Study population and criteria
neuromuscular impairment, RSV infection, RSV-positive, congenital heart disease, fever, prematurity, respiratory illness, renal, gastrointestinal, congenital, viral infection, cough, immunodeficiency disorders, tachypnea, bacterial co-infections
RSV INFECTION, DOWN SYNDROME, MEASLES, CYSTIC FIBROSIS, VIRAL INFECTION, BRONCHOPULMONARY DYSPLASIA, MUMPS, RUBELLA, IMMUNODEFICIENCY DISORDERS, CONGENITAL DISEASES
For the SAD/MAD Study 1, infants (≥1 to ≤12 months old) and neonates (<28 days old) of either sex, who were hospitalized and diagnosed RSV-positive based on a BINAX NOW RSV test, an RSV polymerase chain reaction (PCR), or any other RSV assay were eligible for enrollment. Hospitalized infants and children aged ≥28 days to ≤36 months with PCR-confirmed RSV infection were eligible for enrollment in Study 2.For both studies, additional criteria were signs and symptoms of acute respiratory illness consistent with a viral infection including runny nose, cough, fever, or tachypnea with an onset of ≤5 days (following amendment in Study 1) from the anticipated time of randomization. Infants diagnosed with other respiratory viral or bacterial co-infections along with RSV infection were permitted study enrollment.Infants with a history of cardiovascular, respiratory, renal, gastrointestinal, congenital, and immunodeficiency disorders were excluded. However, infants with specific comorbid conditions (prematurity at birth, bronchopulmonary dysplasia, congenital heart disease, other congenital diseases, Down syndrome, neuromuscular impairment, or cystic fibrosis) associated with severe RSV infection were permitted under Study 2. Infants who received chronic oxygen therapy or invasive endotracheal mechanical ventilation (SAD/MAD Study 1 only) or extracorporeal membrane oxygenation (Study 2 only) were excluded. Infants who received chronic immunomodulators, organic anion transporter 3 (OAT3) transporter inhibitors, recent measles, mumps, and rubella (MMR) vaccine, or prior lumicitabine or prescription medications intended to prevent or treat RSV infection itself (e.g., ribavirin, immunoglobulin, palivizumab) were also excluded.