Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19: a randomised double-blinded placebo-controlled trial
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Background Combining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having in vitro antiviral properties. This may improve outcomes in patients hospitalised for coronavirus disease 2019 (COVID-19). Methods Placebo-controlled double-blind randomised multicentre trial. Patients aged ≽18 years, admitted to hospital for ≼48 h (not intensive care) with a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcription PCR test were recruited. The intervention was 500 mg daily azithromycin for 3 days followed by 250 mg daily azithromycin for 12 days combined with 200 mg twice-daily hydroxychloroquine for all 15 days. The control group received placebo/placebo. The primary outcome was days alive and discharged from hospital within 14 days (DAOH14). Results After randomisation of 117 patients, at the first planned interim analysis, the data and safety monitoring board recommended stopping enrolment due to futility, based on pre-specified criteria. Consequently, the trial was terminated on 1 February 2021. 61 patients received the combined intervention and 56 patients received placebo. In the intervention group, patients had a median (interquartile range) 9.0 (3–11) DAOH14 versus 9.0 (7–10) DAOH14 in the placebo group (p=0.90). The primary safety outcome, death from all causes on day 30, occurred for one patient in the intervention group versus two patients receiving placebo (p=0.52), and readmittance or death within 30 days occurred for nine patients in the intervention group versus six patients receiving placebo (p=0.57). Conclusions The combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.
|Tidsskrift||European Respiratory Journal|
|Status||Udgivet - 2022|
Support statement: The study was funded by The Novo Nordisk Foundation (grant number: NNF20SA0062834). The research salary of P. Sivapalan was sponsored by Herlev and Gentofte Hospital, University Hospital of Copenhagen. The funders had no role in the design and conduct of the study, in the collection, management, analysis, and interpretation of the data, or in the preparation, review, or approval of the manuscript or the decision to submit the manuscript for publication. This trial was not supported in any form by the pharmaceutical industry. P. Sivapalan and J-U.S. Jensen had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analyses. Funding information for this article has been deposited with the Crossref Funder Registry.
Conflict of interest: P. Sivapalan reports fees from Boehringer Ingelheim, outside the submitted work. C.S. Ulrik reports fees from Boehringer Ingelheim, AZ, GSK, TEVA, Novartis, ALK-Abello, Mundipharma, Sanofi Genzyme, Orion Pharma and Actelion, outside the submitted work. K.E.J. Håkansson reports personal fees from AstraZeneca, Chiesi and TEVA, outside the submitted work. T. Biering-Sørensen has received research grants from GE Healthcare and Sanofi Pasteur, as well as personal fees from Sanofi Pasteur, Novartis and Amgen, outside the submitted work. None of the other authors have any conflicts of interest.
Copyright © The authors 2022.