Natural History of Coronavirus Disease (COVID-19) in Systemic Autoimmune Diseases
Completed
Conditions studied: Systemic Autoimmune Diseases
In brief
Background: Viral infections such as COVID-19 may lead to flare-ups in people with systemic autoimmune diseases (SAD). These infections may also change the function of their immune system and/or cause problems with their blood vessels. Researchers want to learn how people with SAD respond to treatments or vaccines for COVID-19. Objective: To understand how COVID-19 affects inflammation, the immune system, and blood vessels in adults and children with autoimmune diseases. Eligibility: People ages 15 and older who have been diagnosed with an autoimmune disease or are a healthy volunteer Design: Participants will have a screening visit. This will include: Medical history and physical exam EKG Chest x-ray COVID-19 test. A swab will be put in the participant s nose or the back of their mouth. Blood and urine tests Participants will be placed into 1 of 4 groups: 1. Those with previously documented COVID-19 infection or COVID vaccination 2. Those with a recently known COVID-19 exposure or vaccination 3. Those with no known COVID-19 exposure or vaccination 4. Those who developed an acute COVID-19 infection Depending on their group, participants will have 1 to 5 more visits. These will occur over 12 to 18 months. Visits may include: FDG PET/CT scan. Participants will lie in a doughnut-shaped machine. The machine creates pictures of the body. For the scan, they will have a radioactive substance injected into their arm through an IV. Kidney function tests Non-invasive vascular studies test. These tests are similar to what it feels like to have blood pressure checked.
Key facts
- Study ID
- NCT04690816
- Run by
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- People needed
- 293
- Starts
- 2021-02-11
- Expected to finish
- 2024-12-18
- Last updated by the study team
- 2026-03-30
Who can join
Age: 15 and older. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnant and lactating subjects will be excluded because pregnancy and lactation modify immune responses and may interfere with correlations.
- Concomitant medical problems which would confound the interpretation of studies gathered by this protocol. Included in this is the presence of HIV in the blood, active malignancies, or other significant medical conditions that may interferes with interpretation of studies.
- Concomitant medical, surgical or other conditions for which inadequate facilities are available to support their care at NIH.
- Inability or unwillingness to comply with follow up requirements (e.g. distance, social, physical limitations).
- Any comorbidity of medical or psychological/psychiatric condition or treatment, that in the opinion of the Principal Investigator, would exclude the subjects from the research studies (e.g. Patient requiring urgent and/or acute medical care, surgical or other procedures)
- Unwilling to participate in research studies or to provide research samples or data
- Exclusion criteria for the (optional) vascular studies:
- Healthy volunteers with known history of coronary artery disease, peripheral vascular disease or atherosclerosis.
- Exclusion criteria for the (optional) FDGPET/CT scan:
- Individuals younger than 18 years old will be excluded given the radiation exposure
- Subjects with SAD and Healthy volunteers younger than 18 years old will be excluded from chest x-rays unless clinically indicated.
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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