Respiratory Syncytial Viruses
Conditions
Sponsors
Janssen Pharmaceutical K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants hospitalized (or in emergency room (ER)) at the time of randomization and unlikely to be discharged for the first 24 hours after randomization - Participants diagnosed with respiratory syncytial virus (RSV) infection using a polymerase chain reaction (PCR)-based molecular diagnostic assay, with or without co-infection with another respiratory pathogen (respiratory virus or bacteria) - Participants who have an acute respiratory illness with signs and symptoms consistent with a viral infection (for example, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or equal to <=5 days from the anticipated time of randomization. Onset of symptoms is defined as the first time (within 1 hour) the parent(s)/caregiver(s) becomes aware of respiratory or systemic symptoms of RSV infection - With the exception of the symptoms related to the RSV infection or defined comorbid condition for severe RSV disease (prematurity at birth (participant's gestational age was less than {<}37 weeks; for infants <1 year old at randomization), bronchopulmonary dysplasia, congenital heart disease, other congenital diseases, Down syndrome, neuromuscular impairment, or cystic fibrosis), participant must bemedically stable on the basis of physical examination, medical history, vital signs/peripheral capillary oxygen saturation (SpO2), and electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying condition in the study population and/or the RSV infection. This determination must be recorded in the participant's source documents and initialed by the investigator. Participants with comorbidities will be allowed to be enrolled once the Independent Data Monitoring Committee (IDMC) has reviewed the pharmacokinetic (PK) and safety data of the highest dose that will be used in this study and once the IDMC has recommended opening recruitment to this group. Sites will be notified when the restriction is lifted - The participant's estimated glomerular filtration rate (eGFR) is not below the lower limit of normal for the participant's age
Exclusion criteria
Exclusion criteria: - Participants who are not expected to survive for more than 48 hours - Participants who have had major thoracic or abdominal surgery in the 6 weeks prior to randomization - Participants who have a known or suspected immunodeficiency (except immunoglobulin A [IgA] deficiency), such as a known human immunodeficiency virus infection - Participants being treated with extracorporeal membrane oxygenation - Participant receiving chronic oxygen therapy at home prior to admission - Participants who have a poorly functioning gastrointestinal tract (that is, unable to absorb drugs or nutrition via enteral route)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load | — |
Secondary
| Measure | Time frame |
|---|---|
| - Number of Participants With Adverse Events as a Measure of Safety and Tolerability - Number of Participants With Physical Examinations Abnormalities as a Measure of Safety and Tolerability - Number of Participants With Vital Sign/Peripheral Capillary Oxygen Saturation (SpO2) Abnormalities as a Measure of Safety and Tolerability - Number of Participants With Electrocardiogram (ECG) Abnormalities as a Measure of Safety and Tolerability - Number of Participants With Laboratory Abnormalities as a Measure of Safety and Tolerability - Area Under the Plasma Concentration Time Curve (AUC) of JNJ-63549109 (Metabolite of Lumicitabine) - Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 (Metabolite of Lumicitabine) - Predicted Concentration of JNJ-63549109 (Metabolite of Lumicitabine) at 12 hours Postdose (C12h) - Length of Hospital Stay - Percentage of Participants who Require to be Admitted to Intensive Care Unit (ICU) - Duration of ICU Stay - Percentage of Participants who Require Supplemental Oxygen - Percentage of Participants who Require Noninvasive Mechanical Ventilation Support - Percentage of Participants who Require Invasive Mechanical Ventilation Support - Duration of Supplemental Oxygen - Duration of Non-invasive Mechanical Ventilation Support - Duration of Invasive Mechanical Ventilation Support - Time to no Longer Requiring Supplemental Oxygen - Time to Clinical Stability - Time From Initiation of Study Treatment Until Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to (>=)93 Percent (%) on Room Air Among Participants who Were not on Supplemental Oxygen Prior to Onset of Respiratory Symptoms - Time for Respiratory Rate to Return to Pre-RSV Infection Status - Time for SpO2 to Return to Pre-RSV Infection Status - Time for Body Temperature to Return To Pre-RSV Infection Status - Percentage of Participants With Acute Otitis Media - Duration of Signs and Symptoms of RSV Infection - Severity of Signs and Symptom | — |
Outcome results
None listed