@article {Sivapalan2100752, author = {Pradeesh Sivapalan and Charlotte Suppli Ulrik and Therese Sophie Lapperre and Rasmus Dahlin Bojesen and Josefin Ekl{\"o}f and Andrea Browatzki and Jon Torgny Wilcke and Vibeke Gottlieb and Kjell Erik Julius H{\r a}kansson and Casper Tidemandsen and Oliver Tupper and Howraman Meteran and Christina Bergs{\o}e and Eva Br{\o}ndum and Uffe Bodtger and Daniel Bech Rasmussen and Sidse Graff Jensen and Lars Pedersen and Alexander Jordan and Helene Priem{\'e} and Christian S{\o}borg and Ida E. Steffensen and Dorthe H{\o}gsberg and Tobias Wirenfeldt Klausen and Martin Steen Frydland and Peter Lange and Asger Sverrild and Muhzda Ghanizada and Filip Krag Knop and Tor Biering-S{\o}rensen and Jens D. Lundgren and Jens-Ulrik St{\ae}hr Jensen,}, editor = {,}, title = {Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19{\textendash}a randomised double-blinded placebo-controlled trial}, elocation-id = {2100752}, year = {2021}, doi = {10.1183/13993003.00752-2021}, publisher = {European Respiratory Society}, abstract = {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 COVID-19.Methods 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).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 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{\textendash}11) versus. 9.0 DAOH14 (IQR, 7{\textendash}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).Conclusions The combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.There are no beneficial or harmful effects from the combined intervention of hydroxychloroquine and azithromycin for hospitalised patients with confirmed coronavirus disease 2019 (COVID-19).}, issn = {0903-1936}, URL = {https://erj.ersjournals.com/content/early/2021/05/28/13993003.00752-2021}, eprint = {https://erj.ersjournals.com/content/early/2021/05/28/13993003.00752-2021.full.pdf}, journal = {European Respiratory Journal} }