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Could a single pill shorten the flu? new trial aims to find out

NCT ID NCT07314905

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 264 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Unity Health Toronto

    RECRUITING

    Toronto, Ontario, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.