Oseltamivir and Baloxavir Marboxil for Prophylaxis Against Influenza Under a Hospital-based Setting
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2+
SponsorCapital Medical University
About this trial
This study aims to randomly assign close contacts of hospitalized influenza virus patients to receive baloxavir marboxil prophylaxis, oseltamivir prophylaxis or no antiviral prophylaxis and monitor the incidence of clinical influenza, evaluating the prophylaxis efficiency of antivirals in a hospital setting.
Eligibility criteria
Qualifiers
1. Patients or accompanying caregivers hospitalized at participating medical institutions.
2.The subject and/or their legal guardian both agree to participate in this clinical study, sign the informed consent form, and are able to comply with the study requirements for follow-up and completion of all study procedures and assessments.
3.Age ≥ 2 years.
4.Influenza nucleic acid positivity confirmed by throat swab, sputum and other respiratory sample through rapid antigen testing (RAT) or PCR.
Disqualifiers
Close contacts
1.With known allergies to the active ingredients or excipients of the investigational drug.
2.Close contacts diagnosed with or having experienced an influenza virus infection within the past 12 weeks.
3.Close contacts who have used antiviral drugs (including neuraminidase inhibitors, hemagglutinin inhibitors, and M2 ion channel blockers, such as oseltamivir, zanamivir, peramivir, favipiravir, abidol, baloxavir marboxil, amantadine, rimantadine, or any other antiviral drugs approved by NMPA) within the 2 weeks prior to screening.
Trial design
Treatments tested in this trial
- Baloxavir Marboxil
- Oseltamivir
Treatment groups
372 Participants
are divided into 3 treatment groupsSponsors and collaborators
Capital Medical University
Lead sponsor
China-Japan Friendship Hospital
Collaborator
Chinese Academy of Medical Sciences
Collaborator
Source ClinicalTrials.gov