Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnity Health Toronto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
rhinitis
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Baloxavir
DrugThis 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.
Placebo Control
DrugMatching placebo for Baloxavir
Treatment groups
264 Participants
are divided into 2 treatment groupsGroup A: Acute Influenza A/B - Matched placebo for BaloxavirPlacebo comparator 1 intervention
Group B: Acute Influenza A/B - BaloxavirExperimental treatment 1 intervention
Trial outcomes
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)
Time frame
Day 1 to Day 28Secondary outcomes
1
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.
Time frame
Day 1 to Day 282
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.
Time frame
Day 1 to Day 283
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.
Time frame
Day 1 to Day 284
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."
Time frame
Day 1 to Day 28Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Unity Health Toronto
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Health Canada
Collaborator
Source ClinicalTrials.gov