f Mauro E Hernandes,g Audes D M Feitosa,h Agnaldo Piscopo,i Andre S Souza,j Carlos H Miguel,k Vinicius O Nogueira,l Cesar Minelli,m Carlos C Magalh~ aes,n Karen M L Morejon,o Letícia S Bicudo,p Germano E C Souza,q Marco A M Gomes,r Jose J F Raposo Fo,s Alexandre V Schwarzbold,t Alexandre Zilli,u Roberto B Amazonas,v Frederico R Moreira,a Lucas B O Alves,a Silvia R L Assis,ac Precil D M M Neves,a Jessica Y Matuoka,a Icaro Boszczowski,a Daniela G M Catarino,a Viviane C Veiga,w Luciano C P Azevedo,x Regis G Rosa,y Renato D Lopes,z,aa Alexandre B Cavalcanti,ab and Otavio Berwanger ac, on behalf of the COPE - COALITION COVID-19 Brazil V Investigators 1 a International Research Center, Hospital Alem~ao Oswaldo Cruz, Rua Treze de Maio, 1815; Bloco A, 1o SS, S~ao Paulo, SP 01327-001, Brazil b stica, Barueri, SP, Brazil ALPHACOR Cardiologia Clínica e Diagno c Hospital e Clínica S~ao Roque, Ipia u, BA, Brazil d AngioCor, Blumenau, SC, Brazil e Hospital S~ao Vicente de Paulo, Passo Fundo, RS, Brazil f Hospital Tacchini, Bento Gonçalves, RS, Brazil g rdia de Votuporanga, Votuporanga, SP, Brazil Santa Casa de Miserico h Pronto Socorro Cardiol ogico Universitario - Prof. Luiz Tavares (PROCAPE), Recife, PE, Brazil i rdia de Araras, SP, Brazil Santa Casa de Miserico j Santos Dumont Hospital Caraguatatuba, SP, Brazil k Estrategia Sa ude da Família Dr. Jo~ao Paccola Primo. Prefeitura Municipal, Lençois Paulista, SP, Brazil l Centro de Pesquisa em Medicina Tropical de Rond^ onia. Porto Velho, RO, Brazil m Hospital Carlos Fernando Malzoni. Mat~ao, SP, Brazil n Hospital Policlin. S~ao Jos e dos Campos, SP, Brazil o Hospital da Unimed. Ribeir~ao Preto, SP, Brazil p Irmandade de Miseric ordia do Hospital da Santa Casa de Monte Alto, SP, Brazil q Hospital Regional de S~ao Jos e dos Campos, SP, Brazil r Centro de Pesquisas Clínicas Dr. Marco Mota, Macei o, AL, Brazil s polis, Cordeiro polis, SP, Brazil Hospital de Cordeiro t Universidade Federal de Santa Maria, Santa Maria, RS, Brazil u Dux Medicina, Jundiaí, SP, Brazil v EMS Pharma, Hortol^andia, SP, Brazil w Intensive Care Unit, BP − A Beneﬁc^ encia Portuguesa de S~ao Paulo, SP, Brazil x Research and Education Institute, Hospital Sírio Liban^ es, S~ao Paulo, SP, Brazil y Hospital Moinhos de Vento, Porto Alegre, RS, Brazil z Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA aa Brazilian Clinical Research Institute, S~ao Paulo, SP, Brazil ab HCor Research Institute, S~ao Paulo, SP, Brazil ac Academic Research Organization - Hospital Israelita Albert Einstein, S~ao Paulo, SP, Brazil Summary Background Previous Randomised controlled trials (RCT) evaluating chloroquine and hydroxychloroquine in nonhospitalised COVID-19 patients have found no significant difference in hospitalisation rates. However, low statistical power precluded definitive answers. The Lancet Regional Health - Americas 2022;11: 100243 Published online xxx https://doi.org/10.1016/j. lana.2022.100243 *Corresponding author. Avezum). E-mail address: aavezum@haoc.com.br (A. 1 COPE - COALITION..

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