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

NCT07314905 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: CTO 5178
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

COVID-19; SARS-CoV-2; Influenza A; Influenza B; Influenza; Respiratory pathogens; Respiratory infections; Adaptative Platform Trials (APT); acute respiratory infections (ARIs)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• All-cause emergency department (ED) visits

  Day 1 to Day 28

• All-cause hospitalization visits

  Day 1 to Day 28

• All-cause death

  Day 1 to Day 28

• Symptom severity obtained through daily diaries questionnaire

  Day 1 to Day 28

• Quality of life obtained through the daily dairies using EQ-5D-5L

  Day 1 to Day 28

Study Arms (2)

Acute Influenza A/B - Matched placebo for Baloxavir

PLACEBO COMPARATOR

Usual Care (i.e., supportive care and symptom relief). Matching control placebo for Baloxavir - a single matching dose.

Drug: Placebo Control

Acute Influenza A/B - Baloxavir

EXPERIMENTAL

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

Interventions

Baloxavir 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.

Acute Influenza A/B - Baloxavir

Placebo Control DRUG

Matching placebo for Baloxavir

Acute Influenza A/B - Matched placebo for Baloxavir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Health Canada: collaborator

Study Sites (1)

Unity Health Toronto

Toronto, Ontario, Canada

Location

Related Links

• study website
• Lab website - Project page

MeSH Terms

Conditions

COVID-19; Influenza, Human; Respiratory Tract Infections

Interventions

baloxavir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Study Officials

• Andrew Pinto, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Upstream Lab Upstream Lab

CONTACT

4168646060; Upstreamlab@unityhealth.to

TreatResp Study team

CONTACT

TreatResp@unityhealth.to

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research study staff (Research Assistants, PI, Statistician, QI, Co-PI, Manager and Coordinators)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: January 2, 2026
• Study Start: January 2, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): April 24, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: End of study (TBD) and upon request until 15years after study completion.
• Access Criteria: Study PI

Locations

CA (1)