Status:
COMPLETED
Natural History of Coronavirus Disease (COVID-19) in Systemic Autoimmune Diseases
Lead Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Systemic Autoimmune Diseases
Eligibility:
All Genders
15+ years
Brief Summary
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 caus...
Detailed Description
Study Description: This is an observational study to characterize how COVID-19 modulates systemic inflammation, autoimmune features and vasculopathy in adult and pediatric patients with a prior diagn...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria as per respective group:
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female age greater than or equal to 15 years old with no upper age limit.
- Ability of subject to understand and the willingness to sign a written informed consent and/or assent document.
- For Healthy Volunteers Group:
- Age greater than or equal to 15 with no upper age limit.
- No history of autoimmune diseases and in good general health as evidenced by medical history.
- For symptomatic COVID-19 group must have laboratory evidence (positive PCR for SARS-COV-2 or other test developed after this proposal gets approved and is available through the Clinical Center) and one of the signs and symptoms associated with COVID-19 infection (e.g. fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea).
- For post COVID-19 study visits must have laboratory evidence (e.g. positive PCR for SARS- COV-2, antibody against SARS-COV-2 or other test developed after this proposal gets approved) of current or prior exposure to COVID-19. Alternatively, patients should have documented evidence of having received one of the SARS-COV-2 vaccines that may become available during the study.
- For subjects with known COVID exposure, they must fulfill one of the following criteria:
- A minimum of 28 days has passed since the initial positive test date AND B. Resolution of fever was greater than or equal to7 days ago (without the use of fever-reducing medications) AND C. Resolution of respiratory symptoms was greater than or equal to7 days ago, OR
- A minimum of 10 days has passed since the initial positive test AND B. A minimum of 2 consecutive oropharyngeal swabs OR 2 consecutive nasopharyngeal swabs or Mid-turbinate Swabs or 2 saliva testing collected greater than or equal to 24 hours apart that are negative for SARS CoV-2 PCR A positive PCR requires restarting the series of swabs (wait 5 days to retest)
- Specific Inclusion Criteria for Systemic Autoimmunity Diseases Group:
- Age greater than or equal to 15 years with no upper age limit
- Systemic lupus erythematosus (SLE): Meets at least 4 of 11 modified American College of Rheumatology (ACR) (1997) Revised Criteria for the Classification of Systemic Lupus Erythematosus or Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for systemic lupus erythematosus.
- Anti-neutrophil cytoplasmic antibody associated vasculitis (AAV): Meet Revised 1990 ACR criteria for Granulomatosis with polyangiitis (GPA) or the 2012 Chapel Hill Nomenclature for microscopic polyangiitis (MPA).
- Idiopathic inflammatory myopathies (IIM):Meets the 2017 EULAR/ACR Classification Criteria for Adult and Juvenile idiopathic inflammatory myopathies and their major subgroups.
- Primary Sjogren's syndrome (SS): Meets 2016 ACR criteria.
- Progressive systemic sclerosis (PSS): ACR/EULAR 2013 Classification criteria.
- Immunologically mediated kidney diseases (IKD): Based on results from kidney biopsy consistent with immunologically mediated nephrotic syndrome and/or glomerulonephritis
- Rheumatoid arthritis (RA): Meet the 2010 ACR/EULAR Classification Criteria.
- Systemic autoimmunity syndrome not otherwise specified (SA-NOS): Patients not fulfilling criteria for a specific systemic autoimmune disease but with evidence of autoantibodies and clinical features suggestive of a systemic autoimmune disorder.
- EXCLUSION CRITERIA:
- 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.
Exclusion
Key Trial Info
Start Date :
February 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 18 2024
Estimated Enrollment :
293 Patients enrolled
Trial Details
Trial ID
NCT04690816
Start Date
February 11 2021
End Date
December 18 2024
Last Update
May 23 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892