NCT07314905

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

Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DRUG	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.
DRUG	Placebo Control	Matching placebo for Baloxavir

Timeline

• Start date: 2026-01-02
• Primary completion: 2027-03-31
• Completion: 2027-04-24
• First posted: 2026-01-02
• Last updated: 2026-01-02

Locations

1 site across 1 country: Canada