Clinical trial: Natural History of Coronavirus Disease (COVID-19) in Systemic Autoimmune Diseases (NCT04690816)

Eligibility criteria:
-  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
             SARSCOV-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 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
                  utoimmune 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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 15 Years old.


Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Entailment