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

NCT04690816 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 293

Last updated 2026-03-30

No results posted yet for this 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.

Conditions

  • Systemic Autoimmune Diseases

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    lead NIH

Principal Investigators

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

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-11
Primary Completion
2024-12-18
Completion
2024-12-18

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04690816 on ClinicalTrials.gov