Estudio de dos partes con una cohorte de nacimiento (etapa observacional) para el diagnóstico temprano del virus sincicial respiratorio (VSR), seguido de un estudio opcional de fase 2a, aleatorizado, doble ciego, controlado con placebo (etapa intervencionista) para evaluar la actividad antiviral, los resultados clínicos, la seguridad, la tolerabilidad y la farmacocinética de JNJ-53718678 en lactantes con infección aguda del tracto respiratorio por VSR.

CompletadoFase 2ClinicalTrials.gov

ID: NCT04068792Tipo: INTERVENTIONALInicio: 10 de oct de 2019Fin estimado: 15 de may de 2021

Resumen

El propósito de este estudio diseñado en dos partes es evaluar, en el contexto de una intercepción temprana planificada de la enfermedad pediátrica por VSR, la cinética viral y de la enfermedad temprana (etapa observacional) y los efectos antivirales de un inhibidor de fusión del virus sincicial respiratorio (VSR), JNJ-53718678 (etapa intervencionista). En la etapa observacional, el lactante es monitoreado de cerca por el/los padre(s)/cuidador(es) para detectar síntomas tempranos y, por lo tanto, puede ser llevado para el diagnóstico más tempranamente que en el contexto habitual.

Elegibilidad

Edad mínima: 28 DaysEdad máxima: 4 MonthsSexo: ALL

Criterios de inclusión

Part 1: Observational Stage
The infant is less than or equal to (\<=) 4 months of age at enrollment and asymptomatic for acute respiratory illness (ARI)-like symptoms requiring medical intervention at the time of consent to participate in the study
At least 1 parent/caregiver must be able to use the respiratory syncytial virus (RSV) mobile application (App) at home via his/her own Android/iOS electronic device (compatible with RSV mobile App)
The participant must have been assessed per local public health practice and considered not to have Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
Part 2: Interventional Stage
The infant is 28 days and if prematurely born infant (that is \[i.e.\], less than \[\<\] 37 weeks and 0 days of gestation at birth) is at least 3 months postnatal age
The participant has been diagnosed with RSV infection using a rapid molecular-based diagnostic assay
The participant weighs more than 2.4 kilogram (kg)
The participant has an acute respiratory illness as evaluated by the investigator
Except for the RSV-related illness, the participant must be medically stable in case of allowed co-morbid conditions
The participant must have been assessed per local public health practice and considered not to have SARS-CoV-2 infection during this respiratory infection

Criterios de exclusión

Part 1: Observational Stage
The participant has any physical abnormality which limits the ability to collect regular nasal specimens
The participant is receiving chronic home oxygen therapy at enrollment (applicable to both parts)
Part 2: Interventional Stage
The participant is \<3 months postnatal age at screening and was born prematurely (i.e., \<37 weeks and 0 days of gestation) or if the participant weights \<2.4 kg
The participant has a QT interval with Fridericia's correction (QTcF) greater than (\>) 450 milliseconds per the machine read (mean of triplicate) parameter result confirmed by repeat triplicate Electrocardiogram (ECG) recording during screening
The participant is considered by the investigator to be immunocompromised, whether due to underlying medical condition or medical therapy
The participant has had any of: a) Confirmed SARS-CoV-2 infection (test positive) during the four weeks prior to randomization, or b) Close contact with a person with Coronavirus Disease 2019 (COVID-19) (test confirmed or suspected SARS-CoV-2 infection) within 14 days prior to randomization

Intervenciones

other

RSV Mobile Application

Participants will not receive any intervention in observational phase of this study. Participant's respiratory symptoms will be captured by RSV mobile application installed in participant's caregiver/parent mobile phone.

drug

Placebo

Participants in each Age Group (1,2,3) will receive matching placebo (volume placebo to match the calculated volume of the JNJ-53718678 dose) orally twice daily for 7 days.

drug

JNJ-53718678 2.5 mg/kg

JNJ-53718678 will be administered to Age Group 1 twice daily for 7 days.

drug

JNJ-53718678 3 mg/kg

JNJ-53718678 will be administered to Age Group 2 twice daily for 7 days.

drug

JNJ-53718678 4.5 mg/kg

JNJ-53718678 will be administered to Age Group 3 twice daily for 7 days.

Ubicaciones

Instituto de Maternidad y Ginecología Nuestra Senora de las Mercedes

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalJanssen Research & Development, LLC

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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