Serological Surveillance for COVID-19 in Central North Carolina
Condition: COVID-19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Background:

      The SARS-CoV-2 virus has caused a pandemic. Little is known about the virus, so data is
      needed to form an effective public health response. Researchers want to count how many people
      have been exposed to COVID-19, learn about symptoms, and find out how many antibodies to the
      SARS-CoV-2 virus a person may have in their blood over 1 year. This data could affect the
      response to current and future pandemics.

      Objective:

      To learn how many people from a sampling of adults in North Carolina develop antibodies to
      the SARS-CoV-2 virus over 1 year.

      Eligibility:

      Healthy people age 18 and older who do not currently have COVID-19

      Design:

      Participants will be screened with questions about their health.

      Participants will have five 30-minute visits at the Clinical Research Unit. At each visit,
      they will have blood drawn to see if they have SARS-CoV-2 antibodies.

      If the test result is positive for antibodies, the participant will be tested to see if they
      currently have COVID-19. For this, a nasal or throat swab will be done, or saliva will be
      collected. They may do this test at the same visit as the blood draw, or they may schedule an
      extra visit.

      Around the time of their study visits, participants will take an online survey about
      themselves, their health, and COVID-19. It takes 10 minutes to complete. Every week for 52
      weeks, they will also take a brief online survey about their symptoms. It takes 2 minutes to
      complete. They will be emailed a link to log in and fill out the surveys on a secure website.

      Participation will last for 1 year.

      ...
    

Detailed description: 
      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:

        1. SARS-CoV-2 PCR of nasal swabs and correlation with serology

        2. Clinical questionnaire data and correlation with serology and PCR
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults >18 years age without a current active COVID-19 infection or current
        symptoms consistent with COVID-19 within Central North Carolina.
      
Keywords: SARS-CoV-2; Natural History