E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
SARS COVID-19 |
SARS COVID-19 |
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E.1.1.1 | Medical condition in easily understood language |
Coronavirus infection |
Infección por coronavirus |
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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 |
Demonstrate the effectiveness of Ivermectin in the prophylaxis and treatment of COVID-19 |
Demostrar la efectividad de la Ivermectina en la profilaxis y tratamiento de la COVID-19 |
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E.2.2 | Secondary objectives of the trial |
not applicable |
not applicable |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Sub-study 1: Tittle:Demonstrate the Efficacy of Ivermectin in the treatment of SARS-CoV-2 Specific Objective:. Compare the viral clearance in SARS-CoV-2 patients treated with Ivermectin and placebo. Secondary objective: Compare the clinical evolution and complications between COVID-19 patients receiving Ivermectin and placebo
Sub-study 2: Tittle: Demonstrate Ivermectin efficacy in contact prophylaxis Specific objective: Compare the contagion rate between home contacts of patients with COVID-19 + receiving prophylaxis with Ivermectin and placebo Secondary objective: Compare the clinical evolution and complications between home contacts of COVID-19 + patients receiving Ivermectin and Placebo prophylaxis. |
Subestudio 1: Título: Demostrar la Eficacia de la Ivermectina en el tratamiento del SARS-CoV-2 Objectivo específico:Comparar el viral clearance en pacientes de SARS-CoV-2 en tratamiento con Ivermectina y placebo. Objetivo secundario: Comparar la evolución clínica y complicaciones entre pacientes de COVID-19 en tratamiento con Ivermectina y placebo
Subestudio 2: Título: Demostrar eficacia Ivermectina en la profilaxis de los contactos Objetivo específico: Comparar la tasa de contagio entre contactos domiciliarios de pacientes con COVID-19+ que reciban profilaxis con Ivermectina y placebo Objetivo secundario: Comparar la evolución clínica y complicaciones entre contactos domiciliarios de pacientes COVID-19+ que reciban profilaxis con Ivermectina y Placebo. |
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E.3 | Principal inclusion criteria |
Sub-study 1: 1. Symptomatic (respiratory) patients with a positive PCR-RT test for COVID-19 and a clinical condition of less than 5 days of evolution. 2. ≥18 years old. 3. In women of childbearing age, negative pregnancy test and use of contraceptive method during the study period. 4. Accept to take the medication and the complementary test procedures during the study, including analysis and nasal sampling. 5. Able to provide informed consent (oral or written).
Sub-study 2: 1. Contacts of symptomatic (respiratory) patients with a positive PCR-RT test for COVID-19 and a diagnosis of less than 5 days of evolution. 2. Of legal age. 3. In women of childbearing age, negative pregnancy test and use of contraceptive method during the study period. 4. Accept to take the medication and the complementary test procedures during the study, including analysis and nasal sampling. 5. Able to provide informed consent (oral or written). |
Subestudio 1 1. Pacientes sintomáticos (respiratorios) con test PCR-RT positive por COVID-19 y clínica inferior a 5 días de evolución. 2. Mayores de edad (≥18 años). 3. En mujeres en edad fértil prueba de embarazo negativo y uso de método anticonceptivo durante el periodo de estudio. 4. Aceptar tomar la medicación y los procedimientos de pruebas complementarias durante el estudio incluido analítica y toma de muestras nasales. 5. Capaz de proveer consentimiento informado (oral o escrito).
Subestudio 2 1. Contactos de pacientes sintomáticos (respiratorios) con test PCR-RT positiva por COVID-19 y diagnóstico inferior a 5 días de evolución. 2. Mayores de edad. 3. En mujeres en edad fértil prueba de embarazo negativo y uso de método anticonceptivo durante el periodo de estudio. 4. Aceptar tomar la medicación y los procedimientos de pruebas complementarias durante el estudio incluido analítica y toma de muestras nasales. 5. Capaz de proveer consentimiento informado (oral o escrito). |
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E.4 | Principal exclusion criteria |
Sub-study 1 1. Moderate or severe forms of infection requiring hospital admission a.-Respiratory distress with respiratory rate> = 30 breaths / min b.-Oxygen saturation ≤93% at rest c.- Kirby index:(PaO2) /(FIO2)) ≤300mmHg. 2. Participants taking medications that may interfere with the study medication such as anticoagulants. 3. Inability to take oral medication. 4. Severe liver disorders (Child Pugh C). 5. Impairment of severe renal function (with GFR ≤30 mL / min / 1.73 m2) or requiring dialysis. 6. Participants with coagulation disorders. 7. Individuals with severe neurological or mental impairment. 8. Pregnant or lactating women. 9. Unable to consent to the study protocol. 10. People with known hypersensitivity to Ivermectin. 11. People who have been treated in any other study in the previous 30 days. 12. Concomitant administration of enzyme inducers (such as carbamazepine) that could affect the effectiveness of the drug and those receiving CYP3A4 substrates (such as statins) due to the risk of increased toxicity. 13. Any other contraindication according to the technical sheet for Ivermectin.
Sub-study 2 1. Participants taking medications that may interfere with study medication. 2. Inability to take oral medication. 3. Severe liver disorders (Child Pugh C) or alcoholism. 4. Impaired severe renal function (with GFR ≤30 mL / min / 1.73 m2) or requiring dialysis. 5. Participants with coagulation disorders. 6. Individuals with severe neurological or mental impairment. 7. Pregnant or lactating women. 8. Unable to consent to study protocol. 9. People with known hypersensitivity to Ivermectin. 10. People who have been treated in any other study in the previous 30 days. 11. Concomitant administration of enzyme inducers (such as carbamazepine) that could affect the effectiveness of the drug and those receiving CYP3A4 substrates (such as statins) due to the risk of increased toxicity. 12. Any other contraindication according to the technical data sheet for Ivermectin. |
Subestudio 1 1. Formas moderadas o graves de la infección que requieran ingreso hospitalario a.-Distrés respiratorio con frecuencia respiratoria >=30 respiraciones/min b.-Saturación de oxígeno ≤93% en reposo c.-Índice PAFI (Presión arterial de oxígeno (PaO2)/ fracción inspirada de oxígeno (FIO2) ) ≤300mmHg. 2. Participantes que tomen medicaciones que puedan interferir con la medicación del estudio como los anticuagulantes. 3. Incapacidad de tomar medicación oral. 4. Alteraciones hepáticas severas (Child Pugh C). 5. Afectación de la función renal grave (con FG ≤30 mL/min/1.73 m2) o que requiera diálisis. 6. Participantes con alteraciones de la coagulación. 7. Individuos con afectación neurológica o mental grave. 8. Mujeres embarazadas o en periodo de lactancia. 9. Incapaz de dar consentimiento al protocolo de estudio. 10. Personas con hipersensibilidad conocida a la Ivermectina. 11. Personas que hayan sido tratadas en cualquier otro estudio en los 30 días previos. 12. Administración concomitante de inductores enzimáticos (como la carbamazepina) que podrían afectar la efectividad del medicamento y aquellos que reciben sustratos de CYP3A4 (como estatinas) debido al riesgo de aumento de la toxicidad. 13. Cualquier otra contraindicación según ficha técnica para la Ivermectina.
Subestudio 2
1. Participantes que tomen medicaciones que puedan interferir con la medicación del estudio. 2. Incapacidad de tomar medicación oral. 3. Alteraciones hepáticas severas (Child Pugh C) o alcoholismo. 4. Afectación de la función renal grave (con FG ≤30 mL/min/1.73 m2) o que requiera diálisis. 5. Participantes con alteraciones de la coagulación. 6. Individuos con afectación neurológica o mental grave. 7. Mujeres embarazadas o en periodo de lactancia. 8. Incapaz de dar consentimiento al protocolo de estudio. 9. Personas con hipersensibilidad conocida a la Ivermectina. 10. Personas que hayan sido tratadas en cualquier otro estudio en los 30 días previos. 11. Administración concomitante de inductores enzimáticos (como la carbamazepina) que podrían afectar la efectividad del medicamento y aquellos que reciben sustratos de CYP3A4 (como estatinas) debido al riesgo de aumento de la toxicidad. 12. Cualquier otra contraindicación según ficha técnica para la Ivermectina. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Sub-study 1 Virological clearence at 3, 6, 9 and 12 days after starting treatment with Ivermectin
Sub-study 2 Incidence of secondary cases diagnosed by molecular biology and serology on the 7th, 14th, 21st day after starting prophylaxis with Ivermectin and with placebo |
Subestudio 1 Presencia / ausencia de carga viral al 3, 6, 9 i 12 día después de iniciar el tratamiento con Ivermectina (virological clearance)
Subestudio 2 Incidencia de casos secundarios mediada a través de diagnóstico por biología molecular y serología al 7, 14, 21º día después de iniciar la profilaxis con Ivermectina y con placebo |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Sub-study 1 Day 3rd, 6th, 9th and 12th after starting treatment
Sub-study 2 Day 7th, 14, 21th after starting treatment |
Subestudio 1 Dia 3, 6, 9, 12 después de iniciar tratamiento
Subestudio 2 Dia 7, 14, 21 después de iniciar el tratamiento |
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E.5.2 | Secondary end point(s) |
Sub-study 1 1. Viral load at 3, 6, 9 and 12 days after starting treatment with Ivermectin and placebo (virological clearance). 2. Serological response at 6 and 14 days 3. Morbidity and Mortality at 14 days 4. Incidence of infection between household contacts 5. Analytical values at 0 (baseline), 6 and 12 days 6. Proportion of participants leaving the study 7. Proportion of participants not complying with the study protocol
Sub-study 2 1. Morbidity and mortality at 28 days 2. Analytical values at 0 (baseline), 7, 12 and 21 days |
Subestudio 1 1. Carga viral al 3, 6, 9 i 12 día después de iniciar el tratamiento con Ivermectina y placebo (virological clearance). 2. Respuesta serológica a los 6 y 14 días 3. Morbilidad y Mortalidad a los 14 días 4. Incidencia de infección entre contactos domiciliares 5. Valores analíticos a los 0 (basal), 6 y 12 días 6. Proporción de participantes que abandonan estudio 7. Proporción de participantes que no cumplen protocolo del estudio
Subestudio 2 1. Morbilidad y mortalidad a los 28 días 2. Valores analíticos a los 0 (basal), 7, 12 y 21 días |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Sub-study 1 Day 3rd, 6th, 9th, 12th and 14 after starting treatment
Sub-study 2 Day 0, 7th, 12, 21th and 28th after starting treatment |
Subestudio 1 Dia 3, 6, 9, 12 y 14 después de iniciar tratamiento
Subestudio 2 Dia 0, 7, 12, 21 y 28 después de iniciar el tratamiento |
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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 | 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 | 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 | 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
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LVLS |
ültima visita, último sujeto |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |