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:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT06746259
Eligibility Criteria:
Inclusion Criteria:
* Subject exhibits or reports a new onset measured temperature (oral or tympanic) of greater than or equal to 100.5°F/38°C within 3 days (72 hours) of enrollment or at the visit
* Subject has clinical suspicion for Acute Respiratory Infection and presents with at least one (1) of the following new onset symptoms beginning ≤ 7 days of enrollment: runny nose, nasal congestion, sore throat, cough, hoarse voice or shortness of breath
Exclusion Criteria:
* Subject is unable or unwilling to provide signed, Informed Consent
* Subject is less than 12 years old or over 64 years old
* Subject has a fever that started more than 3 days (\> 72 hours) prior to enrollment
* Subject has symptoms of Acute Respiratory Infection that started \> 7 days of enrollment
* Subject is receiving interferon therapy (e.g. MS, HIV, HBV, HCV) in the last 30 days
* Subject is in an immunocompromised state (e.g. HIV) or taking immunosuppressive or chemotherapeutic medications in the last 30 days (e.g. oral steroids, Methotrexate, Cyclosporine, Antimetabolite chemotherapy, interferon therapy)
* Subject has taken antibiotics or antiviral therapy in the last 14 days
* Subject received a live viral immunization in the last 14 days
* Subject has significant trauma or burns (\> 5% total body surface area or full thickness (3rd°)) in the last 30 days
* Subject has had major surgery (requiring intravenous anesthesia and/or respiratory assistance) in the last 30 days
* Subject has a history of a myocardial infarction or stroke in the last 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
64 Years
Study:
NCT06746259
Study Brief:
Protocol Section:
NCT06746259