biostudies-literaturePRINCIPLE Trial Collaborative GroupMedical Research CouncilNational Institute for Health Research (NIHR)Wellcome Trust1063-1074https://www.ebi.ac.uk/biostudies/studies/S-EPMC7972318biostudies-literatureUnknown397(10279)<h4>Background</h4>Azithromycin, an antibiotic with potential antiviral and anti-inflammatory properties, has been used to treat COVID-19, but evidence from community randomised trials is lacking. We aimed to assess the effectiveness of azithromycin to treat suspected COVID-19 among people in the community who had an increased risk of complications.<h4>Methods</h4>In this UK-based, primary care, open-label, multi-arm, adaptive platform randomised trial of interventions against COVID-19 in people at increased risk of an adverse clinical course (PRINCIPLE), we randomly assigned people aged 65 years and older, or 50 years and older with at least one comorbidity, who had been unwell for 14 days or less with suspected COVID-19, to usual care plus azithromycin 500 mg daily for three days, usual Lancet (London, England)Azithromycin for community treatment of suspected COVID-19 in people at increased risk of an adverse clinical course in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial.PMC7972318NIHR300105CV220-074 - PRINCIPLE extension216421/Z/19/ZMC_PC_19079NF-SI-0515-10056203921/Z/16/ZHayward GVan Hecke Ode Lusignan SButler CCHarris VGbinigie OSaville BRThomas NPSaunders COgburn EBerry NPRINCIPLE Trial Collaborative GroupEvans PHPatel MGHobbs FRDorward JYu LMDetry MFitzgerald MfalseAzithromycin for community treatment of suspected COVID-19 in people at increased risk of an adverse clinical course in the UK (PRINCIPLE): a randomised, controlled, open-label, adaptive platform trial.<h4>Background</h4>Azithromycin, an antibiotic with potential antiviral and anti-inflammatory properties, has been used to treat COVID-19, but evidence from community randomised trials is lacking. We aimed to assess the effectiveness of azithromycin to treat suspected COVID-19 among people in the community who had an increased risk of complications.<h4>Methods</h4>In this UK-based, primary care, open-label, multi-arm, adaptive platform randomised trial of interventions against COVID-19 in people at increased risk of an adverse clinical course (PRINCIPLE), we randomly assigned people aged 65 years and older, or 50 years and older with at least one comorbidity, who had been unwell for 14 days or less with suspected COVID-19, to usual care plus azithromycin 500 mg daily for three days, usual 2021-01-01T00:00:00Z2021 Mar2026-06-11T06:20:05.694Z2025-02-19T00:32:49.037ZS-EPMC79723183367659710.1016/S0140-6736(21)00461-X