Natural History of Coronavirus Disease (COVID-19) in Systemic Autoimmune Diseases
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04690816|
Recruitment Status : Recruiting
First Posted : December 31, 2020
Last Update Posted : October 12, 2022
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.
To understand how COVID-19 affects inflammation, the immune system, and blood vessels in adults and children with autoimmune diseases.
People ages 15 and older who have been diagnosed with an autoimmune disease or are a healthy volunteer
Participants will have a screening visit. This will include:
Medical history and physical exam
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.
|Condition or disease|
|Systemic Autoimmune Diseases|
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)
|Study Type :||Observational|
|Estimated Enrollment :||350 participants|
|Official Title:||The Natural History of Coronavirus Disease (COVID-19) in Systemic Autoimmune Diseases; An Observational Prospective Study|
|Actual Study Start Date :||February 11, 2021|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||December 31, 2024|
Healthy Volunteers to have a comparative group,without an underlying autoimmune disease or other significant medical problems
Systemic Autoimmune Diseases
Patients with associated systemic autoimmune diseases.
- 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 syste... [ Time Frame: 36 months ]Measures of Immune dysregulation (gene expression changes in immune cells, immune cell subset proportions, serum cytokine and autoantibody levels and repertoire), vasculopathy (changes in vascular function tests (CAVI, Endopat and sphygmocor quantification) and , in some cases, vascular inflammation (as measured by FDG-PET CT) before and after COVID-19.
- Understand prevalence and severity of COVID-19 in individuals with autoimmune diseases, and the variables that associate/predict these responses. [ Time Frame: 36 months ]Clinical outcomes, as assessed by disease-specific activity/severity measures in response to COVID infection. Response to potential antiviral treatments and/or vaccines that are used for clinical reasons in response to COVID-19 exposure or prevention.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04690816
|Contact: Elaine B Poncio||(301) email@example.com|
|Contact: Mariana J Kaplan, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Mariana J Kaplan, M.D.||National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)|