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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT05107258
Eligibility Criteria:
Inclusion Criteria:
1. Subjects must present with 1 or more signs or symptoms of COVID-19 infection\*.
2. Subjects must have experienced symptom onset within the previous 10 days.
3. Subject or Subject's legally authorized representative (LAR) is willing and able to provide informed consent. Adult subjects unable to consent will provide assent in addition to LAR's consent.
4. Subject is ≥ 6 years of age. Subjects 6 ≥ x ≤ 17 will provide assent in addition to parent/legal guardian's consent.
Exclusion Criteria:
1. Individual is not able to tolerate sample collection.
2. The subject has been positive for SARS-CoV-2 previously.
3. The subject underwent a nasal wash/aspirate as part of standard of care \<24 hours prior to the study visit.
4. The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
5. The subject has previously participated in this research study.
* Symptoms may appear 2-10 days after exposure and may include one or more of the following: Fever, Cough, Shortness of Breath, Difficulty Breathing, Muscle Pain, Headache, Sore Throat, Chills, New Loss of Taste or Smell, Congestion, Runny Nose, Diarrhea, Nausea or vomiting.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT05107258
Study Brief:
Protocol Section:
NCT05107258