Hydroxychloroquine for treatment of non-hospitalized adults with COVID-19: A meta-analysis of individual participant data of randomized trials

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  • Mitjà, Oriol
    • Other Affiliation: Fight AIDS and Infectious Diseases Foundation
  • Reis, Gilmar
    • Other Affiliation: Pontifícia Universidade Católica de Minas Gerais
  • Boulware, David R.
    • Other Affiliation: University of Minnesota
  • Spivak, Adam M.
    • Other Affiliation: University of Utah
  • Sarwar, Ammar
    • Other Affiliation: Harvard Medical School
  • Johnston, Christine
    • Other Affiliation: University of Washington
  • Webb, Brandon
    • Other Affiliation: University of Utah
  • Hill, Michael D.
    • Other Affiliation: University of Calgary
  • Smith, Davey
    • Other Affiliation: UC San Diego School of Medicine
  • Kremsner, Peter
    • Other Affiliation: University Hospital of Tübingen
  • Curran, Marla
    • Other Affiliation: Bill & Melinda Gates Medical Research Institute
  • Carter, David
    • Other Affiliation: MMS Holdings
  • Alexander, Jim
    • Other Affiliation: Bill & Melinda Gates Medical Research Institute
  • Corbacho, Marc
    • Other Affiliation: Fight AIDS and Infectious Diseases Foundation
  • Lee, Todd C.
    • Other Affiliation: University of Minnesota
  • Hullsiek, Katherine Huppler
    • Other Affiliation: University of Minnesota
  • McDonald, Emily G.
    • Other Affiliation: McGill University Health Center
  • Hess, Rachel
    • Other Affiliation: University of Utah
  • Hughes, Michael
    • Other Affiliation: Harvard Medical School
  • Baeten, Jared M.
    • Other Affiliation: University of Washington
  • Schwartz, Ilan
    • Other Affiliation: University of Alberta
  • Metz, Luanne
    • Other Affiliation: University of Calgary
  • Richer, Lawrence
    • Other Affiliation: University of Alberta
  • Chew, Kara W.
    • Other Affiliation: University of California, Los Angeles
  • Daar, Eric
    • Other Affiliation: Harbor-UCLA Medical Center
  • Wohl, David
    • Affiliation: School of Medicine
  • Dunne, Michael
    • Other Affiliation: Bill & Melinda Gates Medical Research Institute
Abstract
  • Hydroxychloroquine (HCQ) was initially promoted as an oral therapy for early treatment of coronavirus disease 2019 (COVID-19). Conventional meta-analyses cannot fully address the heterogeneity of different designs and outcomes of randomized controlled trials (RCTs) assessing the efficacy of HCQ in outpatients with mild COVID-19. We conducted a pooled analysis of individual participant data from RCTs that evaluated the effect of HCQ on hospitalization and viral load reduction in outpatients with confirmed COVID-19. We evaluated the overall treatment group effect by log-likelihood ratio test (−2LL) from a generalized linear mixed model to accommodate correlated longitudinal binary data. The analysis included data from 11 RCTs. The outcome of virological effect, assessed in 1560 participants (N = 795 HCQ, N = 765 control), did not differ significantly between the two treatment groups (−2LL = 7.66; p = 0.18) when adjusting for cohort, duration of symptoms, and comorbidities. The decline in polymerase chain reaction positive tests from day 1 to 7 was 42.0 and 41.6 percentage points in the HCQ and control groups, respectively. Among the 2037 participants evaluable for hospitalization (N = 1058 HCQ, N = 979 control), we found no significant differences in hospitalization rate between participants receiving HCQ and controls (odds ratio 0.995; 95% confidence interval 0.614–1.610; −2LL = 0.0; p = 0.98) when adjusting for cohort, duration of symptoms, and comorbidities. This individual participant data meta-analysis of 11 HCQ trials that evaluated severe acute respiratory syndrome-coronavirus 2 viral clearance and COVID-19 hospitalization did not show a clinical benefit of HCQ. Our meta-analysis provides evidence to support the interruption in the use of HCQ in mild COVID-19 outpatients to reduce progression to severe disease.
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  • Article
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  • Attribution-NonCommercial 4.0 International
Journal title
  • Clinical and Translational Science
Language
  • English
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  • Publisher
ISSN
  • 1752-8062
Publisher
  • Wiley Blackwell

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