Recruiting
Phase 3

TreatResp

Sponsor:

Unity Health Toronto

Code:

NCT07314905

Conditions

Influenza A

Influenza B

SAR-CoV-2

Acute Respiratory Infections (ARIs)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Baloxavir

Placebo Control

Study Details

Brief 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. 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.

Conditions

Influenza A

Influenza B

SAR-CoV-2

Acute Respiratory Infections (ARIs)

Study ID

NCT07314905

Start date

Apr 29, 2026

Status verified date

Aug, 2026

Completion date

Apr 24, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

264 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Acute Influenza A/B - Matched placebo for Baloxavir

Usual Care (i.e., supportive care and symptom relief). Matching control placebo for Baloxavir - a single matching dose.

experimental: Acute Influenza A/B - Baloxavir

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.

Interventions

Baloxavir

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 Control

Matching placebo for Baloxavir

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 ]

Central Contacts and Locations

Central contacts

Upstream Lab Upstream Lab

4168646060Upstreamlab@unityhealth.to

TreatResp Study team

TreatResp@unityhealth.to

Locations

Unity Health Toronto

Recruiting

Toronto, Ontario, Canada

Contacts

Benita Hoseeini, Phd

416-864-6060Benita.Hosseini@unityhealth.to

Kawsika Sivayoganathan, H.BSc

kawsika.sivayoganathan@unityhealth.to

Principal Investigator:

Andrew Pinto, MD

More Information

Sponsor

Unity Health Toronto

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • COVID-19
  • SARS-CoV-2
  • Influenza A
  • Influenza B
  • Influenza
  • Respiratory pathogens
  • Respiratory infections
  • Adaptative Platform Trials (APT)
  • acute respiratory infections (ARIs)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2026-08-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.