E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of SARS-CoV-2 (COVID-19) infection |
Prevención de la infección por SARS-CoV-2 (COVID-19) |
|
E.1.1.1 | Medical condition in easily understood language |
Prevention of COVID-19 infection |
Prevención de la infección por COVID-19 |
|
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 |
To assess the efficacy of hydroxychloroquine preventive administration in healthcare personnel with risk of exposure to COVID-19 infected patients. |
Demostrar la eficacia de la administración preventiva de hidroxicloroquina en el personal sanitario en contacto con pacientes con infección COVID-19 para reducir la tasa de contagio. |
|
E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability of preventive use of hydroxychloroquine in healthcare personnel. |
Evaluar la seguridad y tolerabilidad de la utilización preventiva de la hidroxicloroquina en el personal sanitario. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthcare personnel (doctor, nurse, nursing assistant or hospital porter) with risk of exposure to SARS-CoV-2 infected or probably infected patients. |
Profesional sanitario (médico, enfermera, auxiliar de enfermería o celador) con actividad laboral en unidades clínicas hospitalarias donde se atienden pacientes con infección probable o confirmada por SARS-CoV-2. |
|
E.4 | Principal exclusion criteria |
Age under 18. Weight under 40Kg Pregnancy Contraindications for the use of hydroxychloroquine (allergy, retinal disease, myasthenia gravis...) |
Contraindicaciones para el uso de hidroxicloroquina: alergia a hidroxicloroquina, enfermedad de la retina, enfermedad de motoneurona como miastenia gravis) Peso < 40 kg Embarazo o riesgo de estar embarazada Edad menor de 18 años |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Decrease of the contagion rate measured by RT-PCR of healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 3% in experimental group. - Decrease of the incidence of coronavirus disease (COVID-19) in the healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 3% in experimental group. |
- Reducción de la tasa de contagio medida mediante RT-PCR del personal sanitario que atiende a pacientes con infección activa por SARS-CoV-2 desde un 9% en el grupo control al 3% en el grupo experimental. - Reducción la incidencia de enfermedad COVID-19 en el personal sanitario que atiende a pacientes con infección activa por SARS-CoV-2 desde un 9% en el grupo control al 3% en el grupo experimental. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At the end of treatment (day 60) |
Al final del tratamiento (día 60) |
|
E.5.2 | Secondary end point(s) |
- Decrease of the contagion rate measured by RT-PCR of healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 5% in experimental group. - Decrease of the incidence of coronavirus disease (COVID-19) in the healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 5% in experimental group. - Decrease of the seroconversion rate in the healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 5% in experimental group. - Decrease of temporary work disability (TWD) and/or the employee absenteeism at the end of the study from 9% in control group to 5% in experimental group - Safety: presence of adverse events |
- Reducción de la tasa de contagio medida mediante RT-PCR del personal sanitario que atiende a pacientes con infección activa por SARS-CoV-2 desde el 9% en el grupo placebo al 5% en el grupo experimental. - Reducción de la incidencia de enfermedad COVID-19 en el personal sanitario que atiende a pacientes con infección activa por SARS-CoV-2 desde el 9% en el grupo placebo al 5% en el grupo experimental. - Reducción de la tasa de seroconversión frente al SARS-CoV-2 en el personal sanitario que atiende a pacientes con infección activa por SARS-CoV-2 desde el 9% en el grupo placebo al 5% en el grupo experimental. - Reducción en de la incapacidad laboral transitoria (ILT) y/o el absentismo laboral por cualquier causa al finalizar el estudio desde el 9% en el grupo placebo al 5% en el grupo experimental - Seguridad: presencia de eventos adversos |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At the end of treatment (day 60) Safety will be evaluated at day 15, 30 and 60. |
Al final del tratamiento (día 60) La seguridad será evaluada los días 15, 30 y 60 desde el inicio del tratamiento. |
|
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 | 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) | 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
| 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
|
LVLS |
Última visita del último paciente incluido |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |