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 |
corona infectie |
corona infectie |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
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 |
Does addition of azithromycin to standard chloroquine treatment result in a higher clinical cure rate at day 7 than treatment with chloroquine alone in patients with COVID-19.
Cure is considered when 4 criteria are present: (1) O2 sat > 94% with room air (2) 24 hours without fever (≥38°C) (3) Breathing frequency < 24/min
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E.2.2 | Secondary objectives of the trial |
Does addition of azithromycin to standard chloroquine treatment result in a higher viral clearance rate at day 7 confirmed by a negative COVID-19 PCR than treatment with chloroquine alone in patients with COVID-19. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Proven diagnosis of COVID-19 by positive PCR in any specimen < 48 hours prior to randomization. • Age ≥ 18 year • Hospitalized patients with illness of any duration, and SpO2 ≤ 94% on room air
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• Proven diagnosis of COVID-19 by positive PCR in any specimen < 48 hours prior to randomization. • Age ≥ 18 year • Hospitalized patients with illness of any duration, and SpO2 ≤ 94% on room air |
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E.4 | Principal exclusion criteria |
• Severe hypoxemic respiratory failure expected to die < 72 hours after admission • ICU admission < 72 hours • Allergy for chloroquine or azithromycin • Pregnancy • QT-prolongation: pre-existent: QTc males >450ms, QTc females > 470ms at day 1 and at day 2 • Myasthenia gravis • Epilepsy
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• Severe hypoxemic respiratory failure expected to die < 72 hours after admission • ICU admission < 72 hours • Allergy for chloroquine or azithromycin • Pregnancy • QT-prolongation: pre-existent: QTc males >450ms, QTc females > 470ms at day 1 and at day 2 • Myasthenia gravis • Epilepsy |
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E.5 End points |
E.5.1 | Primary end point(s) |
The initial response to treatment will be evaluated during admission. Cure is considered when 3 criteria are present: (1) O2 sat > 94% with room air (2) 24 hours without fever (≥38°C) (3) Breathing frequency < 24/min
The percentage of patients with clinical cure at day 7 will be calculated
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The initial response to treatment will be evaluated during admission. Cure is considered when 3 criteria are present: (1) O2 sat > 94% with room air (2) 24 hours without fever (≥38°C) (3) Breathing frequency < 24/min
The percentage of patients with clinical cure at day 7 will be calculated |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
days of admission to day of discharge primary endpoint will be determined at day 7 |
days of admission to day of discharge primary endpoint will be determined at day 7 |
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E.5.2 | Secondary end point(s) |
• Does addition of azithromycin to standard chloroquine treatment result in a higher viral clearance rate at day 7 confirmed by a negative COVID-19 PCR than treatment with chloroquine alone in patients with COVID-19. • Day of normalisation of lymphocyte count
• Time of clinical cure (days)
• Length of stay
• Number of ICU admissions
• Mortality
• Adverse events
• CRP course
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• Does addition of azithromycin to standard chloroquine treatment result in a higher viral clearance rate at day 7 confirmed by a negative COVID-19 PCR than treatment with chloroquine alone in patients with COVID-19. • Day of normalisation of lymphocyte count
• Time of clinical cure (days)
• Length of stay |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
days of admission to day of discharge secondary endpoint will be determined at day 7 |
days of admission to day of discharge secondary endpoint will be determined at day 7 |
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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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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) | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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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win 60 patients are included |
na inclusie van 60 patiënten |
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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 | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |