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

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

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

Study Overview

• Status: Completed
• Conditions: Coronavirus Infections; Coronaviridae Infections; RNA Virus Infections; Virus Diseases; Asymptomatic Condition; Severe Acute Respiratory Syndrome Coronavirus 2; Communicable Disease; Infection Viral
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 6313

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Center for Environmental Medicine, Asthma and Lung Biology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients seen at UNC Outpatient clinics who are asymptomatic for COVID-19 infection

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Asymptomatic patients with an IgG response from SARS-CoV-2 infection.	Presence or absence of IgG antibodies to SARS-CoV2	at enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Asymptomatic patients with viral presence of SARS-CoV-2 infection.	swab for presence of SARS-CoV-2 virus	at enrollment

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: David B Peden, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2020
• Primary Completion (Actual): February 24, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: January 6, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; Pandemic; COVID-19 virus testing
• Additional Relevant MeSH Terms: Pathologic Processes; Nidovirales Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Severe Acute Respiratory Syndrome; Coronavirus Infections; Infections; Communicable Diseases; Virus Diseases; Asymptomatic Diseases; RNA Virus Infections; Coronaviridae Infections; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulin G
• Other Study ID Numbers: 20-0937

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No