Purpose: To determine the number of asymptomatic individuals who have antibodies to SARS-CoV-2, the virus which causes COVID-19
ScreenNC is design ed for comprehensive virus screening and serology to assess exposure to
SAR-CoV2 in persons not-indicated for COVID-19 testing as per the CDC screening algorithm and
implemented at UNC Health Care (at the time of activation). This trial is designed to
generate point prevalence of infected (I) persons, independent of clinical symptoms. The
susceptible (S) class is the number of COVID-19 tested by any FDA-approved NP swab test or a
SARS-CoV2 IgG antibody test. At present FDA does not have approved SARS-CoV serology and such
serology is not used for diagnosis of acute infection. The recovered (R) class is the number
of positives. This information allows for modeling of the COVID-19 epidemic in NC. The
investigation is not testing the effectiveness or safety of either of these testing
modalities, though serology may be offered in the future by UNC Healthcare laboratories. The
blood samples to be obtained assess development of host response to SARS-CoV2 infection.
ScreenNC will be implemented within the logistic and clinical limitations of the current
outbreak. This is a single visit study. Since there is a shortage of PPE the investigators
will rely on screening at locations different then the screening of presumed infected
persons. Additionally, due to logistical considerations, volunteers may have a viral swab
(nasopharyngeal or oropharyngeal) and/or a blood sample obtained. Thus, at recruitment,
volunteers may be asked to give both samples or only one.
Viral load testing will be done at LabCorp and/or UNC labs using compatible assays (Roche,
ThermoFischer , WHO). Confirmatory testing (other PCR, sequencing, culture) will be done at
UNC. Blood samples will be tested at the McClendon Clinical Immunology laboratory for IgG
antibodies against SARS-CoV2.
Because these patients are in the UNC Health Care system, The investigators will have access
to their medical records, which will provide very granular information as to co-morbidities
and other demographic factors which can be assessed in the context of SAR-CoV-2 (COVID-19)
infection status. Future analyses of this cohort will employ statistical methods which allow
us to account for sampling bias of this convenience sample to construct a representative
sample of the state of NC .
Diagnostic Test: To assess for development of IgG antibodies against SARS-CoV2
Swabs will be collected to assess for COVID-19 if PPE supplies allow.
Other Name: Array
Inclusion Criteria:
- Individuals aged 18-99 who arrive at any participating UNC Healthcare clinic for care
and who have a medical record in UNC EPIC.
- Patients may be included if they have completed the quarantine as recommended by the
CDC and at least 4 weeks since the initial positive COVID-19 NP test.
Exclusion Criteria:
- Any individual arriving at any participating UNC Healthcare clinic for diagnosis or
treatment of respiratory symptoms meeting the following COVID-19 clinical evaluation
criteria:
1. Developed non-allergy respiratory symptoms of cough or shortness of breath in the
past 7 days
AND
2. Meet ONE OR MORE of these criteria
- Had close contact (within 6 feet for 10 or more minutes) with a person
diagnosed with COVID-19
- Works in a healthcare setting
- Is pregnant or postpartum within 2 weeks of delivery
- Is morbidly obese: BMI = 40 or 100 pounds over ideal body weight
- Diabetes mellitus
- Immunosuppression, including caused by medications or by HIV infection
- Pulmonary disease, including asthma
- Cardiovascular disease
- Hypertensive disease
- Renal disease
- Hepatic disease
- Hematologic disease, including sickle cell disease
- Neurological condition that limits movement
- Moderate to severe developmental delay
Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, United States
David B Peden, MD, Principal Investigator
University of North Carolina, Chapel Hill