ScreenNC, a Study to Determine the Number of Asymptomatic Individuals Who Have Antibodies to the Virus That Causes COVID-19

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04367740

Collaborator

(none)

10,000

Enrollment

Location

31.1

Anticipated Duration (Months)

321.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Purpose: To determine the number of asymptomatic individuals who have antibodies to SARS-CoV-2, the virus which causes COVID-19

Condition or Disease	Intervention/Treatment	Phase
Asymptomatic Condition Infection Viral Coronavirus Infections Severe Acute Respiratory Syndrome Coronavirus 2 Coronaviridae Infections RNA Virus Infections Virus Diseases Communicable Disease	Diagnostic Test: To assess for development of IgG antibodies against SARS-CoV2

Detailed Description

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 .

Study Design

Study Type:

Observational

Anticipated Enrollment :

10000 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

ScreenNC: A Study to Determine the Number of Asymptomatic Individuals Who Have Antibodies to the SARS-CoV-2 Infection

Actual Study Start Date :

Apr 28, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Serum Antibodies Blood samples to be obtained assess for IgG antibodies against SARS-CoV2	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 Names: Nasopharyngeal Swab Oropharyngeal Swab

Arm

Intervention/Treatment

Serum Antibodies

Blood samples to be obtained assess for IgG antibodies against SARS-CoV2

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 Names:

Nasopharyngeal Swab

Oropharyngeal Swab

Outcome Measures

Primary Outcome Measures

Percentage of Asymptomatic patients with an IgG response from SARS-CoV-2 infection. [at enrollment]
Presence or absence of IgG antibodies to SARS-CoV2

Secondary Outcome Measures

Percentage of Asymptomatic patients with viral presence of SARS-CoV-2 infection. [at enrollment]
swab for presence of SARS-CoV-2 virus

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

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:

Developed non-allergy respiratory symptoms of cough or shortness of breath in the past 7 days

AND

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