Serological Surveillance for COVID-19 in Central North Carolina

It has been demonstrated that respiratory virus outbreaks and pandemics, such as influenza, SARS, MERS, and now the newly emerged SARS-CoV-2 virus, have a major impact on morbidity and mortality worldwide, as well as having devastating global economic and societal impact. During these outbreaks it is critical to gain a rapid understanding of the exposures and immunity in the general population. Identifying exposures can be accomplished through analysis of serum during an outbreak to identify those with specific antibodies to the pathogen.The knowledge of the level of exposures could greatly impact the response to current and future pandemics.

This study is a prospective, longitudinal, observational, single-center, exploratory, natural history study to collect samples and data from individuals to identify the presence and rate of development of anti-SARS-CoV-2 antibodies in North Carolina.

Objectives: Primary Objective:

To characterize the proportion of people with detectable antibodies to SARS-CoV-2 from a sampling of adults in North Carolina.

Exploratory Objectives:

• To identify the incidence of newly detectable antibodies to SARS-CoV-2 in the recruited cohort of adults in North Carolina over 12 months after enrollment
• To identify the rate of asymptomatic carriers of SARS-CoV-2 (PCR positive) among participants with detectable antibodies to SARS-CoV-2
• To associate presence or absence of detectable antibodies to SARS-CoV-2 with respiratory symptoms and future diagnosis with COVID-19
• To determine the natural history of antibody titers among the participants who are found to have detectable antibodies
• To associate demographic and medical factors with incidence of newly detectable antibodies to SARS-CoV-2

Endpoints: Primary Endpoint:

• Detection of Anti-SARS-CoV-2 antibodies by ELISA Assay Algorithm

Exploratory Endpoints:

• SARS-CoV-2 PCR of nasal swabs and correlation with serology
• Clinical questionnaire data and correlation with serology and PCR

• INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• Male and females
• greater than or equal to 18 years of age
• Able to read and speak English
• Ability to provide informed consent
• Able to travel to study visits at the NIEHS CRU for required study visits
• Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

• Current symptoms consistent with COVID-19 infection at the point of Antibody Visit 1
• Inability to provide a blood sample
• Current pregnancy or lactation, by participant verbal confirmation.
• Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures.
• Not willing to have blood samples stored for future research

Participants who have Limited English Proficiency will be excluded from the study because the informed consent form is only available in English. The study documents (Demographic and Health Assessment Questionnaire, and Weekly Symptom Questionnaire) and FDA Fact Sheets for Tests with Emergency Use Authorization are only available in English.

Decisionally impaired adults and prisoners will be excluded due to the inability to complete necessary study procedures. Adults who become prisoners or decisionally impaired while on study will be withdrawn.

Pregnant women are excluded due to the need to have participants venture out during the COVID-19 pandemic. Women who become pregnant during the study will be withdrawn.

Children will be excluded from enrolling in this study as immunity in children is different than

adults and we are focusing on adult immunity and in this trial