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.
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
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.
TreatResp Study team contact
Canada1 site, 1 recruiting
- Recruiting
Unity Health Toronto
Toronto, Ontario
Benita Hoseeini, Phd, 416-864-6060, Benita.Hosseini@unityhealth.to
Kawsika Sivayoganathan, H.BSc, kawsika.sivayoganathan@unityhealth.to
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 group | Role | What they receive |
|---|---|---|
| Acute Influenza A/B - Matched placebo for Baloxavir | Placebo comparator | Usual 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 - Baloxavir | Experimental | The 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.
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)
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
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
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
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
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
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.
- First posted2 Jan 2026
- Study start29 Apr 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion24 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Health Canada
- Responsible party
- Principal investigator, Andrew Pinto, Unity Health Toronto
- Investigators
- Andrew Pinto, MD, Principal investigator, Unity Health Toronto
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.