Hydroxychloroquine versus placebo in the treatment of non-hospitalised patients with COVID-19 (COPE – Coalition V): A double-blind, multicentre, randomised, controlled trial
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.
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.
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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.
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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%).
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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.
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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.
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risk of hospitalization, 40.0% lower, RR 0.60, p = 0.15, treatment 267, control 265, <4 days.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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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).
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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treatments are complementary. All practical, effective, and safe means should
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