E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051905 |
E.1.2 | Term | Coronavirus infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10070255 |
E.1.2 | Term | Coronavirus test positive |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
-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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
28 days after randomisation |
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E.5.2 | 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. |
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E.5.2.1 | 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) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of trial will be when all samples taken have been analysed and all the data has been entered into the clinical database and all queries have been resolved. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 31 |