Last updated: May 4, 2021
Sponsor: University of Oxford
Overall Status: Completed
Phase
3
Condition
Covid-19
Treatment
N/AClinical Study ID
NCT04381962
ATOMIC2
20/HRA/2105
282892
2020-001740-26
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 attendingclinical team)
- No medical history that might, in the opinion of the attending clinician, put thepatient at significant risk if he/she were to participate in the trial
- Able to understand written English (for the information and consent process) and beable to give informed consent
Exclusion
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 orsucrose-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'stroponin 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 orunstable severe cardiac insufficiency
- Currently on hydroxychloroquine or chloroquine
Study Design
Total Participants: 298
Study Start date:
June 03, 2020
Estimated Completion Date:
April 20, 2021
Study Description
Connect with a study center
Horton General Hospital
Banbury, Oxfordshire OX3 9DU
United KingdomSite Not Available
John Radcliffe Hospital
Oxford, Oxfordshire OX3 9DU
United KingdomSite Not Available
Ninewells Hospital
Dundee, Scotland DD2 1SG
United KingdomSite Not Available
Birmingham City Hospital
Birmingham, B18 7QH
United KingdomSite Not Available
Sandwell General Hospital
West Bromwich, B71 4HJ
United KingdomSite Not Available
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