COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04381962

Paul Little, MD PhD

Lucy Cureton, atomic2@ndorms.ox.ac.uk (PI email not reported)

2020-05-11

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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

- 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

2

University of Oxford

19

None

United Kingdom

Mild disease at enrollment

1: Mild disease at enrollment

298

Proportion progressing to respiratory failure or death (all clinically-diagnosed participants)

None

Phase 3

[{"arm_notes": "", "treatment_id": 165, "treatment_name": "Azithromycin", "treatment_type": "Antibiotics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]