A Multicentre Open-label Two-arm Randomised Superiority Clinical Trial of Azithromycin Versus Usual Care In Ambulatory COVID19 (ATOMIC2)

• Status: Completed
• Trial end date: 2021-04-20
• Target enrollment: 0
• Participant gender: All

Summary

A multi-centre open-label two-arm randomised superiority clinical trial of two weeks of oral Azithromycin 500mg once daily versus usual care in adult patients presenting to secondary care with clinically-diagnosed COVID-19 but assessed as appropriate for initial ambulant (outpatient) management, in preventing progression to respiratory failure or death.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborator: Pfizer
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

• Male or Female, aged at least 18 years

• Assessed by the attending clinical team as appropriate for initial ambulatory (outpatient) management

• A clinical diagnosis of highly-probable COVID-19 infection (diagnosis by the attending clinical team)

• No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial

• Able to understand written English (for the information and consent process) and be able to give informed consent

Exclusion Criteria:

• Known hypersensitivity to any Macrolide including Azithromycin, Ketolide antibiotic, or the excipients including an allergy to soya or peanuts.

• Known fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase-insufficiency

• Currently on a Macrolide antibiotic (Clarithromycin, Azithromycin, Erythromycin, Telithromycin, Spiramycin)

• On any SSRI (Selective Serotonin Reuptake Inhibitor)

• Elevated cardiac troponin at initial assessment suggestive of significant myocarditis (if clinically the clinical team have felt it appropriate to check the patient's troponin levels)

• Evidence of QTc prolongation: QTc>480ms

• Significant electrolyte disturbance (e.g. hypokalaemia K+<3.5 mmol/L)

• Clinically relevant bradycardia (P<50 bpm), non-sustained ventricular tachycardia or unstable severe cardiac insufficiency

• Currently on hydroxychloroquine or chloroquine