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 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT05040893
Eligibility Criteria:
Inclusion Criteria:
1. Participant has English language fluency (approximately grade 8-10 reading level) and is able to provide informed consent.
2. Participant is an adult (aged ≥ 18 years).
3. Confirmed diagnosis of COVID-19 via a positive nasopharyngeal or throat swab within the past 12 months.
4. Persistent symptoms lasting ≥12 weeks since the first positive test, including dyspnea (new or increased from baseline as measured by modified Medical Research Council (mMRC) score ≥1).
5. Normal oxygen saturation (greater than 90%) by pulse oximetry at rest on room air.
6. Participant owns a smart phone, tablet, or computer, and has or is willing to create an email address (for links to REDCap and Zoom).
Exclusion Criteria:
1. Abnormal pulmonary function testing (FEV1/FVC ratio \<70, total lung capacity \<80% predicted, or diffusing capacity \<70% predicted).
2. Pre-existing diagnosis chronic lung disease (Interstitial lung disease, COPD, bronchiectasis, or moderate to severe asthma).
3. Pulmonary embolism.
4. Parenchymal abnormalities on chest radiograph, deemed clinically significant by the pulmonologist.
5. Acute or chronic cardiac disease by medical history (myocardial infarction, myocarditis, cardiomyopathy, arrhythmia, moderate or severe valve disease, ventricular dysfunction).
6. Syncope at rest or exertion (which could indicate clinically significant cardiac disease).
7. Pre-existing diagnosis of a post-viral fatigue syndrome, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) or fibromyalgia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05040893
Study Brief:
Protocol Section:
NCT05040893