TreatResp: adaptive study of breathing infections therapies for community care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

TreatResp is a phase 3, double-blind, individually randomized, multi-centre adaptive platform trial evaluating therapeutics for respiratory infections in non-hospitalized adults. Participants are assigned to either usual care or a study therapy chosen by a dedicated therapeutic committee, with time to recovery as the primary outcome. Secondary outcomes include ED visits, hospitalizations, death within 28 days, symptom progression, quality of life, and cost-effectiveness. The study uses an adaptive platform design to test multiple treatments efficiently and can respond to evolving pathogen landscapes. Baloxavir is among the interventions evaluated against placebo, with recruitment leveraging primary care and emergency department networks.

Why it matters

Who can join: the full rules

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

Where it's running

• Unity Health Toronto
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Andrew Pinto, MD — Unity Health Toronto
• Study coordinator: Upstream Lab Upstream Lab
• Email: Upstreamlab@unityhealth.to
• Phone: 4168646060

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.