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 @ 7:15 PM
Ignite Modification Date:
2025-12-24 @ 7:15 PM
NCT ID:
NCT05704803
Eligibility Criteria:
All Participants must meet ALL of the following:
1. ≥ 2 years of age. Subjects ages 2 ≤ x ≤ 17 will provide assent in addition to parent / legal guardian's consent.
2. Able to read and write in English and/or Spanish (subjects or guardians)
3. Willing and able to provide informed consent (subject or Legally authorized Representative (LAR)). Subjects unable to consent will provide assent in addition to LAR consent.
Symptomatic Participants must meet BOTH of the following:
1. Have at least one of the following symptoms the day of the test:
1. Fever
2. Cough
3. Shortness of Breath
4. Difficulty Breathing
5. Muscle Pain
6. Headache
7. Sore Throat
8. Chills
9. New loss of taste or smell
10. Congestion
11. Runny nose
2. Onset of symptoms occurred within the past 7 calendar days.
Asymptomatic Participants must meet BOTH of the following:
1. Not experiencing any of the following symptoms at the time of specimen collection and testing: fever, cough, shortness of breath or difficulty breathing, new loss of taste or smell, muscle or body aches, headache, sore throat, congestion or runny nose, nausea or vomiting or diarrhea.
2. Exposed to known COVID-19 positive individuals or are suspected to have had COVID-19 over the past 7 calendar days.
Exclusion Criteria:
Participants must not meet ANY of the following:
1. Eating or drinking 30 minutes prior, or smoking 60 minutes prior to specimen collection.
2. Unable to tolerate sample collection, or has contraindications to collection such as nasal bleeding, ulcers, or surgery within the past 3 months.
3. Underwent a nasal wash / aspirate as part of standard of care \< 24 hours prior to the study start.
4. Currently receiving or has received within the past 30 days of the study visit an experimental drug, biologic, or device including treatment or therapy.
5. Previously participated in this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT05704803
Study Brief:
Protocol Section:
NCT05704803