Respiratory Syncytial Virus
Conditions
Sponsors
Janssen Pharmaceutical K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Hospitalized (or in emergency room prior to hospitalization) at the time of randomization and unlikely to be discharged for the first 24 hours after randomization - Diagnosed with respiratory syncytial virus (RSV) infection based on polymerase chain reaction (PCR)based assay with or without co infection with another respiratory pathogen (eg, influenza, human metapneumovirus, or bacteria) - With the exception of the RSV disease, medically stable on the basis of medical history, physical examination, vital signs, and 12lead electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying illness 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 - A woman must have a negative urine beta serum human chorionic gonadotropin at screening - A woman must agree not to donate eggs (ova, oocytes) during the study and for at least 90 days after receiving the last dose of study drug - Contraceptive use by women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies - A woman must be of nonchildbearing potential defined as either: a)Postmenopausal: a postmenopausal state is defined as more than (>) 45 years and no menses for 12 consecutive months without an alternative medical cause, OR Permanently sterile: permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures (without reversal operation), and bilateral oophorectomy. b) Of childbearing potential and, if heterosexually active, also included: practicing a highly effective method of contraception (failure rate of less than (<) 1percent (%) per year when used consistently and correctly) - Participants must have a body weight of at least 50.0 kilogram, at screening
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 are considered by the investigator to be immunocompromised within the past 12 months, whether due to underlying medical condition (example, malignancy or genetic disorder) or medical therapy (example, medications other than corticosteroids for the treatment of chronic obstructive pulmonary disease (COPD) or asthma exacerbations, chemotherapy, radiation, stem cell or solid organ transplant) - Participants with a known history of human immunodeficiency virus (HIV) or chronic viral hepatitis - Participants undergoing peritoneal dialysis, hemodialysis, or hemofiltration or with an estimated glomerular filtration rate (GFR, determined by Chronic Kidney Disease Epidemiology Collaboration [CKDEPI] equation) of (<) 60 milliliters per minute (mL/min) per 1.73 meter square (m^2) - Participants with 1 or more of the following laboratory abnormalities at screening as defined by the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table: Hemoglobin <9.5 gram per deciliter (g/dL), Platelet count <75,000 per millimeter cube (/mm^3), White blood cell count <1,000/mm^3, Absolute neutrophil count <1,000/mm^3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: PK of study drug and its Metabolites in plasma Part 2: RSV RNA viral load (measured by qRT-PCR in the mid-turbinate nasal swab specimens) AUC from immediately prior to first dose of study drug (baseline) until Day 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety/tolerability including adverse events (AEs), physical examinations, vital signs, electrocardiograms (ECGs), and clinical laboratory results Length of hospital stay from study treatment initiation to discharge Length of hospital stay from study treatment initiation to readiness for discharge Need for and duration of intensive care unit (ICU) stay Need for and duration of supplemental oxygen Number of hours until peripheral capillary oxygen saturation (SpO2) >=93 percent (%) on room air among participants who were not on supplemental oxygen prior to onset of respiratory symptoms Respiratory rate, SpO2, and body temperature return to pre-RSV disease level Need for and duration of noninvasive ventilator support and/or invasive ventilator support Time to return to pre-RSV functional status Need for hydration and feeding by intra-venous (IV) catheter or nasogastric tube Time to clinical stability Improvement on the ordinal scale Number of participants with All-cause mortality Viral load over time Peak viral load Time to peak viral load Rate of decline of viral load Time to RSV RNA being undetectable Proportion of subjects with undetectable viral load at each time point AUC of RSV RNA viral load Sequence changes (postbaseline) in the RSV polymerase L-gene and other regions (only if no mutations are seen in the L-gene) of the RSV genome compared with baseline sequences. Population-derived PK parameters of ALS-008112 | — |
Outcome results
None listed