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 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
NCT ID:
NCT04828668
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 years of age or older who can provide informed consent.
2. Persons who have been diagnosed with COVID-19 and now in post-acute recovery phase.
3. Persons who are in care with access to primary care for post COVID infection or PACS.
4. Ability to read and write in the English language and follow study-related procedures.
5. Ability to have mail/ study drug delivered to an address and/or P.O. Box in the recipient's name.
6. Ability to participate in telemedicine visits/communication.
7. If a woman of childbearing age, willing to use a dual method of contraception (barrier and/or hormonal).
Exclusion Criteria:
1. Active illicit or non-prescribed drug use.
2. Concomitant use of benzodiazepines.
3. Concomitant use of an immune suppressant agent, e.g., prednisone.
4. Documented history and active treatment for seizure disorder.
5. Transaminase elevation.
6. Active autoimmune disorder.
7. Hepatitis C infection (currently on therapy and/or any transaminitis elevation).
8. Hepatitis B infection (currently on therapy and/or any transaminitis elevation).
9. Human Immune Deficiency Virus (HIV-1 or HIV-2) infection that is newly diagnosed or untreated.
10. Any form of mental impairment that will/could hinder safe participation in the study.
11. Pregnancy or breast-feeding.
12. Any condition that in the opinion of the investigator would be harmful or detrimental to the participant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04828668
Study Brief:
Protocol Section:
NCT04828668