COVID-19's hidden toll on autoimmune patients revealed
NCT ID NCT04690816
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times
Summary
This study followed 293 people with autoimmune diseases and healthy volunteers to see how COVID-19 infection or vaccination affects their immune system, inflammation, and blood vessels. Participants were grouped based on their COVID-19 history and had up to 5 visits over 12-18 months, including blood tests, heart and lung checks, and sometimes a special scan. The goal was to understand how the body responds to COVID-19 in people with autoimmune conditions.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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293 people
The number who actually took part.
- Started
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Feb 2021
- Finished
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Dec 2024
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
primary clinical
- Ages
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15 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria as per respective group: 1. Stated willingness to comply with all study procedures and availability for the duration of the study 2. Male or female age greater than or equal to 15 years old with no upper age limit. 3. Ability of subject to understand and the willingness to sign a written informed consent and/or assent document. 4. 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. 5. 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). 6. 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. 7. 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) 8. Specific Inclusion Criteria for Systemic Autoimmunity Diseases Group: * 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). * Idiopathic inflammatory myopathies (IIM):Meets the 2017 EULAR/ACR Classification Criteria for Adult and Juvenile idiopathic inflammatory myopathies and their major subgroups. * Primary Sjogren's syndrome (SS): Meets 2016 ACR criteria. * Progressive systemic sclerosis (PSS): ACR/EULAR 2013 Classification criteria. * Immunologically mediated kidney diseases (IKD): Based on results from kidney biopsy consistent with immunologically mediated nephrotic syndrome and/or glomerulonephritis * Rheumatoid arthritis (RA): Meet the 2010 ACR/EULAR Classification Criteria. * Systemic autoimmunity syndrome not otherwise specified (SA-NOS): Patients not fulfilling criteria for a specific systemic autoimmune disease but with evidence of autoantibodies and clinical features suggestive of a systemic autoimmune disorder. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Pregnant and lactating subjects will be excluded because pregnancy and lactation modify immune responses and may interfere with correlations. 2. 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. 3. Concomitant medical, surgical or other conditions for which inadequate facilities are available to support their care at NIH. 4. Inability or unwillingness to comply with follow up requirements (e.g. distance, social, physical limitations). 5. 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) 6. Unwilling to participate in research studies or to provide research samples or data 7. Exclusion criteria for the (optional) vascular studies: -Healthy volunteers with known history of coronary artery disease, peripheral vascular disease or atherosclerosis. 8. Exclusion criteria for the (optional) FDGPET/CT scan: -Individuals younger than 18 years old will be excluded given the radiation exposure 9. Subjects with SAD and Healthy volunteers younger than 18 years old will be excluded from chest x-rays unless clinically indicated.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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Other studies related to the condition(s) this trial covers.
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