RS virus infection
Conditions
Interventions
Sponsors
Gomez Juan Carlos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participant must be 18 years of age or older at the time of screening - Participants who have new onset or worsening (if present chronically) of at least 1 of the following signs and/or symptoms consistent with a viral acute respiratory infection within 72 hours prior to randomization: fever, nasal congestion, nasal discharge, sore throat, cough, sputum production, shortness of breath, or wheezing - Participants diagnosed with RSV infection - Has at least 1 of the following risk factors for severe RSV disease
Exclusion criteria
Exclusion criteria: - Hospitalized or expected to be hospitalized within 24 hours of screening - Is considered by the investigator to be immunocompromised, due to an underlying medical condition or medical therapy, chemotherapy, radiation, stem cell or solid organ transplant - Suspicion or known severe renal impairment or ongoing dialysis - Has received a therapy intended to treat RSV infection within 14 days prior to screening - Is receiving chemotherapy or immunotherapy for malignancy - Has received RSV vaccination within 7 days prior to screening - Has had either confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or influenza infection (test was positive) during the 28 days prior to screening - Has any other confirmed clinically relevant respiratory infection by any pathogen at, or within 28 days of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in RSV RNA load by qRT-PCR (nasopharyngeal swab) | — |
Countries
Argentina, Bulgaria, Japan, Poland, South Africa, Taiwan, United States, Vietnam
Contacts
Public ContactCorporate Communications Department
Shionogi & Co., Ltd.
Outcome results
None listed