COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001740-26/GB

University of Oxford - OCTRU

octrutrialshub@ndorms.ox.ac.uk

2020-04-24

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Male or Female, aged at least 18 years Assessed as appropriate for initial ambulatory (outpatient) management A clinical diagnosis of highly-probable COVID-19 infection 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, Clinical Trials and Research Governance

18

100

United Kingdom

Mild disease at enrollment

1: Mild disease at enrollment

800

To compare the effect of Azithromycin in participants with a clinical diagnosis of COVID-19 in reducing the proportion with either death or hospital admission with respiratory failure requiring Non-Invasive Mechanical Ventilation (NIV) or Invasive Mechanical Ventilation (IMV) over the 28 days from randomisation.

Declared number of arm (2.0) differs from found arms (1.0)

Phase 2

[{"arm_notes": "New Type treatment : Azithromycin dihydrate", "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"}]