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A Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis (PEP) of Influenza Virus Infection in Chinese Participants

RecruitingPhase 3Ages 5 Years - anyAllHoffmann-La Roche
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In plain words

What the trial is, and whether it could suit you

The main purpose of the study is to evaluate the efficacy of a single dose of baloxavir marboxil compared with placebo in the PEP of influenza virus infection with respect to symptomatic, laboratory-confirmed influenza in participants who are household contacts (HHCs) of participants with influenza (index participants).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Index Participants (Participants With Influenza Virus Infection): * First participant in a household with influenza virus infection in the current influenza season * Fewer than 6 HHCs * Agreement by all household members to participate in the study and comply with the study protocol for the duration of the study * Diagnosed as having influenza with positive rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) result * Onset of symptoms within 48 hours or less at time of signing Informed Consent Form (ICF)/Assent Form * PCR (-) or antigen test (-) for severe acute respiratory virus-coronavirus 2 (SARS-CoV-2) using point-of-care or local laboratory test HHCs of Index Participants: * Lived with the index participant for 48 hours or more prior to informed consent/assent * Meet all the following criteria and are judged not to have influenza virus infection by the investigator: body temperature (tympanic) \<37.5 degrees Celsius (ยฐC); no influenza-like symptoms (cough, sore throat, headache, nasal discharge/nasal congestion, feverishness or chills, muscle or joint pain, or fatigue) at screening; negative RIDT or PCR result for influenza * For participants 12 years of age or older, ability to evaluate influenza symptoms by using a participant influenza symptoms diary; For participants under 12 years of age, capability of parents/caregivers to evaluate influenza symptoms by using a participant influenza symptoms diary * PCR (-) or antigen test (-) for SARS-CoV-2 using point-of-care or local laboratory test Exclusion Criteria: HHCs of Index Participants: * Diagnosed with influenza during the current influenza season * Unable to live with the index patient from screening until Day 10 * Live with a household member who has any influenza-like symptom(s) other than the index participant on the day of screening * Live with household members other than the index participant who was diagnosed with or strongly suspected to have influenza during the current influenza season * Have any underlying diseases requiring systemic (oral or injection), or nasal treatment of antipyretics/analgesics, corticosteroids, or immunosuppressive agents * Immunocompromised * Use of any medications with anti-influenza effect within 30 days prior to screening * Known allergy and/or history of significant intolerance against baloxavir marboxil * Exposure to an investigational drug within 30 days or 5 half-lives of the drug prior to screening, whichever is longer Note: Other protocol-defined inclusion/exclusion criteria may apply
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What it tests

  • Baloxavir marboxil
  • Placebo
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Where

8 sites
Zhujiang Hospital, Southern Medical University
Guangzhou, China
Mianyang Central Hospital
Mianyang, China
The First People's Hospital of Changde
Changde, China
Huizhou Central People's Hospital
Huizhou, China
Ningbo No.2 Hospital
Ningbo, China
Sanmenxia Central Hospital
Sanmenxia, China
Huashan Hospital Affiliated to Fudan University
Shanghai, China
Xiamen Maternal and Child Health Hospital
Xiamen, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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