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The Capital Region of Denmark - a part of Copenhagen University Hospital
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Mortality outcomes with hydroxychloroquine and chloroquine in COVID-19 from an international collaborative meta-analysis of randomized trials

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  • Cathrine Axfors
  • Andreas M Schmitt
  • Perrine Janiaud
  • Janneke Van't Hooft
  • Sherief Abd-Elsalam
  • Ehab F Abdo
  • Benjamin S Abella
  • Javed Akram
  • Ravi K Amaravadi
  • Derek C Angus
  • Yaseen M Arabi
  • Shehnoor Azhar
  • Lindsey R Baden
  • Arthur W Baker
  • Leila Belkhir
  • Thomas Benfield
  • Marvin A H Berrevoets
  • Cheng-Pin Chen
  • Tsung-Chia Chen
  • Shu-Hsing Cheng
  • Chien-Yu Cheng
  • Wei-Sheng Chung
  • Yehuda Z Cohen
  • Lisa N Cowan
  • Olav Dalgard
  • Fernando F de Almeida E Val
  • Marcus V G de Lacerda
  • Gisely C de Melo
  • Lennie Derde
  • Vincent Dubee
  • Anissa Elfakir
  • Anthony C Gordon
  • Carmen M Hernandez-Cardenas
  • Thomas Hills
  • Andy I M Hoepelman
  • Yi-Wen Huang
  • Bruno Igau
  • Ronghua Jin
  • Felipe Jurado-Camacho
  • Khalid S Khan
  • Peter G Kremsner
  • Benno Kreuels
  • Cheng-Yu Kuo
  • Thuy Le
  • Yi-Chun Lin
  • Wu-Pu Lin
  • Tse-Hung Lin
  • Magnus Nakrem Lyngbakken
  • Colin McArthur
  • Bryan J McVerry
  • Patricia Meza-Meneses
  • Wuelton M Monteiro
  • Susan C Morpeth
  • Ahmad Mourad
  • Mark J Mulligan
  • Srinivas Murthy
  • Susanna Naggie
  • Shanti Narayanasamy
  • Alistair Nichol
  • Lewis A Novack
  • Sean M O'Brien
  • Nwora Lance Okeke
  • Léna Perez
  • Rogelio Perez-Padilla
  • Laurent Perrin
  • Arantxa Remigio-Luna
  • Norma E Rivera-Martinez
  • Frank W Rockhold
  • Sebastian Rodriguez-Llamazares
  • Robert Rolfe
  • Rossana Rosa
  • Helge Røsjø
  • Vanderson S Sampaio
  • Todd B Seto
  • Muhammad Shehzad
  • Shaimaa Soliman
  • Jason E Stout
  • Ireri Thirion-Romero
  • Andrea B Troxel
  • Ting-Yu Tseng
  • Nicholas A Turner
  • Robert J Ulrich
  • Stephen R Walsh
  • Steve A Webb
  • Jesper M Weehuizen
  • Maria Velinova
  • Hon-Lai Wong
  • Rebekah Wrenn
  • Fernando G Zampieri
  • Wu Zhong
  • David Moher
  • Steven N Goodman
  • John P A Ioannidis
  • Lars G Hemkens
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Substantial COVID-19 research investment has been allocated to randomized clinical trials (RCTs) on hydroxychloroquine/chloroquine, which currently face recruitment challenges or early discontinuation. We aim to estimate the effects of hydroxychloroquine and chloroquine on survival in COVID-19 from all currently available RCT evidence, published and unpublished. We present a rapid meta-analysis of ongoing, completed, or discontinued RCTs on hydroxychloroquine or chloroquine treatment for any COVID-19 patients (protocol: https://osf.io/QESV4/ ). We systematically identified unpublished RCTs (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, Cochrane COVID-registry up to June 11, 2020), and published RCTs (PubMed, medRxiv and bioRxiv up to October 16, 2020). All-cause mortality has been extracted (publications/preprints) or requested from investigators and combined in random-effects meta-analyses, calculating odds ratios (ORs) with 95% confidence intervals (CIs), separately for hydroxychloroquine and chloroquine. Prespecified subgroup analyses include patient setting, diagnostic confirmation, control type, and publication status. Sixty-three trials were potentially eligible. We included 14 unpublished trials (1308 patients) and 14 publications/preprints (9011 patients). Results for hydroxychloroquine are dominated by RECOVERY and WHO SOLIDARITY, two highly pragmatic trials, which employed relatively high doses and included 4716 and 1853 patients, respectively (67% of the total sample size). The combined OR on all-cause mortality for hydroxychloroquine is 1.11 (95% CI: 1.02, 1.20; I² = 0%; 26 trials; 10,012 patients) and for chloroquine 1.77 (95%CI: 0.15, 21.13, I² = 0%; 4 trials; 307 patients). We identified no subgroup effects. We found that treatment with hydroxychloroquine is associated with increased mortality in COVID-19 patients, and there is no benefit of chloroquine. Findings have unclear generalizability to outpatients, children, pregnant women, and people with comorbidities.

Original languageEnglish
JournalNature Communications
Volume12
Issue number1
Pages (from-to)2349
DOIs
Publication statusPublished - 15 Apr 2021

ID: 65016480