Day | 1 | 2 +1 day | 3 | 4 | 5 -1 to +2 days | 6 | 7 | 8 | 9 | 10 −1 to +4 days 4 | Discontinuation +14 days | |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Visit | 1a | 2 | 3 | |||||||||
Pre dose | Post dose | |||||||||||
Informed consent | X | |||||||||||
Inclusion/exclusion criteria | X | |||||||||||
Demographics, clinical characteristics, and medical history | X | |||||||||||
Enrollment and randomization | X | |||||||||||
Baloxavir administration | X | |||||||||||
Oseltamivir administration | X | X | X | X | X | |||||||
Diary (ePRO) | ||||||||||||
Body temperature | X | Xa | qid | bid | ||||||||
Influenza symptom severity | X | Xa | bid | |||||||||
Medical examinationb | X | X | X | X | X | |||||||
Vital signs | X | X | X | X | X | |||||||
Influenza RIDT | Xc | |||||||||||
SARS-CoV-2 test | Xd | Xe | ||||||||||
Influenza virus tests (RT-PCR, titer, RNA, PA, or NA sequence) | X | X | X | X | X | |||||||
Influenza virus serum antibody titer test (HI method) | X | |||||||||||
Intrahousehold influenza infection rate questionnaire | X | X | ||||||||||
TEAE reporting | X | X | X | X | X | X | X | X | X | X | X | X |