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:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT04565067
Eligibility Criteria:
* INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Ability of subject to understand the study and stated willingness to comply with all study procedures and availability for the duration of the study.
2. Male or female, aged 18 years or older.
3. Able to speak and read English.
4. Willingness and ability to come to the NIA Clinical Research Unit at MedStar Harbor Hospital in Baltimore for study procedures.
5. Proof of positive SARS-CoV-2 testing exhibiting no current clinical symptoms.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
1. Unable to verify identification of volunteer by state issued ID card, driver's license, or military ID. Participants earning greater than $600.00/year are issued a 1099 form, therefore, positive identification is required.
2. Unable to provide informed consent
3. Current use of steroids, immunosuppressive medications, radiation therapy, or chemotherapy medications.
4. Pregnancy.
5. Received immunization therapy for COVID-19 or have received a COVID-19 vaccination prior to Visit 1.
In addition, eligible participants may not be immediately able to participate in the study but might be eligible at a later date. These include:
1. Symptoms of a viral infection on visit 1 (defer until resolved).
2. Medication: Volunteers taking the following medications would be deferred for 2 weeks after course has been completed and volunteer is feeling well: Antibiotics, antifungals, antimalarials, antvirals.
3. Temporary steroids (tapers): Deferred for 72 hours after symptoms are resolved and prescription is completed if taken orally, intravenously, or intramuscular. No deferral if taken intranasal, inhaled, or for joint injection.
4. Infection or Fever: Deferred until 2 weeks after antibiotics are completed and /or volunteer is feeling well.
5. We wish to only select recovered confirmed COVID-19 patients. Therefore, those who may have a household member (co-habitant) who is newly diagnosed with COVID-19 or who has symptoms will be deferred for 14 days.
6. Treatment with another investigational drug or other intervention within 14 days of visit 1 per the discretion of the Principal Investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04565067
Study Brief:
Protocol Section:
NCT04565067