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 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
NCT ID:
NCT06189066
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-65 years at the time of enrollment
2. Prior diagnosis of COVID-19 by report, PCR, or home kit
3. Symptoms present for 12 or more weeks that are independent prior to SARS-CoV-2 infection including fatigue and one or more of:
1. Myalgia or general aches/pains
2. Joint pain
3. Dizziness/lightheadedness
4. Cognitive dysfunction (brain fog)
Exclusion Criteria:
1. Candidate who is unable or unwilling to postpone taking new medications used for treating Long COVID during the study period
2. Candidate that is currently taking immune modifying medications and unable to maintain stable levels of their immune medication regimen throughout the study period
3. History of intubation secondary to COVID-19
4. ICU admission for COVID-19
5. Pre-existing Lung conditions such as chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), or severe asthma
6. Pregnant
7. History of coronary artery disease (CAD)
8. History of stroke
9. History of severe anemia of hemoglobin less than 8 g/dl
10. Prior history of Lyme disease
11. Prior history cognitive impairment
12. Any non-marijuana drug abuse history within 30 days
13. Current use of an investigational drug
14. History of prior myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS)
15. History of alcohol abuse: greater than 2 drinks a day for men and 1 drink for females
16. Prior history of postural orthostatic tachycardia syndrome (POTS)
17. Chronic fatigue secondary to any condition other than COVID-19.
18. Fibromyalgia
19. History of prior chronic pain
20. History of chronic liver disease such as cirrhosis
21. History of splenic pathology such as spleen infarct/splenomegaly
22. History of splenectomy
23. History of Sickle disease with splenic pathology
24. Taking non-approved treatments for Long COVID
25. Participant does not speak English
26. Participant is an active member of the military (service member) or DoD personnel (including civilian employees)
27. Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06189066
Study Brief:
Protocol Section:
NCT06189066