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

NCT04690816 | Completed

• 2 other identifiers: 10000207000207-AR
• Study Type: observational
• Target: 293
• Locations: 1 country
• Sites: 1

Brief 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. 1.Those with previously documented COVID-19 infection or COVID vaccination
2. 2.Those with a recently known COVID-19 exposure or vaccination
3. 3.Those with no known COVID-19 exposure or vaccination
4. 4.Those who developed an acute COVID-19 infection

Conditions

Systemic Autoimmune Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Understand prevalence and severity of COVID-19 in individuals with autoimmune diseases, and the variables that associate/predict these responses.

  48 months

Study Arms (2)

Healthy Volunteers

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.

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary clinical

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria as per respective group:
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female age greater than or equal to 15 years old with no upper age limit.
• Ability of subject to understand and the willingness to sign a written informed consent and/or assent document.
• For Healthy Volunteers Group:
• Age greater than or equal to 15 with no upper age limit.
• No history of autoimmune diseases and in good general health as evidenced by medical history.
• For symptomatic COVID-19 group must have laboratory evidence (positive PCR for SARS-COV-2 or other test developed after this proposal gets approved and is available through the Clinical Center) and one of the signs and symptoms associated with COVID-19 infection (e.g. fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea).
• For post COVID-19 study visits must have laboratory evidence (e.g. positive PCR for SARS- COV-2, antibody against SARS-COV-2 or other test developed after this proposal gets approved) of current or prior exposure to COVID-19. Alternatively, patients should have documented evidence of having received one of the SARS-COV-2 vaccines that may become available during the study.
• For subjects with known COVID exposure, they must fulfill one of the following criteria:
• A minimum of 28 days has passed since the initial positive test date AND B. Resolution of fever was greater than or equal to7 days ago (without the use of fever-reducing medications) AND C. Resolution of respiratory symptoms was greater than or equal to7 days ago, OR
• A minimum of 10 days has passed since the initial positive test AND B. A minimum of 2 consecutive oropharyngeal swabs OR 2 consecutive nasopharyngeal swabs or Mid-turbinate Swabs or 2 saliva testing collected greater than or equal to 24 hours apart that are negative for SARS CoV-2 PCR A positive PCR requires restarting the series of swabs (wait 5 days to retest)
• Age greater than or equal to 15 years with no upper age limit
• Systemic lupus erythematosus (SLE): Meets at least 4 of 11 modified American College of Rheumatology (ACR) (1997) Revised Criteria for the Classification of Systemic Lupus Erythematosus or Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for systemic lupus erythematosus.
• Anti-neutrophil cytoplasmic antibody associated vasculitis (AAV): Meet Revised 1990 ACR criteria for Granulomatosis with polyangiitis (GPA) or the 2012 Chapel Hill Nomenclature for microscopic polyangiitis (MPA).

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Pregnant and lactating subjects will be excluded because pregnancy and lactation modify immune responses and may interfere with correlations.
• Concomitant medical problems which would confound the interpretation of studies gathered by this protocol. Included in this is the presence of HIV in the blood, active malignancies, or other significant medical conditions that may interferes with interpretation of studies.
• Concomitant medical, surgical or other conditions for which inadequate facilities are available to support their care at NIH.
• Inability or unwillingness to comply with follow up requirements (e.g. distance, social, physical limitations).
• Any comorbidity of medical or psychological/psychiatric condition or treatment, that in the opinion of the Principal Investigator, would exclude the subjects from the research studies (e.g. Patient requiring urgent and/or acute medical care, surgical or other procedures)
• Unwilling to participate in research studies or to provide research samples or data
• Healthy volunteers with known history of coronary artery disease, peripheral vascular disease or atherosclerosis.
• Individuals younger than 18 years old will be excluded given the radiation exposure
• Subjects with SAD and Healthy volunteers younger than 18 years old will be excluded from chest x-rays unless clinically indicated.

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 32601182 BACKGROUND

• 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.

  PMID: 32386565 BACKGROUND

• 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.

  PMID: 32293910 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mariana J Kaplan, M.D.

  National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: December 31, 2020
• Study Start: February 11, 2021
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: March 30, 2026

Record last verified: 2026-03-26

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)