E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Respiratory Syncytial Virus |
Virus respiratorio sincitial |
|
E.1.1.1 | Medical condition in easily understood language |
Respiratory Syncytial Virus |
Virus respiratorio sincitial |
|
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 | 20.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10038717 |
E.1.2 | Term | Respiratory syncytial viral infections |
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 |
The main objective of the study is to explore the antiviral effect of JNJ-53718678 at 2 dose levels (80 mg and 500 mg) once daily for 7 days in adults with respiratory syncytial virus (RSV) infection, as measured by RSV viral load in nasal secretions by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay. |
El objetivo principal del estudio es explorar el efecto antiviral de dos dosis de JNJ-53718678 (80 mg y 500 mg) administrado una vez al día durante 7 días en adultos con infección por el VRS, mediante la determinación de la carga viral del VRS en secreciones nasales mediante un ensayo de reacción en cadena de la polimerasa por transcripción inversa cuantitativa (qRT-PCR). |
|
E.2.2 | Secondary objectives of the trial |
- To explore in adults with RSV infection, after repeated oral dosing with JNJ-53718678: a) The safety and tolerability of JNJ-53718678; b) The impact of JNJ-53718678 on the clinical course of RSV infection; c) The pharmacokinetics of JNJ-53718678. |
Analizar en adultos con infección por el VRS después de que estos hayan recibido dosis repetidas por vía oral de JNJ-53718678: • La seguridad y tolerabilidad de JNJ-53718678 • El efecto de JNJ-53718678 en la evolución clínica de la infección por el VRS • La farmacocinética del JNJ-53718678 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female. 2. ≥18 years of age. 3. Must sign an informed consent form (ICF) indicating they understand the purpose of, and procedures required for, the study and is willing to participate in the study. Note: Prior to signing the main consent form for the study, subjects may specifically allow for the collection and testing of nasal mid-turbinate swabs by signing the pre screening (diagnostic) ICF. 4. Subjects must have an acute respiratory illness with signs and symptoms consistent with a viral infection (example, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset ≤5 days from the anticipated time of randomization. Onset of symptoms is defined as the time the subject becomes aware of the first sign and/or symptom consistent with a viral infection. Efforts should be made to determine the time of onset of symptoms as accurately as possible (in relation to routine daily activities). Note: The viral infection may present in any way as long as the underlying precipitant of the illness is considered by the investigator to be due to RSV infection. Examples of such an illness include: - An upper or lower viral respiratory tract infection (eg, “flu-like illness”); - Pneumonia; - Respiratory distress; - Asthma exacerbation; - COPD exacerbation. 5. Subject has been diagnosed with RSV infection using a rapid polymerase chain reaction (PCR) based (preferably locally available) or rapid-antigen-detection test. Note: If a patient has a positive similar diagnostic test from another study and meets all eligibility criteria for inclusion in this study, this diagnostic test result can be used for confirmation of eligibility.
Please refer to the protocol for other inclusion criteria |
1. Hombre o mujer, 2. ≥18 años de edad. 3. Deben firmar un consentimiento informado indicando que entienden el propósito de y los procedimientos requeridos para el estudio y que están dispuestos a participar en el estudio. 4. Con una enfermedad respiratoria aguda con signos y síntomas consistentes con una infección viral (p. ej., fiebre, tos, congestión nasal, secreción nasal, irritación de garganta, mialgia, letargo, dificultad respiratoria o sibilancias) con un inicio ≤ a 5 días con respecto al momento previsto de aleatorización. El inicio de los síntomas se define cómo el momento en que el paciente percibe el primer signo y/o síntoma que sea compatible con una infección vírica. Se deberá tratar de determinar el momento de aparición de los síntomas con la mayor precisión posible (en relación con las actividades diarias de rutina). La infección vírica puede presentarse de cualquier forma siempre y cuando el investigador considere que el factor precipitante subyacente de la enfermedad tiene su origen en una infección por el VRS. Ejemplos de tal enfermedad incluyen: infección vírica de las vías respiratorias superiores o inferiores, (ejemplo gripe), neumonía, dificultad respiratoria, agravamiento del asma, agravamiento de la EPOC. 5. Diagnóstico de infección por el VRS mediante una prueba de PCR rápida (preferiblemente que esté disponible en el laboratorio local) o una prueba rápida de detección de antígenos. (Si un paciente tiene un resultado positivo en una prueba diagnóstica similar de otro estudio y cumple todos los criterios de elegibilidad para la inclusión en este estudio, se podrá utilizar el resultado de esa prueba para confirmar la elegibilidad.)
Por favor refiérase al protocolo para otros criterios de inclusión. |
|
E.4 | Principal exclusion criteria |
Any potential subject who meets any of the following criteria will be excluded from participating in the study: 1. Hospitalized subjects or subjects expected to be hospitalized within 24 hours of screening. Note: Any stay in the emergency room or in the observational unit of at least 24 hours will be considered hospitalization for the purposes of the study. 2. History of or concurrent illness (beyond a comorbid condition) that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol-specified assessments. 3. Subjects who had major surgery within the 28 days prior to randomization or have planned major surgery through the course of the study. 4. Subjects who are considered by the investigator to be immunocompromised within the past 12 months, whether due to underlying medical condition (eg, malignancy or genetic disorder other than immunoglobulin A deficiency, or human immunodeficiency virus [HIV] infection) or medical therapy (eg, medications other than corticosteroids for the treatment of chronic obstructive pulmonary disease (COPD) or asthma exacerbations, chemotherapy, radiation, stem cell or solid organ transplant). 5. Subject has known or suspected chronic or acute hepatitis B or C infection.
Please refer to the protocol for other exclusion criteria |
Se excluirá de la participación en este esudio a cualquier potencial paciente que cumpla cualquiera de los siguientes criterios: 1. Hospitalizados o que se espere que sean hospitalizados en las 24 horas siguientes a la selección. A efectos de este estudio, toda estancia en el servicio de urgencias o en la unidad de observación de al menos 24 horas se considerará hospitalización. 2. Antecedentes de enfermedades simultáneas (excepto comorbilidades) que en opinión del investigador puedan confundir el resultado del estudio o suponer un riesgo adicional en la administración del fármaco del estudio al paciente o que puedan prevenir, limitar o confundir las evaluaciones específicas del protocolo. 3. Pacientes que hayan tenido una cirugía importante en los 28 días previos a la aleatorización o que tengan una cirugía importante programada durante el transcurso del estudio. 4. Inmunodeprimidos, en opinión del investigador, en los últimos 12 meses, ya sea por una enfermedad médica subyacente (p. ej., tumor o trastorno genético diferente de la deficiencia de inmunoglobulina A, o infección por el virus de la inmunodeficiencia humana [VIH]) o por tratamiento médico (p. ej., medicamentos distintos de los corticoesteroides para tratar los agravamientos de la EPOC o el asma, quimioterapia, radiación, trasplante de células madre o de órganos sólidos). 5. Diagnóstico confirmado o sospecha de infección por hepatitis B o C crónica o aguda. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. Area Under the Respiratory Syncytial Virus (RSV) Viral Load-time Curve (AUC) 2. RSV Viral Load and Change From Baseline Over Time 3. Time to Undetectable RSV Viral Load 4. Proportion of Subjects With Undetectable RSV Viral Load at Each Time Point |
1. El área bajo la curva (ABC) de la carga viral del VRS 2. La carga viral del VRS y el cambio a lo largo del tiempo con respecto a la visita basal 3. El tiempo hasta que la carga viral del VRS se vuelve indetectable 4. La proporción de pacientes con carga viral de VRS indetectable en cada momento del estudio |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Baseline through Day 3, Day 8, and Day 14 2, 3, & 4. Throughout the study (Approximately 29 days) |
1. Visita basal hasta el día 3, el día 8 y el día 14 2, 3 y 4. A lo largo del estudio (aproximadamente 29 días) |
|
E.5.2 | Secondary end point(s) |
1. Safety and Tolerability, as Assessed by Adverse Events (AEs), Clinical Laboratory Testing, ECGs, Vital Signs, Physical Examination 2. Duration and Severity of Signs and Symptoms of RSV Infection Assessed Through an Instrument for Patient-Reported Symptoms (the Respiratory Infection-Patient Reported Outcomes [RI PRO] Questionnaire) and Additional Questions About Health and Functioning 3. Time to Alleviation of Selected RSV Symptoms as Reported by the Subject 4. Respiratory Rate 5. Heart Rate 6. Body Temperature 7. Peripheral Capillary Oxygen Saturation (SpO2) 8. Predose Plasma Concentration (Ctrough) JNJ-53718678 9. Maximum Observed Concentration (Cmax) of JNJ-53718678 |
1.La seguridad y la tolerabilidad, evaluadas mediante los acontecimientos adversos (AA), los análisis de laboratorio clínicos, los electrocardiogramas (ECG), las constantes vitales y la exploración física; 2.La duración y la gravedad de los signos y síntomas de la infección por el VRS valorados mediante un cuestionario para los síntomas referidos por el paciente (el cuestionario de resultados referidos por el paciente con infección respiratoria [RCP-IR]) y preguntas complementarias acerca de la salud y el funcionamiento; 3.El tiempo transcurrido hasta la reducción de los síntomas del VRS referidos por el paciente; 4.La frecuencia respiratoria 5.Ritmo cardíaco 6.La temperatura corporal 7.La saturación de oxígeno capilar periférica (SpO2) 8. Concentración plasmática predosis de JNJ-53718678 9. Concentración máxima observada (Cmax) de JNJ-53718678 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. At baseline, Day 3, 8, 14, 21 and 28. 2. Till Day 21 3. Day 1 to 14 and Day 21 4 to 7. At baseline, Day 2 to 8, Day 14, 21 and 28. 8 & 9. Day 3 and Day 8 Exploratory End points: 1 to 9. At baseline and throughout the study (Approximately 29 days) |
1. Visita basal, Día 3, 8, 14, 21 y 28. 2. Hasta el día 21 3. Día 1 a 14 y día 21 4 a 7. Visita basal, Día 2 a 8, Día 14, 21 y 28. 8 y 9. Día 3 y día 8 Criterios de valoración exploratorios: 1 a 9. Visita basal y durante todo el estudio (Aproximadamente 29 días) |
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 3 |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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 | No |
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 |
Argentina |
Australia |
Belgium |
Brazil |
Bulgaria |
Canada |
France |
Germany |
Korea, Democratic People's Republic of |
Malaysia |
Mexico |
Poland |
Russian Federation |
South Africa |
Spain |
Sweden |
Taiwan |
Ukraine |
United States |
|
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
|
|
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 | 6 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |