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

Virus Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04367740
• Other study ID #: 20-0937
• Status: Completed
• Start date: April 28, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: January 2022
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6313
• Est. completion date: February 28, 2022
• Est. primary completion date: February 24, 2022
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Asymptomatic Condition
• Asymptomatic Diseases
• Communicable Disease
• Communicable Diseases
• Coronaviridae Infections
• Coronavirus Infections
• Infection Viral
• Infections
• RNA Virus Infections
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome Coronavirus 2
• Virus Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Center for Environmental Medicine, Asthma and Lung Biology	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Asymptomatic patients with viral presence of SARS-CoV-2 infection.	swab for presence of SARS-CoV-2 virus	at enrollment