NCT04690816

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 293 (actual)
• Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · NIH
• Sex: All
• Age: 15 Years
• Healthy volunteers: Accepted

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.

Detailed description

Study 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. Objectives: Primary Objective: Characterize how COVID-19 modulates systemic inflammation, autoimmunity features, organ damage and vasculopathy in adult and pediatric patients with a diagnosis of systemic autoimmunity. Characterize how exposure to a COVID vaccine modulates systemic inflammation, autoimmunity features and vasculopathy in adult and pediatric patients with a 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. Endpoints: 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 COVID-19 for clinical purposes. Overall outcome following exposure to COVID-19 and/or COVID vaccine (response to virus, status of rheumatologic disease)

Conditions

• Systemic Autoimmune Diseases

Timeline

• Start date: 2021-02-11
• Primary completion: 2024-12-18
• Completion: 2024-12-18
• First posted: 2020-12-31
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States