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

Last updated: May 22, 2025
Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Overall Status: Completed

Phase

N/A

Condition

Covid-19

Collagen Vascular Diseases

Connective Tissue Diseases

Treatment

N/A

Clinical Study ID

NCT04690816
10000207
000207-AR
  • Ages > 15
  • All Genders
  • Accepts Healthy Volunteers

Study 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 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.

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:

  1. Stated willingness to comply with all study procedures and availability for theduration 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 informedconsent 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 bymedical history.

  1. For symptomatic COVID-19 group must have laboratory evidence (positive PCR forSARS-COV-2 or other test developed after this proposal gets approved and isavailable through the Clinical Center) and one of the signs and symptoms associatedwith COVID-19 infection (e.g. fever or chills, cough, shortness of breath ordifficulty breathing, fatigue, muscle or body aches, headache, new loss of taste orsmell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea).

  2. For post COVID-19 study visits must have laboratory evidence (e.g. positive PCR forSARS- COV-2, antibody against SARS-COV-2 or other test developed after this proposalgets approved) of current or prior exposure to COVID-19. Alternatively, patientsshould have documented evidence of having received one of the SARS-COV-2 vaccinesthat may become available during the study.

  3. For subjects with known COVID exposure, they must fulfill one of the followingcriteria:

  • 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 offever-reducing medications) AND C. Resolution of respiratory symptoms wasgreater than or equal to7 days ago, OR

  • A minimum of 10 days has passed since the initial positive test AND B. Aminimum of 2 consecutive oropharyngeal swabs OR 2 consecutive nasopharyngealswabs or Mid-turbinate Swabs or 2 saliva testing collected greater than orequal to 24 hours apart that are negative for SARS CoV-2 PCR A positive PCRrequires restarting the series of swabs (wait 5 days to retest)

  1. 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 AmericanCollege of Rheumatology (ACR) (1997) Revised Criteria for the Classification ofSystemic Lupus Erythematosus or Systemic Lupus International CollaboratingClinics (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 ChapelHill Nomenclature for microscopic polyangiitis (MPA).

  • Idiopathic inflammatory myopathies (IIM):Meets the 2017 EULAR/ACRClassification Criteria for Adult and Juvenile idiopathic inflammatorymyopathies 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 kidneybiopsy consistent with immunologically mediated nephrotic syndrome and/orglomerulonephritis

  • Rheumatoid arthritis (RA): Meet the 2010 ACR/EULAR Classification Criteria.

  • Systemic autoimmunity syndrome not otherwise specified (SA-NOS): Patients notfulfilling criteria for a specific systemic autoimmune disease but withevidence of autoantibodies and clinical features suggestive of a systemicautoimmune disorder.

Exclusion

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 lactationmodify immune responses and may interfere with correlations.

  2. Concomitant medical problems which would confound the interpretation of studiesgathered by this protocol. Included in this is the presence of HIV in the blood,active malignancies, or other significant medical conditions that may interfereswith interpretation of studies.

  3. Concomitant medical, surgical or other conditions for which inadequate facilitiesare 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, thatin the opinion of the Principal Investigator, would exclude the subjects from theresearch studies (e.g. Patient requiring urgent and/or acute medical care, surgicalor 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, peripheralvascular disease or atherosclerosis.

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

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

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

Study Design

Total Participants: 293
Study Start date:
February 11, 2021
Estimated Completion Date:
December 18, 2024

Study 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)

Connect with a study center

  • National Institutes of Health Clinical Center

    Bethesda, Maryland 20892
    United States

    Site Not Available

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