E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
COVID-19, acute respiratory illness |
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E.1.1.1 | Medical condition in easily understood language |
Corona virus disease, acute respiratory illness |
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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 | LLT |
E.1.2 | Classification code | 10053983 |
E.1.2 | Term | Corona virus infection |
E.1.2 | System Organ Class | 100000004862 |
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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 |
The primary objective is to determine if chloroquine or hydroxychloroquine prophylaxis prevents symptomatic COVID-19 infection in healthcare workers
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E.2.2 | Secondary objectives of the trial |
The secondary objectives include: - Reduction in the clinical severity or duration of COVID-19 infections. - The prevention of asymptomatic COVID-19. - The prevention of symptomatic all-cause acute respiratory infections (ARI). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Participant is willing and able to give informed consent for participation in the study 2. Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals 3. Adults (exact age is dependent on countries) less than 70 years old at the time of consent). See Appendix F for UK specific information 4. Not previously diagnosed with COVID-19 5. Not currently symptomatic with an ARI 6. Participant works in a facility where there are cases of either proven or suspected COVID-19 7. Possesses an internet-enabled smartphone (Android or iOS)
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E.4 | Principal exclusion criteria |
1. Hypersensitivity reaction to chloroquine, hydroxychloroquine or 4-aminoquinolines 2. Contraindication to taking chloroquine as prophylaxis e.g. known epileptic, known creatinine clearance < 10 ml/min 3. Already taking chloroquine, hydroxychloroquine or 4-aminoquinolines 4. Taking a concomitant medication described in section 8.5 5. Known retinal disease 6. Inability to be followed up for the trial period 7. Known prolonged QT syndrome (however ECG is not required at baseline) 8. Prior diagnosis of porphyria 9. Known pregnancy or women who are actively trying to become pregnant
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure is: The number of symptomatic COVID-19 infections will be compared between participants randomised to chloroquine or hydroxychloroquine, and placebo groups. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
The secondary outcome measures are : - The symptoms severity and duration of COVID-19 illness, in those who become infected during the study will be compared between the two groups using a respiratory severity score. - The number of asymptomatic cases of COVID-19 will be determined by comparing serology in all participants at time of enrolment and at the end of follow up. - The number and severity of symptomatic acute respiratory illnesses will be compared in participants randomised to chloroquine or hydroxychloroquine, and placebo groups.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.3 | Therapy | No |
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) | Yes |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
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 | 25 |
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 | 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 the study will be the date of the last visit of the last participant, the last dose of the study drug or up to 60 days after the diagnosis of COVID-19/ ARI of the last participant enrolled in the study, whichever comes last.
In the UK, the end of the study will be after the completion of the follow-up via medical records and organisations such as NHS digital - this will be 15 years after the last participant is randomised in the UK.
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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 | 15 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 15 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 5 |