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 |
Norwegian Coronavirus disease 2019 |
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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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037373 |
E.1.2 | Term | Pulmonary disorder |
E.1.2 | System Organ Class | 100000004855 |
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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 assess whether early treatment with chloroquine in patients with established COVID-19 will significantly reduce replication rate of SARS-CoV-2. |
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E.2.2 | Secondary objectives of the trial |
• Assess the impact of early treatment with chloroquine in patients with established COVID-19 on rate of decline in SARS-CoV-2 viral load in nasopharyngeal samples as assessed by RT-PCR from baseline to 96 hours
• Assess the impact of early treatment with chloroquine in patients with established COVID-19 on changes in NEWS score
• Assess the impact of early treatment with chloroquine in patients with established COVID-19 on admission rate to ICU
• Assess the impact of early treatment with chloroquine in patients with established COVID-19 on in hospital mortality
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Hospitalised
2. Adults 18 year or older
3. Moderately severe disease (NEWS score ≤ 6)
4. SARS-CoV-2 positive nasopharyngeal swab
5. Signed informed consent must be obtained and documented according to ICH GCP, and national/local regulations.
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E.4 | Principal exclusion criteria |
1. Requiring ICU admission at screening
2. History of psoriasis
3. Tinnitus, reduced hearing
4. Visual impairment
5. Known adverse reaction to hydroxychloroquine sulphate
6. Pregnancy
7. Prolonged QT interval (>450 ms)
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E.5 End points |
E.5.1 | Primary end point(s) |
Rate of decline in SARS-CoV-2 viral load in nasopharyngeal samples as assessed by RT-PCR in samples collected at baseline, 48 and 96 hours after randomization |
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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) |
• Change in NEWS score at 96 hours after randomization
• Admission to ICU
• In-hospital mortality
• Duration of hospital admission
• Mortality at 30 and 90 days
• Clinical status will also be assessed by percentage of subjects reporting each severity rating on a 6-point ordinal scale 96 hours after randomization:
1. Death
2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation
3. Hospitalized, on non-invasive ventilation or high flow oxygen devices
4. Hospitalized, requiring supplemental oxygen
5. Hospitalized, not requiring supplemental oxygen
6. Not hospitalized
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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 | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
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) | 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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 9 |