Systemic Autoimmune DiseasesNCT04690816
Natural History of Coronavirus Disease (COVID-19) in Systemic Autoimmune Diseases
An observational study of Systemic Autoimmune Diseases, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Autoimmune Diseases
- How many people
- 293 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2021to 18 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: primary clinical
Who may be able to join
- 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.
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- 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)
- 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.
Who cannot join
- 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)
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- Unwilling to participate in research studies or to provide research samples or data
- Exclusion criteria for the (optional) vascular studies:
- -Healthy volunteers with known history of coronary artery disease, peripheral vascular disease or atherosclerosis.
- Exclusion criteria for the (optional) FDGPET/CT scan:
- -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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: The Natural History of Coronavirus Disease (COVID-19) in Systemic Autoimmune Diseases; An Observational Prospective Study
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.
Read more
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:
- 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.
Read the 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
- Keywords
- COVID-19 Study, Natural History of Coronavirus Disease (COVID-19) in Systemic Autoimmune Disease, An Observational Prospective Study for COVID-19, Natural History
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start11 Feb 2021
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Systemic Autoimmune DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mariana J Kaplan, M.D., Principal investigator, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690816
- Sponsor's protocol ID
- 10000207
- Other IDs
- 000207-AR
- Status last verified
- 26 Mar 2026
- First submitted
- 30 Dec 2020
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: project doesn t involve that level of data collection
Publications
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.
PubMed 32601182Riphagen 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.
PubMed 32386565Liu 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.
PubMed 32293910
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural History of Coronavirus Disease (COVID-19) in Systemic Autoimmune Diseases; An Observational Prospective Study
- ClinicalTrials.gov ID
- NCT04690816
- Acronym / sponsor ID
- 10000207
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary clinical
Key inclusion criteria (22 listed)
- 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:
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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: 48 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.
1 secondary outcome
Understand prevalence and severity of COVID-19 in individuals with autoimmune diseases, and the variables that associate/predict these responses.
Time frame: 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 32601182Gupta 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.
- Background: PubMed 32386565Riphagen 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.
- Background: PubMed 32293910Liu 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. project doesn t involve that level of data collection
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariana J Kaplan, M.D. principal investigator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Autoimmune Diseases, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04690816, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.