A Multicentre Open-label Two-arm Randomised Superiority Clinical Trial of Azithromycin Versus Usual Care In Ambulatory COVID19 (ATOMIC2) (ATOMIC2)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring SARS-CoV-2, Coronavirus, COVID-19, Azithromycin, Respiratory failure, Mortality, Trial
Eligibility 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
Sites / Locations
- Horton General Hospital
- John Radcliffe Hospital
- Ninewells Hospital
- Birmingham City Hospital
- Sandwell General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Azithromycin
Usual standard care
Azithromycin 2x250mg capsules to be taken orally once daily for 14 days. The first dose will be within 4 hours of randomisation. This is in addition to standard care as per local hospital advice for those patients with suspected COVID who are not admitted: i.e. symptomatic relief with rest, as-required paracetamol (where appropriate) and advice to seek further medical attention if significant worsening of breathlessness.
Standard care as per local hospital advice for those patients with suspected COVID who are not admitted: i.e. symptomatic relief with rest, as-required paracetamol (where appropriate) and advice to seek further medical attention if significant worsening of breathlessness.