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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    350
  • sponsor
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Updated on 22 October 2022
Accepts healthy volunteers

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.

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.

Primary Objective:Characterize how COVID-19 modulates systemic inflammation, autoimmunity features, organ damage and vasculopathy in adult and pediatric patients with a previous 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.

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 COVID19 for clinical purposes. Overall outcome following exposure to COVID19 (response to virus, status of rheumatologic disease)

Details
Condition Systemic Autoimmune Diseases
Clinical Study IdentifierNCT04690816
SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Last Modified on22 October 2022

Eligibility

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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