E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Profliaxis of SARS-CoV-2 infection |
Profilassi dell’infezione da SARS-CoV-2 |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of the infection from Coronavirus |
Prevenzione dell'infezione da Coronavirus |
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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 |
To determine if chloroquine or hydroxychloroquine prophylaxis prevents symptomatic COVID-19 infection in health care workers or other groups at high risk. To determine if chloroquine or hydroxychloroquine prophylaxis attenuates COVID-19 infections. |
• Determinare se la profilassi con clorochina o idrossiclorochina previene l'infezione sintomatica da SARS-CoV-2 negli operatori sanitari o in altri gruppi ad alto rischio. • Determinare se la profilassi con clorochina o idrossiclorochina attenua le infezioni da SARS-CoV-2. |
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E.2.2 | Secondary objectives of the trial |
To determine if chloroquine or hydroxychloroquine prophylaxis prevents asymptomatic COVID-19 infection. To determine if chloroquine or hydroxychloroquine prophylaxis prevents all-cause symptomatic acute respiratory illnesses. To characterise genetic and baseline biochemical markers associated with symptomatic COVID-19, respiratory illness and disease severity. |
• Determinare se la profilassi con clorochina o idrossiclorochina previene l'infezione asintomatica da SARS-CoV-2. • Determinare se la profilassi con clorochina o idrossiclorochina previene le malattie respiratorie acute sintomatiche per tutte le cause. • Caratterizzare marcatori genetici e biochimici basali associati a COVID-19 sintomatico, malattia respiratoria e gravità della malattia |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Participant is willing and able to give informed consent for participation in the study and agrees with the study and its conduct • Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals • Adults (exact age is dependent on countries) • Not previously diagnosed with COVID-19 • Not currently symptomatic with an ARI • Participant A. works in healthcare facility or other well characterised high-risk environment, OR B. is an inpatient or relative of a patient in a participating hospital and likely exposed to COVID-19 infection or another high-risk group • Possesses an internet-enabled smartphone (Android or iOS) |
• Soggetti adulti che lavorano in una struttura sanitaria, senza precedente diagnosi di COVID-19, che accettano di non auto-medicarsi con clorochina, idrossiclorochina o altri potenziali antivirali • Consenso informato alla partecipazione allo studio • Attualmente non sintomatici per ARI • In possesso di uno smartphone abilitato a Internet (Android o iOS) |
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E.4 | Principal exclusion criteria |
• Hypersensitivity reaction to chloroquine, hydroxychloroquine or 4-aminoquinolines • Contraindication to taking chloroquine as prophylaxis e.g. known epileptic, known creatinine clearance < 10 ml/min • Already taking chloroquine, hydroxychloroquine or 4-aminoquinolines • Taking a concomitant medication described in section 8.5, which cannot be safely stopped • Known retinal disease • Inability to be followed up for the trial period • Known prolonged QT syndrome (however ECG is not required at baseline) |
• Ipersensibilità a clorochina, idrossiclorochina o 4-amminochinoline • Controindicazione all'assunzione di clorochina come profilassi, ad es. epilettico noto, clearance della creatinina nota <10 ml / min • Assunzione in corso di clorochina, idrossiclorochina o 4-amminochinoline • Assunzione di un farmaco concomitante non ammesso (vd. sezione 8.5 del protocollo), che non può essere interrotto in modo sicuro • Malattia retinica nota • Impossibilità ad essere seguiti per la durata dello studio • Sindrome nota del QT lungo (tuttavia non è richiesto l'ECG al basale) |
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E.5 End points |
E.5.1 | Primary end point(s) |
The number of symptomatic COVID-19 infections will be compared between the chloroquine and placebo groups. 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. |
• Numero di infezioni COVID-19 sintomatiche nei gruppi clorochina/idrossiclorochina e placebo. • Sintomi, gravità e durata di COVID-19, in coloro che vengono infettati durante lo studio, nei due gruppi, usando un punteggio di gravità. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During the clinical trial |
Durante lo svolgimento dello studio |
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E.5.2 | Secondary end point(s) |
The number of asymptomatic cases of COVID-19 will be determined by comparing acute and convalescent serology in the two groups.; The number and severity of symptomatic acute respiratory illnesses will be compared in subjects randomised to chloroquine or placebo.; Genetic loci and levels of biochemical components will be correlated with occurrence of and disease severity of COVID-19 or other ARIs. |
• Numero di casi COVID-19 asintomatici determinato mediante la sierologia acuta e convalescente nei due gruppi.; • Numero e gravità delle malattie respiratorie acute sintomatiche nei due gruppi; • I loci genetici e i livelli dei markers biochimici saranno correlati con la frequenza di COVID-19, ARI e gravità della malattia. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During clinical trial; During clinical trial; During clinical trial |
Durante lo svolgimento dello studio; Durante lo svolgimento dello studio; Durante lo svolgimento dello studio |
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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 | 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Indonesia |
Kenya |
Lao People's Democratic Republic |
Malawi |
Thailand |
Uganda |
Vietnam |
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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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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 | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |