One pill to stop the flu from spreading at home? a new trial puts sebaloxavir to the test.
NCT ID NCT07730346
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This phase 3 trial is testing whether a single dose of the antiviral drug sebaloxavir marboxil can prevent influenza in household members (ages 2 and up) who live with someone recently diagnosed with the flu. Participants are randomly assigned to receive either the drug or a placebo, and researchers track who develops a confirmed flu infection with symptoms. The goal is to see if this one-time treatment can safely stop the virus from spreading within a home.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a single dose of an antiviral drug called sebaloxavir marboxil, given as tablets or oral suspension
- What this could lead to
- If it works, this could offer a simple, one-dose way to stop the flu from spreading within a household after someone gets sick.
- What could go wrong
- This is an early-phase 3 trial, so the drug may not prove effective or safe enough for prevention. Side effects are possible, and results in a controlled trial may not reflect real-world use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 858 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Index Participants: Inclusion Criteria: * 1\. The index participant (aged ≥18 years), or the index participant (aged \<18 years) together with their legal guardian, understands and voluntarily provides written informed consent form (ICF). The index participant must be ≥1 year of age at the time of ICF signing, with no gender restriction. * 2\. The index participant must be the first case of influenza virus infection in the household during the current influenza season. * 3\. The index participant must have a positive result from a rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) assay. * 4\. At the time of HHC randomization, the interval from the onset of the index participant's initial influenza symptoms to informed consent must be ≤48 hours. Symptom onset is defined as: first axillary temperature ≥37.5°C, or the presence of at least one other influenza symptom. * 5\. The index participant must not have used any anti-influenza antiviral medications (including traditional Chinese medicines or Western medicines) since symptom onset, and must be willing to receive oseltamivir phosphate treatment after signing informed consent form. Exclusion Criteria: * 1\. Participants who are diagnosed with bacterial or other non-influenza virus infections at screening requiring systemic antibacterial or antiviral treatment; * 2\. Participants with suspected hypersensitivity to the active ingredients or excipients of oseltamivir phosphate oral suspension/capsules. Household contact: Inclusion Criteria: * 1\. Aged ≥2 years at the time of randomization, with no gender restriction; * 2\. Has been living in the same household with the index participant for at least 48 hours at the time of randomization; * 3\. Is able to reside with the index participant from screening/randomization through Day 10 (must live in the same household with the index participant for at least 7 days); * 4\. Tests negative by rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR); * 5\. Meets all of the following criteria and is judged by the investigator to have no influenza virus infection: 1. Axillary temperature \<37°C at screening; 2. No influenza-related symptoms at screening (such as nasal congestion, sore throat, cough, myalgia or arthralgia, fatigue, headache, chills/sweating, or other influenza symptoms assessed by the investigator); * 6\. The HHC is ≥18 years of age, or the HHC is \<18 years of age and together with their parent(s)/legal guardian(s) understands and voluntarily signs the informed consent form (ICF), and agrees to comply with all study procedures, including completion of diary cards (the guardian may assist in assessment/completion). * 7\. The HHC must sign the informed consent form (ICF) within 24 hours after the index participant signs the ICF; * 8\. The HHC and their partner must agree to practice complete abstinence or use effective contraceptive measures from screening through 3 months after the end of study drug administration. Exclusion Criteria: * 1\. Participants with suspected hypersensitivity to the active pharmaceutical ingredients or excipients of the investigational product; * 2\. Participants whose household contacts or other family members (excluding the index participant) have been diagnosed with influenza within 3 months before randomization; * 3\. Participants who have been cohabiting with other family members exhibiting influenza-like symptoms (axillary temperature ≥37.5°C, nasal congestion, sore throat, cough, myalgia/arthralgia, fatigue, headache, chills/sweating, or other influenza symptoms as assessed by the investigator) other than on the screening day; * 4\. Participants requiring systemic (oral or injectable) or intranasal antipyretic/analgesic agents, corticosteroids, or immunosuppressants (those using topical preparations are allowed); * 5\. Participants who have received an influenza vaccine within 6 months prior to screening; * 6\. Participants who have taken anti-influenza Chinese or Western medications within 30 days prior to screening, including but not limited to neuraminidase inhibitors, hemagglutinin inhibitors, M2 ion channel blockers, cap-dependent endonuclease (CEN) inhibitors, and heat-clearing/detoxifying Chinese herbal medicines, such as oseltamivir, zanamivir, peramivir, laninamivir, umifenovir, favipiravir, rimantadine, amantadine, arbidol, nitazoxanide, baloxavir, Lianhua Qingwen capsules/granules, Jinhua Qinggan granules\*, etc. * 7\. Participants with active infection or requiring systemic anti-infective treatment at screening (topical therapy for mild skin infections is allowed). * 8\. Participants with other respiratory viral infections. * 9\. Participants with difficulty swallowing study medication or a history of gastrointestinal disorders that may significantly impair drug absorption, including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, or post-gastrectomy. * 10\. Participants with severe underlying comorbidities, defined as Grade 3 or higher per the Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0. * 11\. Immunocompromised participants, including those with malignancies, history of organ or bone marrow transplantation, HIV infection, or use of immunosuppressants within the previous 3 months. * 12\. HHCs requiring long-term use of aspirin- or salicylate-containing products, defined as daily regular use for more than 14 consecutive days. * 13\. Participants with suspected or confirmed alcohol abuse (defined as weekly consumption of \>14 units of alcohol; 1 unit = 360 mL beer, 45 mL of 40% spirits, or 150 mL of 12% wine) or history of drug abuse. * 14\. Participants who have participated in another interventional clinical trial of a drug or medical device within 30 days before screening. * 15\. Women who have a positive pregnancy test result or are currently lactating. * 16\. Participants with any other conditions that, in the judgment of the investigator, would preclude enrollment in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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China Japan friendship hospital
Beijing, Beijing Municipality, 100029, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.