Horby, P., Mafham, M., Linsell, L., Bell, J. L., Staplin, N., Emberson, J., Wiselka, M., Ustianowski, A., Elmahi, E., Prudon, B., Whitehouse, T., Felton, T., Williams, J., Faccenda, J., Underwood, J. ORCID: https://orcid.org/0000-0001-6963-2821, Baillie, J. K., Chappell, L. C., Faust, S. N., Jaki, T., Jeffery, K., Lim, W. S., Montgomery, A., Rowan, K., Tarning, J., Watson, J. A., White, N. J., Juszczak, E., Haynes, R., Landray, M. J., The RECOVERY Collaborative Group and Adams, R. ORCID: https://orcid.org/0000-0003-3915-7243 2020. Effect of hydroxychloroquine in hospitalized patients with Covid-19. New England Journal of Medicine 383 (21) , pp. 2030-2040. 10.1056/NEJMoa2022926 |
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Abstract
BackgroundHydroxychloroquine and chloroquine have been proposed as treatments for coronavirus disease 2019 (Covid-19) on the basis of in vitro activity and data from uncontrolled studies and small, randomized trials.MethodsIn this randomized, controlled, open-label platform trial comparing a range of possible treatments with usual care in patients hospitalized with Covid-19, we randomly assigned 1561 patients to receive hydroxychloroquine and 3155 to receive usual care. The primary outcome was 28-day mortality.ResultsThe enrollment of patients in the hydroxychloroquine group was closed on June 5, 2020, after an interim analysis determined that there was a lack of efficacy. Death within 28 days occurred in 421 patients (27.0%) in the hydroxychloroquine group and in 790 (25.0%) in the usual-care group (rate ratio, 1.09; 95% confidence interval [CI], 0.97 to 1.23; P=0.15). Consistent results were seen in all prespecified subgroups of patients. The results suggest that patients in the hydroxychloroquine group were less likely to be discharged from the hospital alive within 28 days than those in the usual-care group (59.6% vs. 62.9%; rate ratio, 0.90; 95% CI, 0.83 to 0.98). Among the patients who were not undergoing mechanical ventilation at baseline, those in the hydroxychloroquine group had a higher frequency of invasive mechanical ventilation or death (30.7% vs. 26.9%; risk ratio, 1.14; 95% CI, 1.03 to 1.27). There was a small numerical excess of cardiac deaths (0.4 percentage points) but no difference in the incidence of new major cardiac arrhythmia among the patients who received hydroxychloroquine.ConclusionsAmong patients hospitalized with Covid-19, those who received hydroxychloroquine did not have a lower incidence of death at 28 days than those who received usual care. (Funded by UK Research and Innovation and National Institute for Health Research and others; RECOVERY ISRCTN number, ISRCTN50189673. opens in new tab; ClinicalTrials.gov number, NCT04381936. opens in new tab.)
Item Type: | Article |
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Date Type: | Publication |
Status: | Published |
Schools: | Medicine |
Additional Information: | R. Adams is a member of the The RECOVERY Collaborative Group |
Publisher: | Massachusetts Medical Society |
ISSN: | 0028-4793 |
Date of First Compliant Deposit: | 10 March 2021 |
Date of Acceptance: | 23 October 2020 |
Last Modified: | 06 May 2023 23:51 |
URI: | https://orca.cardiff.ac.uk/id/eprint/139440 |
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