E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients diagnosed with COVID-19, with positive PCR for SARS-CoV-2, without criteria for hospital admission. |
Pacientes diagnosticados de COVID-19, con PCR para SARS-CoV-2 positiva, sin criterios para ingreso hospitalario. |
|
E.1.1.1 | Medical condition in easily understood language |
Patients diagnosed with COVID-19, with positive PCR for SARS-CoV-2, without criteria for hospital admission. |
Pacientes diagnosticados de COVID-19, con PCR para SARS-CoV-2 positiva, sin criterios para ingreso hospitalario. |
|
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 | 10084401 |
E.1.2 | Term | COVID-19 respiratory infection |
E.1.2 | System Organ Class | 100000004862 |
|
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 |
Efficacy in reducing the number of hospital admissions for pneumonia among patients debuting with a mild form of the disease. |
Eficacia en la reducción de número de ingresos hospitalarios por neumonía entre los pacientes que debutan con una forma leve de la enfermedad. |
|
E.2.2 | Secondary objectives of the trial |
1. 60-day mortality. 2. Admission to the Intensive Care Unit. 3. Safety of hydroxychloroquine treatment in this population |
1. Mortalidad a 60 días. 2. Ingreso en Unidad de Cuidados Intensivos. 3. Seguridad del tratamiento con hidroxicloroquina en esta población |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Ability of understanding the terms of the trial and willingness to participate. 2. Signature of the informed consent or oral consent with subsequent written confirmation in accordance with the provisions of section 8.4.1 of the study protocol. 3. Age ≥50 years. 4. SARS-CoV-2 positive PCR in nasopharyngeal and / or oropharyngeal or sputum specimen. 5. Duration of symptoms ≤ 5 days. 6. Absence of contraindications to the use of hydroxychloroquine: intolerance, allergy, major interactions with home medication. |
1. Pacientes capaces de entender los términos del ensayo y que acepten participar en el mismo. 2. Firma del Consentimiento informado o consentimiento oral con confirmación posterior por escrito de acuerdo a lo indicado en el apartado 8.4.1 3. Edad ≥50 años. 4. PCR positiva para SARS-CoV-2 en muestra nasofaríngea y/u orofaríngea o de esputo. 5. Duración de sintomatología ≤ 5 días. 6. Ausencia de contraindicaciones para el empleo de hidroxicloroquina: intolerancia, alergia, interacciones mayores con su medicación habitual. |
|
E.4 | Principal exclusion criteria |
1. Indication of hospital admission, defined by: to. Presence of pulmonary infiltrate or significant hypoxemia (pO2 <70, SO2 <95%). b. Symptoms suggestive of lower respiratory involvement (increasing cough, dyspnea and / or pleuritic pain), even in the absence of radiological or gasometric criteria, according to clinical criteria. c. Any other justification that at the discretion of the investigator motivates hospital admission. 2. Current treatment or in the last 14 days with hydroxychloroquine for any indication. 3. History of ischemic heart disease, bradyarrhythmias, ventricular arrhythmias, preexcitation syndrome (Wolf-Parkinson-White syndrome), patients receiving antiarrhythmic drugs or defibrillator carriers. 4. Baseline QTc ≥ 470 ms in men or ≥ 480 ms in women (on current ECG or on ECG of the 3 months prior to study inclusion). 5. Current treatment with drugs that can prolong the QT interval, such as: loperamide, antiemetics, antipsychotics, antidepressants, cilostazol, donezepil, alfuzosin, solifenacin, quinolones, azoles, opiates. According to medical criteria, a temporary discontinuation of the previous treatment may be assessed, if it is the only limiting factor for participation in the study and its discontinuation or replacement does not pose a risk to the patient. 6. Patients who are participating in another clinical trial. |
1. Indicación de ingreso hospitalario, definido por: a. Presencia de infiltrado pulmonar o hipoxemia significativa (pO2 <70, SO2<95%). b. Sintomatología sugestiva de afectación respiratoria baja (tos creciente, disnea y/o dolor pleurítico), aún en ausencia de criterios radiológicos o gasométricos, según criterio clínico. c. Cualquier otra justificación que a criterio del médico motive el ingreso hospitalario. 2. Tratamiento actual o en los últimos 14 días con hidroxicloroquina por cualquier indicación. 3. Historia de cardiopatía isquémica, bradiarritmias, arritmias ventriculares, síndrome de preexcitación (Síndrome de Wolf-Parkinson-White), pacientes a tratamiento con antiarrítmicos o portadores de desfibrilador. 4. QTc basal≥ 470 ms en hombres o ≥ 480 ms en mujeres (en ECG actual o en ECG de los 3 meses anteriores a la inclusión al estudio). 5. Tratamiento actual con fármacos que puedan prolongar el intervalo QT, como por ejemplo: loperamida, antieméticos, antipsicóticos, antidepresivos, cilostazol, donezepilo, alfuzosina, solifenacina, quinolonas, azoles, opiáceos. Según criterio médico, se podrá valorar una discontinuación temporal del tratamiento previo, si es el único factor limitante para la participación en el estudio y su discontinuación o sustitución no supone un riesgo para el paciente. 6. Pacientes que estén participando en otro ensayo clínico. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Hospitalization rate. |
Tasa de ingresos en planta de hospitalización. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
60 days from treatment onset |
60 días desde el inicio de tratamiento |
|
E.5.2 | Secondary end point(s) |
1- Death rate related to COVID-19. Related to COVID-19 death is defined as: death caused by respiratory failure, acute respiratory distress syndrome, multiple organ failure, or any other serious complication during the course of an acute SARS-CoV-2 infection. 2- Income rate in the Intensive Care Unit. 3- Percentage and type of adverse events collected. |
1- Tasa de éxitus por COVID-19. Se define fallecimiento o muerte por COVID cuando este se produce por insuficiencia respiratoria, síndrome de distress respiratorio agudo, fallo multiorgánico o cualquier otra complicación grave, en el transcurso de la evolución de una infección aguda por SARS-CoV-2. 2- Tasa de ingresos en Unidad de Cuidados Intensivos. 3- Porcentaje y tipo de eventos adversos recogidos. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
60 days from treatment onset |
60 días desde el inicio de 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 | 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) | 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
|
The day of the final visit (telephone contact) of the last patient included in the study will be considered the end of the study. Given the changing situation of the protocols in covid19, the sponsor and investigators of the trial undertake to end the study if scientific evidence recommends a clear different attitude in this study population. |
Se considerará final del estudio el día de la visita final (contacto telefónico) del último paciente incluido en el estudio. Dada la situación cambiante de los protocolos en covid19, El promotor e investigador del ensayo se comprometen a finalizar el estudio si surgen evidencias científicas que recomienden una actitud diferente clara en esta población de estudio. |
|
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 | |