Effect of Hydroxychloroquine in Hospitalized Patients with COVID-19: Preliminary results from a multi-centre, randomized, controlled trial. | medRxiv preprints (not peer reviewed)

Type Journal Article Author Peter Horby Author Marion Mafham Author Louise Linsell Author Jennifer L. Bell Author Natalie Staplin Author Jonathan R. Emberson Author Martin Wiselka Author Andrew Ustianowski Author Einas Elmahi Author Benjamin Prudon Author Anthony Whitehouse Author Timothy Felton Author John Williams Author Jakki Faccenda Author Jonathan Underwood Author J. Kenneth Baillie Author Lucy Chappell Author Saul N. Faust Author Thomas Jaki Author Katie Jeffery Author Wei Shen Lim Author Alan Montgomery Author Kathryn Rowan Author Joel Tarning Author James A. Watson Author Nicholas J. White Author Edmund Juszczak Author Richard Haynes Author Martin J. Landray URL https://www.medrxiv.org/content/10.1101/2020.07.15.20151852v1 Rights © 2020, Posted by Cold Spring Harbor Laboratory. This pre-print is available under a Creative Commons License (Attribution 4.0 International), CC BY 4.0, as described at http://creativecommons.org/licenses/by/4.0/ Pages 2020.07.15.20151852 Publication medRxiv Date 15/07/2020 Extra Publisher: Cold Spring Harbor Laboratory Press DOI 10.1101/2020.07.15.20151852 Library Catalog www.medrxiv.org Language en Abstract Background: Hydroxychloroquine and chloroquine have been proposed as treatments for coronavirus disease 2019 (COVID-19) on the basis of in vitro activity, uncontrolled data, and small randomized studies. Methods: The Randomised Evaluation of COVID-19 therapy (RECOVERY) trial is a randomized, controlled, open-label, platform trial comparing a range of possible treatments with usual care in patients hospitalized with COVID-19. We report the preliminary results for the comparison of hydroxychloroquine vs. usual care alone. The primary outcome was 28-day mortality. Results: 1561 patients randomly allocated to receive hydroxychloroquine were compared with 3155 patients concurrently allocated to usual care. Overall, 418 (26.8%) patients allocated hydroxychloroquine and 788 (25.0%) patients allocated usual care died within 28 days (rate ratio 1.09; 95% confidence interval [CI] 0.96 to 1.23; P=0.18). Consistent results were seen in all pre-specified subgroups of patients. Patients allocated to hydroxychloroquine were less likely to be discharged from hospital alive within 28 days (60.3% vs. 62.8%; rate ratio 0.92; 95% CI 0.85-0.99) and those not on invasive mechanical ventilation at baseline were more likely to reach the composite endpoint of invasive mechanical ventilation or death (29.8% vs. 26.5%; risk ratio 1.12; 95% CI 1.01-1.25). There was no excess of new major cardiac arrhythmia. Conclusions: In patients hospitalized with COVID-19, hydroxychloroquine was not associated with reductions in 28-day mortality but was associated with an increased length of hospital stay and increased risk of progressing to invasive mechanical ventilation or death. Short Title Effect of Hydroxychloroquine in Hospitalized Patients with COVID-19