Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19-a randomised double-blinded placebo-controlled trial.

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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 COVID-19.Placebo-controlled double-blind randomised multicentre trial. Patients ≥18 years, admitted to hospital for≤48 h (not intensive care) with a positive SARS-CoV-2 RT-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).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 February 1, 2021. A total of 61 patients received the combined intervention and 56 patients received placebo. In the intervention group, patients had a median of 9.0 DAOH14 (IQR, 3-11) versus. 9.0 DAOH14 (IQR, 7-10) in the placebo group (p=0.90). The primary safety outcome, death from all causes on day 30, occurred for 1 patient in the intervention group versus. 2 patients receiving placebo (p=0.52), and readmittance or death within 30 days occurred for 9 patients in the intervention group versus. 6 patients receiving placebo (p=0.57).The combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.

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Authors: Pradeesh Sivapalan, Charlotte Suppli Ulrik, Therese Sophie Lapperre, Rasmus Dahlin Bojesen, Josefin Eklöf, Andrea Browatzki, Jon Torgny Wilcke, Vibeke Gottlieb, Kjell Erik Julius Håkansson, Casper Tidemandsen, Oliver Tupper, Howraman Meteran, Christina Bergsøe, Eva Brøndum, Uffe Bodtger, Daniel Bech Rasmussen, Sidse Graff Jensen, Lars Pedersen, Alexander Jordan, Helene Priemé, Christian Søborg, Ida E Steffensen, Dorthe Høgsberg, Tobias Wirenfeldt Klausen, Martin Steen Frydland, Peter Lange, Asger Sverrild, Muhzda Ghanizada, Filip Krag Knop, Tor Biering-Sørensen, Jens D Lundgren, Jens-Ulrik Stæhr Jensen, ProPAC-COVID study group