NCT07314905 Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp)
| NCT ID | NCT07314905 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Unity Health Toronto |
| Condition | Influenza A |
| Study Type | INTERVENTIONAL |
| Enrollment | 264 participants |
| Start Date | 2026-04-29 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 264 participants in total. It began in 2026-04-29 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Andrew Pinto, MD
PRINCIPAL INVESTIGATOR
Unity Health Toronto
Frequently Asked Questions
Who can join the NCT07314905 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Influenza A. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07314905 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 264 participants.
Is NCT07314905 currently recruiting?
Yes, NCT07314905 is actively recruiting participants. Contact the research team at Upstreamlab@unityhealth.to for enrollment information.
Where is the NCT07314905 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07314905 clinical trial?
NCT07314905 is sponsored by Unity Health Toronto. The principal investigator is Andrew Pinto, MD at Unity Health Toronto. The trial plans to enroll 264 participants.