NCT04690816|Completed
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
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The Natural History of Coronavirus Disease (COVID-19) in Systemic Autoimmune Diseases; An Observational Prospective Study
Sponsor study identifier
Secondary identifiers
observational
293
1 country
1
Study Start
February 11, 2021
Actual (reported)Primary Completion
December 18, 2024
Actual (reported)Study Completion
December 18, 2024
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 18, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 30, 2020
Actual (reported)December 31, 2020
Actual (reported)February 11, 2021
Actual (reported)December 18, 2024
Actual (reported)December 18, 2024
Actual (reported)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...
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.
48 months
Understand prevalence and severity of COVID-19 in individuals with autoimmune diseases, and the variables that associate/predict these responses.
48 months
Healthy Volunteers to have a comparative group,without an underlying autoimmune disease or other significant medical problems
Patients with associated systemic autoimmune diseases.
primary clinical
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Gupta S, Nakabo S, Blanco LP, O'Neil LJ, Wigerblad G, Goel RR, Mistry P, Jiang K, Carmona-Rivera C, Chan DW, Wang X, Pedersen HL, Gadkari M, Howe KN, Naz F, Dell'Orso S, Hasni SA, Dempsey C, Buscetta A, Frischmeyer-Guerrerio PA, Kruszka P, Muenke M, Franco LM, Sun HW, Kaplan MJ. Sex differences in neutrophil biology modulate response to type I interferons and immunometabolism. Proc Natl Acad Sci U S A. 2020 Jul 14;117(28):16481-16491. doi: 10.1073/pnas.2003603117. Epub 2020 Jun 29.
Riphagen S, Gomez X, Gonzalez-Martinez C, Wilkinson N, Theocharis P. Hyperinflammatory shock in children during COVID-19 pandemic. Lancet. 2020 May 23;395(10237):1607-1608. doi: 10.1016/S0140-6736(20)31094-1. Epub 2020 May 7. No abstract available.
Mariana J Kaplan, M.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
293 participants (actual enrollment reported by the registry).
First Submitted
December 30, 2020
First Posted
December 31, 2020
Study Start
February 11, 2021
Actual (reported)Prophylactic Tranexamic Acid Reduces Postpartum Hemorrhage
Contact the study team to confirm eligibility.
Liu PP, Blet A, Smyth D, Li H. The Science Underlying COVID-19: Implications for the Cardiovascular System. Circulation. 2020 Jul 7;142(1):68-78. doi: 10.1161/CIRCULATIONAHA.120.047549. Epub 2020 Apr 15.
Primary Completion
December 18, 2024
Actual (reported)Study Completion
December 18, 2024
Actual (reported)Last Updated
October 26, 2026
Record last verified: 2026-03-26
project doesn t involve that level of data collection
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