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Influenza APhase 3TreatRespNCT07314905

Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp)

A Phase 3 study testing Baloxavir in people with Influenza A and Influenza B, run by Unity Health Toronto at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

TreatResp is a double-blind, individually randomized, multi-centre adaptive platform trial. TreatResp aims to establish an adaptive platform trial aimed at evaluating the clinical- and cost-effectiveness, practical challenges, and outcomes of therapeutics for respiratory pathogens in non-hospitalized patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Influenza A, Influenza B, SAR-CoV-2
What is being tested?
Baloxavir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
264 participants
Where
1 siteCanada
Study dates
29 Apr 2026to 24 Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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).

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Upstream Lab Upstream Lab contact

4168646060 ext. 76148

Upstreamlab@unityhealth.to

TreatResp Study team contact

TreatResp@unityhealth.to

Canada1 site, 1 recruiting

  • Unity Health Toronto

    Toronto, Ontario

    Benita Hoseeini, Phd, 416-864-6060, Benita.Hosseini@unityhealth.to

    Kawsika Sivayoganathan, H.BSc, kawsika.sivayoganathan@unityhealth.to

    Recruiting

Other trials in Canada

About this study

Official title: Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings

TreatResp is a double-blind, individually randomized, multi-centre adaptive platform trial. TreatResp aims to establish an adaptive platform trial aimed at evaluating the clinical- and cost-effectiveness, practical challenges, and outcomes of therapeutics for respiratory pathogens in non-hospitalized patients. Participants will be randomized to receive usual care (i.e., supportive care and symptom relief) or a study therapeutic, which will be determined by the TreatResp Therapeutics Committee. The primary outcomes being evaluated is time to recovery.

Read the detailed description

Effective and affordable therapeutics for respiratory pathogens that can be used easily in community settings are needed to accelerate recovery, prevent hospitalizations and deaths. The Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp) will evaluate the clinical effectiveness and cost-effectiveness of therapeutics for respiratory pathogens in non-hospitalized patients. Adaptive platform trials (APTs) are designed to compare multiple therapies in an efficient manner and allow us to respond to the dynamic nature of pandemics. Therapeutics to be evaluated will be identified through a transparent TreatResp Therapeutics Committee. The primary outcome is time to recovery (defined as the first instance that a participant report feeling fully recovered), and key secondary outcomes include all-cause emergency department (ED) visit and/or hospitalization and/or death at 28 days, time to sustained resolution, time to progression of signs or symptoms, symptom severity, quality of life, and cost-effectiveness of each therapeutic. TreatResp leverages our CBRF funded Pandemic Preparedness Engaging Primary Care and Emergency Departments (PREPARED) initiative to recruit participants to the study.

Being tested
Baloxavir, Placebo Control
Keywords
COVID-19, SARS-CoV-2, Influenza A, Influenza B, Influenza, Respiratory pathogens, Respiratory infections, Adaptative Platform Trials (APT), acute respiratory infections (ARIs)
Medical subject headings
COVID-19, Influenza, Human, Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BaloxavirDrug

    This is a sub-protocol within the TreatResp adaptive platform trial to compare the clinical and cost-effectiveness of Baloxavir, a single 40mg or 80 mg tablet based on patient weight, to a matching placebo among non-hospitalized patients with mild to moderate influenza A/B. This sub-protocol is part of the influenza domain within TreatResp.

  • Placebo ControlDrug

    Matching placebo for Baloxavir

Study groups in NCT07314905
Study groupRoleWhat they receive
Acute Influenza A/B - Matched placebo for BaloxavirPlacebo comparatorUsual Care (i.e., supportive care and symptom relief). Matching control placebo for Baloxavir - a single matching dose.
Receives: Drug: Placebo Control
Acute Influenza A/B - BaloxavirExperimentalThe adaptative platform trial will assess therapeutics for influenza A/B in out-patient setting. Interventions include: Baloxavir. Baloxavir dose: if weight <80 kg: one 40 mg dose for 1 day; if weight ≥80kg, one 80 mg dose for one day.
Receives: Drug: Baloxavir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. time to recovery (defined as the first instance that a participant report feeling fully recovered)

    The primary outcome is time to recovery (defined as the first instance that a participant report feeling fully recovered)

    Measured: Day 1 to Day 28

Secondary outcomes (6)

  1. All-cause emergency department (ED) visits

    All-cause emergency department (ED) visits from randomization to 28 days, captured during participant daily diaries and corroborated with administrative data where possible, using administrative data holdings.

    Measured: Day 1 to Day 28

  2. All-cause hospitalization visits

    All-cause hospitalization visits from randomization to 28 days, captured during participant daily diaries and corroborated with administrative data where possible, using administrative data holdings.

    Measured: Day 1 to Day 28

  3. All-cause death

    All-cause death at 28 days from randomization to 28 days, captured during participant daily diaries and corroborated with administrative data where possible, using administrative data holdings.

    Measured: Day 1 to Day 28

  4. Symptom severity obtained through daily diaries questionnaire

    Symptom severity obtained through daily diaries questionnaire using the questions: "How is your general health? where 0 is poor and 5 is excellent and by rating symptoms, if present, as "No symptoms, mild, moderate, severe or very severe."

    Measured: Day 1 to Day 28

  5. Quality of life obtained through the daily dairies using EQ-5D-5L

    Quality of life obtained through the daily dairies using EQ-5D-5L

    Measured: Day 1 to Day 28

  6. Costs and cost/QALY

    Costs and cost/QALY assessed using data from participant daily diaries capturing health care use and treatment, combined with health-related quality of life measures.

    Measured: Day 1 to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2026
  2. Study start29 Apr 2026
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion24 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
264 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07314905
Sponsor's protocol ID
CTO 5178
Acronym
TreatResp
Status last verified
Aug 2026
First submitted
1 Oct 2025
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Our team is dedicated to making data accessible to researchers upon request.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Baloxavir in people with Influenza A and Influenza B, run by Unity Health Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Upstream Lab Upstream Lab (4168646060 ext. 76148, Upstreamlab@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

time to recovery (defined as the first instance that a participant report feeling fully recovered) (time frame: Day 1 to Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07314905.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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