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Azithromycin versus standard care in patients with mild-to-moderate COVID-19 (ATOMIC2): an open-label, randomised trial.
Hinks, Timothy S C; Cureton, Lucy; Knight, Ruth; Wang, Ariel; Cane, Jennifer L; Barber, Vicki S; Black, Joanna; Dutton, Susan J; Melhorn, James; Jabeen, Maisha; Moss, Phil; Garlapati, Rajendar; Baron, Tanya; Johnson, Graham; Cantle, Fleur; Clarke, David; Elkhodair, Samer; Underwood, Jonathan; Lasserson, Daniel; Pavord, Ian D; Morgan, Sophie; Richards, Duncan.
  • Hinks TSC; Respiratory Medicine Unit and National Institute for Health Research Oxford Biomedical Research Centre, Nuffield Department of Medicine Experimental Medicine, University of Oxford, Oxford, UK. Electronic address: timothy.hinks@ndm.ox.ac.uk.
  • Cureton L; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.
  • Knight R; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.
  • Wang A; Respiratory Medicine Unit and National Institute for Health Research Oxford Biomedical Research Centre, Nuffield Department of Medicine Experimental Medicine, University of Oxford, Oxford, UK.
  • Cane JL; Respiratory Medicine Unit and National Institute for Health Research Oxford Biomedical Research Centre, Nuffield Department of Medicine Experimental Medicine, University of Oxford, Oxford, UK.
  • Barber VS; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.
  • Black J; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.
  • Dutton SJ; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.
  • Melhorn J; University Hospital Llandough, Cardiff, UK.
  • Jabeen M; Respiratory Medicine Unit and National Institute for Health Research Oxford Biomedical Research Centre, Nuffield Department of Medicine Experimental Medicine, University of Oxford, Oxford, UK.
  • Moss P; Emergency Department Clinical Research Unit, St George's Hospital, London, UK.
  • Garlapati R; Accident and Emergency, East Lancashire NHS Hospitals, Blackburn, UK.
  • Baron T; Emergency Department, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
  • Johnson G; University Hospitals of Derby and Burton, Royal Derby Hospital, Derby, UK; University of Nottingham, Lenton, Nottingham UK.
  • Cantle F; Department of Emergency Medicine, King's College Hospital, London, UK.
  • Clarke D; Royal Berkshire Hospital, Reading, UK.
  • Elkhodair S; Emergency Department, University College London Hospital, London UK.
  • Underwood J; Department of Infectious Diseases, Cardiff and Vale University Health Board, Cardiff, UK; Division of Infection and Immunity, Cardiff University, Cardiff, UK.
  • Lasserson D; Department of Geratology, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, UK; Department of Acute Medicine, Sandwell and West Birmingham Hospitals NHS Trust, City Hospital, Birmingham, UK; Warwick Medical School, University of Warwick, Coventry, UK.
  • Pavord ID; Respiratory Medicine Unit and National Institute for Health Research Oxford Biomedical Research Centre, Nuffield Department of Medicine Experimental Medicine, University of Oxford, Oxford, UK.
  • Morgan S; Respiratory Medicine Unit and National Institute for Health Research Oxford Biomedical Research Centre, Nuffield Department of Medicine Experimental Medicine, University of Oxford, Oxford, UK.
  • Richards D; Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.
Lancet Respir Med ; 9(10): 1130-1140, 2021 10.
Article in English | MEDLINE | ID: covidwho-1305334
ABSTRACT

BACKGROUND:

The antibacterial, anti-inflammatory, and antiviral properties of azithromycin suggest therapeutic potential against COVID-19. Randomised data in mild-to-moderate disease are not available. We assessed whether azithromycin is effective in reducing hospital admission in patients with mild-to-moderate COVID-19.

METHODS:

This prospective, open-label, randomised superiority trial was done at 19 hospitals in the UK. We enrolled adults aged at least 18 years presenting to hospitals with clinically diagnosed, highly probable or confirmed COVID-19 infection, with fewer than 14 days of symptoms, who were considered suitable for initial ambulatory management. Patients were randomly assigned (11) to azithromycin (500 mg once daily orally for 14 days) plus standard care or to standard care alone. The primary outcome was death or hospital admission from any cause over the 28 days from randomisation. The primary and safety outcomes were assessed according to the intention-to-treat principle. This trial is registered at ClinicalTrials.gov (NCT04381962) and recruitment is closed.

FINDINGS:

298 participants were enrolled from June 3, 2020, to Jan 29, 2021. Three participants withdrew consent and requested removal of all data, and three further participants withdrew consent after randomisation, thus, the primary outcome was assessed in 292 participants (145 in the azithromycin group and 147 in the standard care group). The mean age of the participants was 45·9 years (SD 14·9). 15 (10%) participants in the azithromycin group and 17 (12%) in the standard care group were admitted to hospital or died during the study (adjusted OR 0·91 [95% CI 0·43-1·92], p=0·80). No serious adverse events were reported.

INTERPRETATION:

In patients with mild-to-moderate COVID-19 managed without hospital admission, adding azithromycin to standard care treatment did not reduce the risk of subsequent hospital admission or death. Our findings do not support the use of azithromycin in patients with mild-to-moderate COVID-19.

FUNDING:

National Institute for Health Research Oxford Biomedical Research Centre, University of Oxford and Pfizer.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Patient Admission / Azithromycin / COVID-19 Drug Treatment / Anti-Infective Agents Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: Lancet Respir Med Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Patient Admission / Azithromycin / COVID-19 Drug Treatment / Anti-Infective Agents Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: Lancet Respir Med Year: 2021 Document Type: Article