E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteer (Prophylaxis for COVID-19) |
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E.1.1.1 | Medical condition in easily understood language |
Investigation of preventive medical treatment for the disease caused by Coronavirus-19 |
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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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10049087 |
E.1.2 | Term | Antiviral prophylaxis |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051905 |
E.1.2 | Term | Coronavirus 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 |
To investigate whether prophylactic treatment with daily hydroxychloroquine, vitamin D, and zinc supplementation reduces the risk of COVID-19, the severity of the disease, the hospitalization rate, and death in nursing home residents. |
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E.2.2 | Secondary objectives of the trial |
To assess the effect of prophylactic treatment with hydroxychloroquine, vitamin D, and zinc compared with no treatment in nursing home residents not previously infected with SARS-CoV-2 on: - SARS-CoV-2 positive real-time PCR from nasopharyngeal samples - Influenza positive real-time PCR from nasopharyngeal samples - Hospitalization (related) - Hospitalization (any) - Need for intensive care respiratory support if hospitalized - Length of disease course - Contact to general practitioner (any) - Side effects (stomach pain, nausea, reduced appetite, diarrhea, vomiting, headache, skin rash, decreased hepatic functioning, or prolonged cardiac QT interval) - Death (30 days, 90 days)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Nursing home residents - ≥ 65 years of age - Able to give informed consent or consent by proxy
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E.4 | Principal exclusion criteria |
- Prior SARS-CoV-2 positive rtPCR test - Terminal illness - Current prescription of hydroxychloroquine or chloroquine - Allergy to hydroxychloroquine or chloroquine - Known to suffer from either of the following: Cardiomyopathy; G6PD deficiency; Retinopathy; Severe hearing -deficits; QT prolongation; Child Pugh Score = C; psoriasis, myasthenia gravis; dysregulated diabetes, eGFR < 20 ml/min - Deemed unable to swallow oral tablets - Intake of the following medication due to potential QT prolongation o Macrolides, quinolones, voriconazole, psychotropics with high risk of QT prolongation, amiodarone, or methadone Intake of the following medication due to potential interaction o Digoxin
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E.5 End points |
E.5.1 | Primary end point(s) |
SARS-CoV-2 positive rtPCR from nasopharyngeal samples during 2 months prophylactic treatment with hydroxychloroquine, vitamin D, and zinc supplement or no prophylactic treatment |
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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) |
1. Clinically evident COVID-19 2. Influenza positive real-time PCR from nasopharyngeal samples 3. Hospitalization (related) 4. Hospitalization (any) 5. Need for intensive care respiratory support if hospitalized 6. Length of disease course 7. Contact to general practitioner (any) 8. Death 9. Adherence to intervention 10. SARS-CoV-2 positive rtPCR in participants with severe cognitive dysfunction
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1: 0, 30, 60, and 90 days 2: 0, 30, 60, and 90 days 3: 30, 60, and 90 days 4: 30, 60, and 90 days 5: 30, 60, and 90 days 6: 30, 60, and 90 days 7: 30, 60, and 90 days 8: 30, and 90 days 9: 60 days 10: 0, 30, 60 and 90 days
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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 | 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) | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
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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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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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |