๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 \>37.5ยฐC/ 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 โฅ30 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