Could a single pill shorten the flu? new trial aims to find out
NCT ID NCT07314905
First seen Jun 25, 2026 · Last updated Aug 19, 2026 · Updated 3 times
Summary
This phase 3 trial tests whether a single dose of baloxavir helps non-hospitalized adults with mild-to-moderate influenza recover faster compared to a placebo. About 264 participants will be enrolled within 5 days of symptoms and tracked until they feel fully recovered. The study is part of a larger platform trial that can adapt to test other respiratory treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Baloxavir (a single-dose antiviral pill)
- What this could lead to
- If it works, this could provide a simple, one-dose treatment to help people recover faster from the flu at home.
- What could go wrong
- This is an early-stage sub-study within a larger platform trial, so results are uncertain. Baloxavir may not speed recovery more than placebo, and side effects are possible.
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 264 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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.
Inclusion Criteria: * 18 years or older * A positive test (PCR or RAT) for one of the pathogens included in the trial's domains (influenza A/B, or other future specified respiratory pathogens), * Enrolled within 5 days of symptoms onset. However, this window may vary depending on the domain or specific interventions within each domain (for example 72 hours for Baloxavir). * At least two symptoms commonly associated with respiratory infections, including: * rhinitis * cough * wheezing * sore throat * nasal congestion * shortness of breath * fatigue * rapid breathing * excessive mucus production * loss of smell or taste * hemoptysis * trouble sleeping or insomnia due to breathing difficulties * fever (defined for purposes of this study as \>37.5°C/ 41). Exclusion Criteria: * Admitted to hospital or in an ED for more than 24 hours * Previously randomized to TreatResp within the past 12 months * Currently participating in a clinical trial of a therapeutic agent for acute respiratory pathogen infection that is not/suspected not compatible with the study therapeutics * Already taking a study therapeutic or contraindication to a study therapeutic * Inability for participant or caregiver to provide informed consent. Additional eligibility criteria will be applied based on the intervention assigned. For instance, if a participant is randomized to an antiviral treatment, they must not have contraindications specific to that antiviral. This ensures that each treatment is evaluated in a population for whom it is most appropriate and safe. Baloxavir exclusion: * Has a known or suspected pregnancy * Is breastfeeding * Is of childbearing potential and is not willing to use a highly effective contraceptive * Has advanced chronic kidney disease (CKD stage 3: eGFR ≥30 to \<60 mL/min, and severe renal impairment (eGFR \<30 ml/min, CKD stage 4-5) * Has severe hepatic impairment, or requires a live viral vaccine within the next seven days * Has a significant impaired immunity (e.g., due to long-term oral steroids, chemotherapy, or an immune disorder) * Requires immediate antiviral treatment or hospitalization as per the clinician's judgment * Is allergic to trial medications * Is scheduled for elective surgery or procedures requiring general anesthesia within the next two weeks * Is co-infected with viruses of interest * Received a live viral vaccine within the last 14 days
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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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Unity Health Toronto
RECRUITINGToronto, Ontario, Canada
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