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

NCT ID: NCT07314905

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-02
• Study Completion Date: 2027-04-24

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.

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.

Conditions

Influenza A; Influenza B; SAR-CoV-2; Acute Respiratory Infections (ARIs)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo Control

Intervention Type: DRUG

Matching placebo for Baloxavir

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.

Group Type: EXPERIMENTAL

Baloxavir

Intervention Type: DRUG

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.

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.

Intervention Type: DRUG

Placebo Control

Matching placebo for Baloxavir

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Health Canada

OTHER_GOV

Sponsor Role: collaborator

Responsible Party

Andrew Pinto

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Pinto, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

Unity Health Toronto

Toronto, Ontario, Canada

Countries

Canada

Central Contacts

Upstream Lab Upstream Lab

Role: CONTACT

Upstreamlab@unityhealth.to

4168646060 ext. 76148

TreatResp Study team

Role: CONTACT

TreatResp@unityhealth.to

Facility Contacts

Benita Hoseeini, Phd

Role: primary

Benita.Hosseini@unityhealth.to

416-864-6060

Kawsika Sivayoganathan, H.BSc

Role: backup

kawsika.sivayoganathan@unityhealth.to

Related Links

https://TreatResp.org

study website

https://upstreamlab.org/project/treatresp/

Lab website - Project page

Other Identifiers

CTO 5178

Identifier Type: -

Identifier Source: org_study_id