Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp)
Trial statusNot yet recruiting
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
Qualifiers
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
Treatments tested in this trial
- Baloxavir
- Placebo Control
Treatment groups
264 Participants
are divided into 2 treatment groupsSponsors and collaborators
Unity Health Toronto
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Health Canada
Collaborator
Source ClinicalTrials.gov