<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04490174</url>
  </required_header>
  <id_info>
    <org_study_id>200143</org_study_id>
    <secondary_id>20-E-0143</secondary_id>
    <nct_id>NCT04490174</nct_id>
  </id_info>
  <brief_title>Serological Surveillance for COVID-19 in Central North Carolina</brief_title>
  <official_title>Serological Surveillance for COVID-19 in Central North Carolina</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Environmental Health Sciences (NIEHS)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      The SARS-CoV-2 virus has caused a pandemic. Little is known about the virus, so data is&#xD;
      needed to form an effective public health response. Researchers want to count how many people&#xD;
      have been exposed to COVID-19, learn about symptoms, and find out how many antibodies to the&#xD;
      SARS-CoV-2 virus a person may have in their blood over 1 year. This data could affect the&#xD;
      response to current and future pandemics.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To learn how many people from a sampling of adults in North Carolina develop antibodies to&#xD;
      the SARS-CoV-2 virus over 1 year.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Healthy people age 18 and older who do not currently have COVID-19&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will be screened with questions about their health.&#xD;
&#xD;
      Participants will have five 30-minute visits at the Clinical Research Unit. At each visit,&#xD;
      they will have blood drawn to see if they have SARS-CoV-2 antibodies.&#xD;
&#xD;
      If the test result is positive for antibodies, the participant will be tested to see if they&#xD;
      currently have COVID-19. For this, a nasal or throat swab will be done, or saliva will be&#xD;
      collected. They may do this test at the same visit as the blood draw, or they may schedule an&#xD;
      extra visit.&#xD;
&#xD;
      Around the time of their study visits, participants will take an online survey about&#xD;
      themselves, their health, and COVID-19. It takes 10 minutes to complete. Every week for 52&#xD;
      weeks, they will also take a brief online survey about their symptoms. It takes 2 minutes to&#xD;
      complete. They will be emailed a link to log in and fill out the surveys on a secure website.&#xD;
&#xD;
      Participation will last for 1 year.&#xD;
&#xD;
      ...&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It has been demonstrated that respiratory virus outbreaks and pandemics, such as influenza,&#xD;
      SARS, MERS, and now the newly emerged SARS-CoV-2 virus, have a major impact on morbidity and&#xD;
      mortality worldwide, as well as having devastating global economic and societal impact.&#xD;
      During these outbreaks it is critical to gain a rapid understanding of the exposures and&#xD;
      immunity in the general population. Identifying exposures can be accomplished through&#xD;
      analysis of serum during an outbreak to identify those with specific antibodies to the&#xD;
      pathogen.The knowledge of the level of exposures could greatly impact the response to current&#xD;
      and future pandemics.&#xD;
&#xD;
      This study is a prospective, longitudinal, observational, single-center, exploratory, natural&#xD;
      history study to collect samples and data from individuals to identify the presence and rate&#xD;
      of development of anti-SARS-CoV-2 antibodies in North Carolina.&#xD;
&#xD;
      Objectives: Primary Objective:&#xD;
&#xD;
      To characterize the proportion of people with detectable antibodies to SARS-CoV-2 from a&#xD;
      sampling of adults in North Carolina.&#xD;
&#xD;
      Exploratory Objectives:&#xD;
&#xD;
        -  To identify the incidence of newly detectable antibodies to SARS-CoV-2 in the recruited&#xD;
           cohort of adults in North Carolina over 12 months after enrollment&#xD;
&#xD;
        -  To identify the rate of asymptomatic carriers of SARS-CoV-2 (PCR positive) among&#xD;
           participants with detectable antibodies to SARS-CoV-2&#xD;
&#xD;
        -  To associate presence or absence of detectable antibodies to SARS-CoV-2 with respiratory&#xD;
           symptoms and future diagnosis with COVID-19&#xD;
&#xD;
        -  To determine the natural history of antibody titers among the participants who are found&#xD;
           to have detectable antibodies&#xD;
&#xD;
        -  To associate demographic and medical factors with incidence of newly detectable&#xD;
           antibodies to SARS-CoV-2&#xD;
&#xD;
      Endpoints: Primary Endpoint:&#xD;
&#xD;
      - Detection of Anti-SARS-CoV-2 antibodies by ELISA Assay Algorithm&#xD;
&#xD;
      Exploratory Endpoints:&#xD;
&#xD;
        1. SARS-CoV-2 PCR of nasal swabs and correlation with serology&#xD;
&#xD;
        2. Clinical questionnaire data and correlation with serology and PCR&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 24, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Anti-SARS-COV-2 antibodies</measure>
    <time_frame>Day1, months 3, 6, 9, 12</time_frame>
    <description>Proportion of people with detectable Anti-SARS-COV-2 antibodies</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive SARS-CoV-2 PCR</measure>
    <time_frame>Day1, months 3, 6, 9, 12</time_frame>
    <description>To identify the rate of asymptomatic carriers of SARS-CoV-2 (PCR positive) among participants with detectable antibodies to SARS-CoV-2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detection of Anti-SARS-CoV-2 antibodies by ELISA Assay Algorithm</measure>
    <time_frame>Day1, months 3, 6, 9, 12</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detection of Anti-SARS-CoV-2 antibodies by ELISA Assay Algorithm</measure>
    <time_frame>Day1, months 3, 6, 9, 12</time_frame>
    <description>To determine the natural history of antibody titers among the participants who are found to have detectable antibodies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical questionnaires and ELISA antibody testing results</measure>
    <time_frame>Day1, months 3, 6, 9, 12</time_frame>
    <description>To associate presence or absence of detectable antibodies to SARS-CoV-2 with respiratory symptoms and future diagnosis with COVID-19</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical questionnaires and ELISA antibody testing results</measure>
    <time_frame>Day1, months 3, 6, 9, 12</time_frame>
    <description>To associate demographic and medical factors with incidence of newly detectable antibodies to SARS-CoV-2</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2500</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Healthy participants</arm_group_label>
    <description>Healthy adults without a current active COVID-19 infection or current symptoms consistent with COVID-19 at the first clinic visit</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy adults &gt;18 years age without a current active COVID-19 infection or current&#xD;
        symptoms consistent with COVID-19 within Central North Carolina.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
        In order to be eligible to participate in this study, an individual must meet all of the&#xD;
        following criteria:&#xD;
&#xD;
          1. Male and females&#xD;
&#xD;
          2. greater than or equal to 18 years of age&#xD;
&#xD;
          3. Able to read and speak English&#xD;
&#xD;
          4. Ability to provide informed consent&#xD;
&#xD;
          5. Able to travel to study visits at the NIEHS CRU for required study visits&#xD;
&#xD;
          6. Stated willingness to comply with all study procedures and availability for the&#xD;
             duration of the study&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        An individual who meets any of the following criteria will be excluded from participation&#xD;
        in this study:&#xD;
&#xD;
          1. Current symptoms consistent with COVID-19 infection at the point of Antibody Visit 1&#xD;
&#xD;
          2. Inability to provide a blood sample&#xD;
&#xD;
          3. Current pregnancy or lactation, by participant verbal confirmation.&#xD;
&#xD;
          4. Any condition that, in the investigator's opinion, places the participant at undue&#xD;
             risk for complications associated with required study procedures.&#xD;
&#xD;
          5. Not willing to have blood samples stored for future research&#xD;
&#xD;
        Participants who have Limited English Proficiency will be excluded from the study because&#xD;
        the informed consent form is only available in English. The study documents (Demographic&#xD;
        and Health Assessment Questionnaire, and Weekly Symptom Questionnaire) and FDA Fact Sheets&#xD;
        for Tests with Emergency Use Authorization are only available in English.&#xD;
&#xD;
        Decisionally impaired adults and prisoners will be excluded due to the inability to&#xD;
        complete necessary study procedures. Adults who become prisoners or decisionally impaired&#xD;
        while on study will be withdrawn.&#xD;
&#xD;
        Pregnant women are excluded due to the need to have participants venture out during the&#xD;
        COVID-19 pandemic. Women who become pregnant during the study will be withdrawn.&#xD;
&#xD;
        Children will be excluded from enrolling in this study as immunity in children is different&#xD;
        than&#xD;
&#xD;
        adults and we are focusing on adult immunity and in this trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stavros Garantziotis, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Environmental Health Sciences (NIEHS)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>NIEHS Join A Study Recruitment Group</last_name>
    <phone>(855) 696-4347</phone>
    <email>myniehs@nih.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stavros Garantziotis, M.D.</last_name>
    <phone>(984) 287-4412</phone>
    <email>garantziotis@mail.nih.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>NIEHS Clinical Research Unit (CRU)</name>
      <address>
        <city>Research Triangle Park</city>
        <state>North Carolina</state>
        <zip>27709</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>NIEHS Join A Study Recruitment Group</last_name>
      <phone>855-696-4347</phone>
      <email>myniehs@nih.gov</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2020-E-0143.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <reference>
    <citation>Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.</citation>
    <PMID>32064853</PMID>
  </reference>
  <reference>
    <citation>Tandon PN. COVID-19: Impact on health of people &amp; wealth of nations. Indian J Med Res. 2020 Feb &amp; Mar;151(2 &amp; 3):121-123. doi: 10.4103/ijmr.IJMR_664_20. No abstract available.</citation>
    <PMID>32202260</PMID>
  </reference>
  <reference>
    <citation>Dong L, Bouey J. Public Mental Health Crisis during COVID-19 Pandemic, China. Emerg Infect Dis. 2020 Jul;26(7):1616-1618. doi: 10.3201/eid2607.200407. Epub 2020 Jun 21.</citation>
    <PMID>32202993</PMID>
  </reference>
  <verification_date>May 31, 2023</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>June 1, 2023</last_update_submitted>
  <last_update_submitted_qc>June 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Natural History</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>.Undecided: It is not yet known if there will be a plan to make IPD available.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04490174
org study id: 200143
secondary id: 20-E-0143
nct id: NCT04490174
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.

      ...
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
measure: Anti-SARS-COV-2 antibodies
time frame: Day1, months 3, 6, 9, 12
description: Proportion of people with detectable Anti-SARS-COV-2 antibodies
measure: Positive SARS-CoV-2 PCR
time frame: Day1, months 3, 6, 9, 12
description: To identify the rate of asymptomatic carriers of SARS-CoV-2 (PCR positive) among participants with detectable antibodies to SARS-CoV-2
measure: Detection of Anti-SARS-CoV-2 antibodies by ELISA Assay Algorithm
time frame: Day1, months 3, 6, 9, 12
description: 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
measure: Detection of Anti-SARS-CoV-2 antibodies by ELISA Assay Algorithm
time frame: Day1, months 3, 6, 9, 12
description: To determine the natural history of antibody titers among the participants who are found to have detectable antibodies
measure: Clinical questionnaires and ELISA antibody testing results
time frame: Day1, months 3, 6, 9, 12
description: To associate presence or absence of detectable antibodies to SARS-CoV-2 with respiratory symptoms and future diagnosis with COVID-19
measure: Clinical questionnaires and ELISA antibody testing results
time frame: Day1, months 3, 6, 9, 12
description: To associate demographic and medical factors with incidence of newly detectable antibodies to SARS-CoV-2
arm group label: Healthy participants
description: Healthy adults without a current active COVID-19 infection or current symptoms consistent with COVID-19 at the first clinic visit
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stavros Garantziotis, M.D.
role: Principal Investigator
affiliation: National Institute of Environmental Health Sciences (NIEHS)
last name: NIEHS Join A Study Recruitment Group
phone: (855) 696-4347
email: myniehs@nih.gov
last name: Stavros Garantziotis, M.D.
phone: (984) 287-4412
email: garantziotis@mail.nih.gov
facility: 
status: Recruiting
contact: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2020-E-0143.html
description: NIH Clinical Center Detailed Web Page
citation: Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.
PMID: 32064853
citation: Tandon PN. COVID-19: Impact on health of people & wealth of nations. Indian J Med Res. 2020 Feb & Mar;151(2 & 3):121-123. doi: 10.4103/ijmr.IJMR_664_20. No abstract available.
PMID: 32202260
citation: Dong L, Bouey J. Public Mental Health Crisis during COVID-19 Pandemic, China. Emerg Infect Dis. 2020 Jul;26(7):1616-1618. doi: 10.3201/eid2607.200407. Epub 2020 Jun 21.
PMID: 32202993
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided
ipd description: .Undecided: It is not yet known if there will be a plan to make IPD available.