Baloxavir for preventing flu after exposure in household contacts
Official title: A Phase III, Randomized, Double-blinded, Placebo-controlled Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis of Influenza Virus Infection in Chinese Participants
Run by Hoffmann-La Roche · NCT07827599 · Data updated 2026-11-12
A single dose of baloxavir marboxil is being tested to see if it prevents symptomatic, lab-confirmed influenza in people who live with someone who has flu symptoms.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 5 Years and up |
| Sex | All |
| Enrollment | 325 (estimated) |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Locations | 8 sites (Guangzhou, Guangdong and 7 other locations) |
| Status | Recruiting |
| Started | October 16, 2026 |
| Main results expected | April 30, 2027 |
| Study ends | April 30, 2027 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT07827599 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are household contacts of someone with laboratory-confirmed influenza who have not yet developed influenza symptoms and meet eligibility criteria.
✕Probably not a fit
Participants who already have influenza or do not meet exposure criteria may not benefit from the intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 interventional study compares a single dose of baloxavir marboxil to placebo for post-exposure prophylaxis of influenza. Participants are household contacts of someone with confirmed influenza, and includes index patients with influenza and their eligible household members. The study assesses whether baloxavir can reduce the development of influenza in exposed individuals within the current flu season. Enrollment requires constraining factors such as household size and timing of exposure, plus confirmed or suspected influenza status. Sites are located in multiple Chinese hospitals with Hoffmann-La Roche as lead sponsor.
Why it matters
Potential benefit: If successful, participants could gain protection from influenza after exposure with a convenient single-dose option.
How similar studies have gone: Prior similar approaches in PEP for influenza have shown promise, though results can vary by setting and circulating strains.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 (°C); 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
Where it's running
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Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, China Recruiting -
Mianyang Central Hospital
Mianyang, Sichuan, China Recruiting -
The First People's Hospital of Changde
Changde, China Recruiting -
Huizhou Central People's Hospital
Huizhou, China Recruiting -
Ningbo No.2 Hospital
Ningbo, China Recruiting -
Sanmenxia Central Hospital
Sanmenxia, China Recruiting
Show 2 more locations
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Huashan Hospital Affiliated to Fudan University
Shanghai, China Recruiting -
Xiamen Maternal and Child Health Hospital
Xiamen, China Recruiting
Study contacts
- Study coordinator: Roche Pharma (Schweiz) AG Reference Study ID Number: YV46459, https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. Only)
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.