Status:
COMPLETED
A Multicentre Open-label Two-arm Randomised Superiority Clinical Trial of Azithromycin Versus Usual Care In Ambulatory COVID19 (ATOMIC2)
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Pfizer
Conditions:
COVID-19
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief 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 clinica...
Detailed Description
Hypothesis: Use of Azithromycin 500 mg once daily for 14 days is effective in preventing and/or reducing the severity of lower respiratory illness of COVID-19 disease at 28 days. Study design: Multi ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2021
Estimated Enrollment :
298 Patients enrolled
Trial Details
Trial ID
NCT04381962
Start Date
June 3 2020
End Date
April 20 2021
Last Update
May 6 2021
Active Locations (5)
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1
Horton General Hospital
Banbury, Oxfordshire, United Kingdom, OX3 9DU
2
John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom, OX3 9DU
3
Ninewells Hospital
Dundee, Scotland, United Kingdom, DD2 1SG
4
Birmingham City Hospital
Birmingham, United Kingdom, B18 7QH