Natural History of Coronavirus Disease (COVID-19) in Systemic Autoimmune Diseases

- 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:

1. Stated willingness to comply with all study procedures and availability for the
duration of the study

2. Male or female age greater than or equal to 15 years old with no upper age limit.

3. Ability of subject to understand and the willingness to sign a written informed
consent and/or assent document.

4. 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.

5. 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).

6. 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.

7. 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)

8. 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:

1. Pregnant and lactating subjects will be excluded because pregnancy and lactation
modify immune responses and may interfere with correlations.

2. 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.

3. Concomitant medical, surgical or other conditions for which inadequate facilities are
available to support their care at NIH.

4. Inability or unwillingness to comply with follow up requirements (e.g. distance,
social, physical limitations).

5. 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)

6. Unwilling to participate in research studies or to provide research samples or data

7. Exclusion criteria for the (optional) vascular studies:

-Healthy volunteers with known history of coronary artery disease, peripheral vascular
disease or atherosclerosis.

8. Exclusion criteria for the (optional) FDGPET/CT scan:

-Individuals younger than 18 years old will be excluded given the radiation exposure

9. Subjects with SAD and Healthy volunteers younger than 18 years old will be excluded
from chest x-rays unless clinically indicated.