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 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT04860869
Eligibility Criteria:
COVID Non-Symptomatic controls (nPASC)
Inclusion criteria
1. Male or female with a history of COVID with diagnosis confirmed by PCR test.
2. Minimum of 6 months since diagnosis of COVID by PCR test.
3. Ages 18 to 80 years.
4. Participant is willing and able to give informed consent for participation in the study.
Exclusion criteria
1. Current COVID infection.
2. Unable to walk unassisted.
3. Significant heart, liver, kidney, blood or respiratory disease as determined by Principal Investigator.
4. Uncontrolled diabetes mellitus.
5. Any history of a recently (12 months) diagnosed cancer other than a skin cancer (excluding melanoma).
6. Current alcohol or drug abuse.
7. History of psychosis.
8. Pregnancy or become pregnant during the trial.
9. Subjects who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.
10. Other medical condition or medication administration deemed exclusionary by the study investigators.
COVID Symptomatic Subjects (PASC)
Inclusion Criteria:
1. Male or female with a history of COVID with diagnosis confirmed by PCR test.
2. Has been seen at UTMB Post COVID clinic.
3. Minimum of 6 months since diagnosis of COVID by PCR test.
4. Ages 18 to 80 years.
5. Score of 3 or higher on any question 1-3 of the Brief Fatigue Inventory (BFI) questionnaire.
6. Participant is willing and able to give informed consent for participation in the study.
Exclusion Criteria:
1. Current COVID infection.
2. Unable to walk unassisted.
3. Significant heart, liver, kidney, blood or respiratory disease.
4. Uncontrolled diabetes mellitus.
5. Any history of a recently (12 months) diagnosed cancer other than a skin cancer (excluding melanoma).
6. Current alcohol or drug abuse.
7. History of psychosis.
8. Pregnancy or become pregnant during the trial.
9. Subjects who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.
10. Other medical condition or medication administration deemed exclusionary by the study investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04860869
Study Brief:
Protocol Section:
NCT04860869