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Completed No phase listed Observational Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT04690816

Public ClinicalTrials.gov record NCT04690816. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 10, 2026, 12:36 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04690816
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Enrollment
293 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
15 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 11, 2021 (Actual)
Primary completion
Dec 18, 2024 (Actual)
Completion
Dec 18, 2024 (Actual)
Last update posted
Sep 22, 2026

2021 – 2024

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
National Institutes of Health Clinical Center Bethesda Maryland 20892 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04690816, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 22, 2026 · Synced Oct 10, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04690816 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →