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

Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Influenza A; Influenza B; Acute Respiratory Infections (ARIs); SAR-CoV-2
• Intervention / Treatment: Drug: Placebo Control; Drug: Baloxavir

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.

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Upstream Lab Upstream Lab; Phone Number: 76148 4168646060; Email: Upstreamlab@unityhealth.to
• Study Contact Backup: Name: TreatResp Study team; Email: TreatResp@unityhealth.to

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Unity Health Toronto
      • Principal Investigator: Andrew Pinto, MD
      • Contact: Benita Hoseeini, Phd; Phone Number: 416-864-6060; Email: Benita.Hosseini@unityhealth.to
      • Contact: Kawsika Sivayoganathan, H.BSc; Email: kawsika.sivayoganathan@unityhealth.to

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Placebo Control; Matching placebo for Baloxavir
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to recovery (defined as the first instance that a participant report feeling fully recovered)	The primary outcome is time to recovery (defined as the first instance that a participant report feeling fully recovered)	Day 1 to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause emergency department (ED) visits	All-cause emergency department (ED) visits from randomization to 28 days, captured during participant daily diaries and corroborated with administrative data where possible, using administrative data holdings.	Day 1 to Day 28
All-cause hospitalization visits	All-cause hospitalization visits from randomization to 28 days, captured during participant daily diaries and corroborated with administrative data where possible, using administrative data holdings.	Day 1 to Day 28
All-cause death	All-cause death at 28 days from randomization to 28 days, captured during participant daily diaries and corroborated with administrative data where possible, using administrative data holdings.	Day 1 to Day 28
Symptom severity obtained through daily diaries questionnaire	Symptom severity obtained through daily diaries questionnaire using the questions: "How is your general health? where 0 is poor and 5 is excellent and by rating symptoms, if present, as "No symptoms, mild, moderate, severe or very severe."	Day 1 to Day 28
Quality of life obtained through the daily dairies using EQ-5D-5L	Quality of life obtained through the daily dairies using EQ-5D-5L	Day 1 to Day 28
Costs and cost/QALY	Costs and cost/QALY assessed using data from participant daily diaries capturing health care use and treatment, combined with health-related quality of life measures.	Day 1 to Day 28

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: Canadian Institutes of Health Research (CIHR); Health Canada
• Investigators: Principal Investigator: Andrew Pinto, MD, Unity Health Toronto

Publications and helpful links

Helpful Links

• study website
• Lab website - Project page

Study record dates

Study Major Dates

• Study Start (Estimated): January 2, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): April 24, 2027

Study Registration Dates

• First Submitted: October 1, 2025
• First Submitted That Met QC Criteria: December 31, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Influenza; COVID-19; Respiratory infections; Influenza A; Influenza B; Respiratory pathogens; Adaptative Platform Trials (APT); acute respiratory infections (ARIs)
• Additional Relevant MeSH Terms: Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Influenza, Human; Respiratory Tract Infections; baloxavir
• Other Study ID Numbers: CTO 5178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Our team is dedicated to making data accessible to researchers upon request.
• IPD Sharing Time Frame: End of study (TBD) and upon request until 15years after study completion.
• IPD Sharing Access Criteria: Study PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No