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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Rate of hospitalization or death at day 7 after study inclusion |
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E.2.2 | Secondary objectives of the trial |
Duration of hospitalization ● Time to hospitalization ● Reason for hospitalization ● severity of disease at hospitalization All-cause mortality within 30/60 days ● COVID19 related mortality within 30/60 days ● Proportion requiring invasive ventilation ● Proportion admitted to ICU ● Rate of viral clearance defined as SARS-CoV2 specific RNA copy number <100 in throat swabs on day 7 ● Optional rate of viral clearance on d 14, 21 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Written informed consent • Age ≥ 65 years • Mild to moderate symptomatic respiratory tract Infection • Proven SARS-Cov2 infection by throat swab (PCR) • Onset of symptoms within the last 3 days before randomization • Must be able to adhere to the study visit schedule and other protocol requirements in the investigator’s opinion.
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E.4 | Principal exclusion criteria |
• Hospitalization at study inclusion • Weight <50 kg • Acute myocardial infarction • Use of concomitant medications that prolong the QT/QTc interval. • QTc >450ms • Bilirubin ≥ 1,5 x UNL, • AST/ALT ≥ 3 x ULN • Albumine ≤ 2.8 g/dl • Hemoglobin ≤ 9 g/dl • Leucocytes ≤ 2000/µl • Neutrophiles ≤ 1000/µl • Thrombocytes ≤ 100.000/µl • Troponin elevation • BNP > 500 pg/ml • Creatine kinase > 5 x ULN • Creatinine >1,5 mg/dl • Uncorrected hypopotassemia or hypomagnesemia • History of hypoglycemic events • History of or present cardial arrhythmia (except atrial fibrillation or paroxysmal supraventricular tachycardia) • History of Retinopathy or Maculopathy • Psoriasis • Myasthenia gravis • Immunodeficiency syndromes or need for highly immunosuppressive medication • Pre-existing medication with hydroxychloroquine • Known G6PD deficiency. • Participation in another interventional study • Known hypersensibility to hydroxychloroquine and its derivates • Subject (male or female) is not willing to use highly effective methods of contraception according to the “Clinical trial fertility group” recommendations (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf) during treatment until day 30 from first dose (adequate: combined hormonal contraceptionassociated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormonereleasing-system, bilateral tubal occlusion, vasectomized partner1, sexual abstinence2). 1 Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success2 In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject
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E.5 End points |
E.5.1 | Primary end point(s) |
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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) |
Duration of hospitalization ● Time to hospitalization ● Reason for hospitalization ● severity of disease at hospitalization All-cause mortality within 30/60 days ● COVID19 related mortality within 30/60 days ● Proportion requiring invasive ventilation ● Proportion admitted to ICU ● Rate of viral clearance defined as SARS-CoV2 specific RNA copy number <100 in throat swabs on day 7 ● Optional rate of viral clearance on d 14, 21 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
60 days after first dosis |
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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) | 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 | 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 | 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 | 2 |
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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Follow-up after treatment to day 60 |
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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |