Official Title
The Natural History of Coronavirus Disease (COVID-19) in Systemic Autoimmune Diseases; An Observational Prospective Study
Brief Summary

Background:Viral infections such as COVID-19 may lead to flare-ups in people with systemicautoimmune diseases (SAD). These infections may also change the function of their immunesystem and/or cause problems with their blood vessels. Researchers want to learn howpeople with SAD respond to treatments or vaccines for COVID-19.Objective:To understand how COVID-19 affects inflammation, the immune system, and blood vessels inadults and children with autoimmune diseases.Eligibility:People ages 15 and older who have been diagnosed with an autoimmune disease or are ahealthy volunteerDesign:Participants will have a screening visit. This will include:Medical history and physical examEKGChest x-rayCOVID-19 test. A swab will be put in the participant s nose or the back of their mouth.Blood and urine testsParticipants 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 infectionDepending on their group, participants will have 1 to 5 more visits. These will occurover 12 to 18 months. Visits may include:FDG PET/CT scan. Participants will lie in a doughnut-shaped machine. The machine createspictures of the body. For the scan, they will have a radioactive substance injected intotheir arm through an IV.Kidney function testsNon-invasive vascular studies test. These tests are similar to what it feels like to haveblood pressure checked.

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 diagnosis of systemic autoimmunity, and their overall outcomes including response
to potential antiviral treatments or vaccines.

Objectives:

Primary Objective: Characterize how COVID-19 modulates systemic inflammation,
autoimmunity features, organ damage and vasculopathy in adult and pediatric patients with
a diagnosis of systemic autoimmunity. Characterize how exposure to a COVID vaccine
modulates systemic inflammation, autoimmunity features and vasculopathy in adult and
pediatric patients with a diagnosis of systemic autoimmunity. Assess how subjects with
systemic autoimmunity respond to COVID-19 regarding antiviral and/or proinflammatory
responses and overall outcomes

Secondary Objectives: Understand prevalence and severity of COVID-19 in individuals with
autoimmune diseases, and the variables that associate/predict these responses.

Endpoints:

Primary Endpoint: Immune dysregulation and vasculopathy modulation following COVID-19.

Secondary Endpoints: Immunologic and clinical response to potential antiviral/immune
modulator treatments and/or vaccines that are used during COVID-19 for clinical purposes.
Overall outcome following exposure to COVID-19 and/or COVID vaccine (response to virus,
status of rheumatologic disease)

Recruiting
Systemic Autoimmune Diseases
Eligibility Criteria

- 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.

Eligibility Gender
All
Eligibility Age
Minimum: 15 Years ~ Maximum: N/A
Countries
United States
Locations

National Institutes of Health Clinical Center
Bethesda, Maryland, United States

Investigator: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Contact: 800-411-1222
prpl@cc.nih.gov

Contacts

Mariana J Kaplan, M.D.
(301) 496-0517
mariana.kaplan@nih.gov

Mariana J Kaplan, M.D., Principal Investigator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NCT Number
Keywords
COVID-19 Study
Natural History of Coronavirus Disease (COVID-19) in Systemic Autoimmune Disease
An Observational Prospective Study for COVID-19
Natural History
MeSH Terms
COVID-19
Coronavirus Infections
Autoimmune Diseases