COVID-19 MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: PT Classification code 10070255 Term: Coronavirus test positive System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Zithromax
Product Name: Zithromax
Pharmaceutical Form: Capsule
INN or Proposed INN: Azithromycin dihydrate
CAS Number: 117772-70-0
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
University of Oxford, Clinical Trials and Research Governance
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Can a course of antibiotics reduce the number of people with COVID-19 symptoms who go to hospital but who doctors decide do not need to be admitted from getting worse? (There is where worse is considered being admitted to hospital or dying). Another more scientific way of describing this is: Does giving patients who have a clinical diagnosis of COVID-19 who go to hospital with their symptoms, but who doctors decide to not need to be admitted and and are sent home, does giving these patients 14 days of an antibiotic called Azithromycin result in reducing the number of patients who then either die or get admitted to hospital with respiratory failure requiring help with their breathing either by Non-Invasive Mechanical Ventilation (NIV) or Invasive Mechanical Ventilation (IMV) in the period of 28 days from randomisation. ;Secondary Objective: -Are there differences in those that die in each group in the trial -Are there differences in those that die or are admitted to hospital for help with their breathing (when those that take part are split into those that a test called a PCR confirms that the patient does indeed have COVID-19 or not - Are there differences in those that progress to having pneumonia in each group - Are there differences in those that progress to have severe pneumonia in each group - Are there differences in the peak severity of illness scores in each group - Are these differences in the number of severe adverse events in each group;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: 28 days after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To compare the effect of Azithromycin in participants with a PCR-confirmed diagnosis of COVID-19 in reducing the proportion with either death or hospital admission with respiratory failure requiring invasive or non-invasive mechanical ventilation over 28 days from randomisation. To compare differences in all-cause mortality. To compare differences in pneumonia. To compare differences in proportion progressing to severe pneumonia. To compare differences in peak severity of illness.;Timepoint(s) of evaluation of this end point: Up to 28 days after randomisation (Hospital stay may be after 28 days if the incidence is not contained with 28 days of randomisation) | — |
Countries
United Kingdom
Contacts
Public ContactOCTRU
University of Oxford
Outcome results
None listed