Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07314905
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07314905
Study Brief:
Protocol Section:
NCT07314905