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)
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:
- Those with previously documented COVID-19 infection or COVID vaccination
- Those with a recently known COVID-19 exposure or vaccination
- Those with no known COVID-19 exposure or vaccination
- 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 Identifier | NCT04690816 |
| Sponsor | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| Last Modified on | 22 October 2022 |
Eligibility
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
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.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf 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 moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer