Metapneumovirus
Conditions
Sponsors
Janssen Pharmaceutical K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants 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 - Participants diagnosed with human metapneumovirus (hMPV) infection using a rapid polymerase chain reaction (PCR)-based molecular diagnostic assay, with or without coinfection with another respiratory pathogen (respiratory virus or bacteria) - Participants with 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 - With the exception of the symptoms related to hMPV infection, participants must be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population, and/or the hMPV infection. This determination must be recorded in the participant's source documents and initialed by the investigator - A woman must have a negative urine pregnancy test (beta-human chorionic gonadotropin [b-hCG]) 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 (for example, malignancy or genetic disorder) or medical therapy (for 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 undergoing peritoneal dialysis, hemodialysis, or hemofiltration or with an estimated glomerular filtration rate (GFR, determined by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) of (<) 60 milliliters per minute (mL/min) per 1.73 meter square (m^2) - Participants with a known history of human immunodeficiency virus (HIV) or chronic viral hepatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Concentration-Time Curve (AUC) of Human Metapneumovirus (hMPV) Viral Load Baseline up to Day 7 The AUC of hMPV ribonucleic acid (RNA) logarithm base 10 (log10) viral load (measured by quantitative real time reverse transcriptase polymerase chain reaction [qRT-PCR] in the mid-turbinate nasal swab specimens) is estimated by analyzing mean log10 viral load values over time using a restricted maximum likelihood based repeated measures approach. Baseline up to Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability Up to 28 days Number of Participants with an Abnormal Physical Examination Findings (Height, Body Weight, Respiratory System, Nose, Ear, Throat, Facial and Neck Lymph Nodes, and Skin Examination) as a Measure of Safety and Tolerability Up to 28 days Number of Participants with an Abnormal Vital Signs/Peripheral Capillary Oxygen Saturation (SpO2) Reading as a Measure of Safety and Tolerability Up to 28 days Number of Participants with an Abnormal Electrocardiogram (ECG) Reading as a Measure of Safety and Tolerability Up to 28 days Number of Participants with Clinical Laboratory Abnormalities as a Measure of Safety and Tolerability Up to 28 days Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 Dose 1: 0.5 to 1 hour postdose, and 2 to 3 hours postdose; Dose 2: predose, and 3 to 6 hours postdose; Dose 3 and 10: predose Concentration at 12 Hours Postdose (C12h) of JNJ-63549109 Days 1, 2, and 5/6: 12 hours postdose Area Under the Plasma Concentration-Time Curve (AUC) of JNJ-63549109 Dose 1: 0.5 to 1 hour postdose, and 2 to 3 hours postdose; Dose 2: predose, and 3 to 6 hours postdose; Dose 3 and 10: predose Ordinal Scale Day of last dose (Day 5 or Day 6) Length of Hospital Stay from Admission to Discharge From admission to discharge (Up to 28 days) Length of Hospital Stay from Admission to Readiness for Discharge From admission to readiness for discharge discharge (Up to 28 days) Length of Hospital Stay from Study Treatment Initiation to Discharge From study treatment initiation to discharge (Up to 28 days) Length of Hospital Stay from Study Treatment Initiation to Readiness for Discharge From study treatment initiation to readiness for discharge (Up to 28 days) Percentage of Participants Requiring Admission to the Intensive Care Unit (ICU) Up to 28 days Duration of ICU Stay Up to 28 days Percentage of Participants Requiring Oxygen Supplementation/Noninvasive Mechanical Ve | — |
Outcome results
None listed