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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Health Canada | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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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:
Exclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Upstream Lab Upstream Lab | Contact | 4168646060 | 76148 | Upstreamlab@unityhealth.to |
| TreatResp Study team | Contact | TreatResp@unityhealth.to |
| Name | Affiliation | Role |
|---|---|---|
| Andrew Pinto, MD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unity Health Toronto | Toronto | Ontario | Canada |
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| Label | URL |
|---|---|
| study website | View source |
| Lab website - Project page | View source |
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Our team is dedicated to making data accessible to researchers upon request.
End of study (TBD) and upon request until 15years after study completion.
Study PI
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D007251 | Influenza, Human |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D007239 | Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C000628402 | baloxavir |
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Research study staff (Research Assistants, PI, Statistician, QI, Co-PI, Manager and Coordinators)
|
| Placebo Control | Drug | Matching placebo for Baloxavir |
|
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 |
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |