A Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus
Condition: Respiratory Syncytial Viruses
MeSH terms: Virus Diseases
Intervention: Lumicitabine; Placebo
Intervention description: Participants will receive oral administration of lumicitabine.; Participants will receive oral administration of matching placebo.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 7.0
Sex: All
Minimum age: 28 Days
Maximum age: 36 Months
Healthy volunteers: No

Summary:

      The purpose of this study is to determine in hospitalized infants and children who are
      infected with respiratory syncytial virus (RSV) the dose-response relationship of multiple
      regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative
      real-time reverse transcriptase polymerase chain reaction (qRT-PCR).
    

Eligibility 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 be medically 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:

          -  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)