TreatResp is a double-blind, individually randomized, multi-centre adaptive platformtrial. TreatResp aims to establish an adaptive platform trial aimed at evaluating theclinical- and cost-effectiveness, practical challenges, and outcomes of therapeutics forrespiratory pathogens in non-hospitalized patients. Participants will be randomized toreceive usual care (i.e., supportive care and symptom relief) or a study therapeutic,which will be determined by the TreatResp Therapeutics Committee. The primary outcomesbeing evaluated is time to recovery.
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.
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
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
Unity Health Toronto
Toronto, Ontario, Canada
Investigator: Benita Hoseeini, Phd
Contact: 416-864-6060
Benita.Hosseini@unityhealth.to
Investigator: Andrew Pinto, MD
Upstream Lab Upstream Lab
4168646060 - 76148
Upstreamlab@unityhealth.to
TreatResp Study team
TreatResp@unityhealth.to
Andrew Pinto, MD, Principal Investigator
Unity Health Toronto