<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/NCT04424004</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00105703</org_study_id>
    <nct_id>NCT04424004</nct_id>
  </id_info>
  <brief_title>MURDOCK Cabarrus County COVID-19 Prevalence and Immunity (C3PI) Study</brief_title>
  <acronym>C3PI</acronym>
  <official_title>MURDOCK Cabarrus County COVID-19 Prevalence and Immunity (C3PI) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>North Carolina Department of Health and Human Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this research is to:&#xD;
&#xD;
        -  Assess perceptions, concerns, and practices related to the COVID-19 pandemic and&#xD;
           mitigation strategies using the MURDOCK Study Community Registry and Biorepository&#xD;
           population as a measure of these features in Cabarrus County through a biweekly&#xD;
           electronic survey.&#xD;
&#xD;
        -  Estimate the prevalence and change in prevalence of COVID-19 infection based on&#xD;
           responses to questionnaire items on symptoms and practices using a biweekly electronic&#xD;
           survey.&#xD;
&#xD;
        -  Among respondents to the baseline questionnaire, conduct at home mid-turbinate nasal&#xD;
           swab collection for viral PCR testing for active COVID-19 infection as an estimate of&#xD;
           the prevalence of active infection in Cabarrus County.&#xD;
&#xD;
        -  Among respondents to the baseline questionnaire, conduct serologic testing for IgG&#xD;
           antibodies to SARS-CoV-2 as an estimate of the prevalence of exposure and potential&#xD;
           immunity to COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Method:&#xD;
&#xD;
      Questionnaire The investigators will use RedCap to introduce the study, obtain online&#xD;
      informed consent, and administer an electronic questionnaire to MURDOCK Study participants&#xD;
      currently residing in North Carolina who have a valid email address on file (N~7200). The&#xD;
      question bank for the questionnaire is attached to the application. It includes demographics,&#xD;
      education and employment, and questions about symptoms, contacts and exposures, the&#xD;
      participant's household, behaviors, and practice of mitigation strategies. The opportunity to&#xD;
      enroll and complete the baseline questionnaire will remain open for 1 month. Follow up&#xD;
      surveys will be made available to consented participants on the same day for each week they&#xD;
      are administered. The investigators anticipate a 20% response rate to the survey (N~1500).&#xD;
      Recruitment materials, consent and questionnaires, materials related to return of results to&#xD;
      participants, and verbal study communications will be available in both English and Spanish.&#xD;
&#xD;
      COVID-19 PCR testing A randomly selected subset of individuals who consent to participate&#xD;
      (N~300-500 initially, with the potential to expand testing to more survey participants as&#xD;
      additional funding becomes available), weighted to ensure representation by race/ethnicity,&#xD;
      age, and sex, will be invited to participate in COVID-19 polymerase chain reaction (PCR)&#xD;
      viral testing by at-home collection and return of self-administered nasal swabs. Saliva&#xD;
      specimens may replace the nasal swab specimen. Specimens will be collected at baseline and&#xD;
      every 2 weeks in conjunction with questionnaire administration. Participants will have the&#xD;
      opportunity to opt out of participation in this component at the time of consent and&#xD;
      enrollment. Those who do not opt out will be eligible for the random selection for COVID-19&#xD;
      testing. The investigators will provide specimen collection materials and instructions for&#xD;
      collection, along with return shipping instructions to participants in pre-prepared kits.&#xD;
      COVID-19 PCR testing will be conducted at the North Carolina State Laboratory of Public&#xD;
      Health. This is a CLIA-certified laboratory. Samples for COVID-19 PCR testing will be&#xD;
      identified only by a unique study identification number for each participant. Results of&#xD;
      COVID-19 testing will be returned from the State Lab to the MURDOCK Study investigative team&#xD;
      as results are available from testing (expected turnaround time ~4 days from receipt at State&#xD;
      Lab) by secure transfer for incorporation into the RedCap study database.&#xD;
&#xD;
      COVID-19 serology testing The same randomly selected subset of individuals who collect&#xD;
      at-home samples for COVID-19 PCR testing (N~300-500 initially, with the potential expand to&#xD;
      more survey participants as additional resources become available), will also provide a blood&#xD;
      sample for serologic testing for SARS-CoV-2 IgG antibodies. Specimens will be collected by&#xD;
      routine venipuncture at the MURDOCK Study office in Kannapolis, NC and potentially 2-3&#xD;
      additional locations in Cabarrus County. Study visits for venipuncture will be deferred for 2&#xD;
      weeks in participants whose nasal swab PCR testing for COVID-19 is positive. Participants&#xD;
      will be screened for COVID-19 symptoms at the time of scheduling the visit for venipuncture&#xD;
      and at arrival for the visit. Participants who screen positive for COVID-19 symptoms will be&#xD;
      referred for clinical COVID-19 testing and will have their initial serology testing deferred&#xD;
      until a negative clinical test is documented or for 2 weeks if clinical testing is not&#xD;
      performed.&#xD;
&#xD;
      Specimens for serology will be collected at baseline approximately 1 month after the first&#xD;
      questionnaire and 2 weeks after the first nasal swab collection and COVID-19 PCR testing.&#xD;
      Specimens for serology will be collected at least bi-monthly and up to monthly thereafter&#xD;
      through a total study duration of 6, and up to 12, months. SARS-CoV-2 serologic testing for&#xD;
      IgG antibodies will be conducted in the laboratory of Thomas Denny, MSc, MPhil in the Duke&#xD;
      Human Vaccine Institute on the campus of Duke University Medical Center using a commercial&#xD;
      IgG assay (Perkin-Elmer). Samples for serology will be identified only by a unique study&#xD;
      identification number for each participant. Results of serological testing will be returned&#xD;
      from the Denny laboratory to the MURDOCK Study investigative team at regular, prespecified&#xD;
      intervals by secure transfer for incorporation into the RedCap study database. The Denny&#xD;
      laboratory is CLIA-certified. Any residual serum after SARS-CoV-2 serologic testing will be&#xD;
      frozen at -80°C and stored for future use in the Duke COVID-19 Biorepository (Pro00105316).&#xD;
&#xD;
      Return of Results to Participants:&#xD;
&#xD;
      The investigators will share aggregate results from questionnaires and testing with all&#xD;
      participants and the public through multiple routes, including email, social media and the&#xD;
      press and with the scientific community through presentations at scientific meetings and&#xD;
      publications. The investigators will also provide regular reports on accruing study data to&#xD;
      NCDHHS. Participants will not be identified individually in these aggregate reports. The&#xD;
      investigators also will return the results of both COVID-19 PCR testing and serologic testing&#xD;
      for SARS-CoV-2 antibodies to individual study participants. Individual return of results will&#xD;
      follow the following principles:&#xD;
&#xD;
      COVID-19 test results. A standard template for return of negative COVID-19 test results will&#xD;
      be IRB approved and used to notify participants of their results. If a participant tests&#xD;
      positive for COVID-19, the participant will be contacted by phone by the study PI or a&#xD;
      designate to convey the result. General recommendations for participants who test positive&#xD;
      will be IRB approved. The investigators will also offer these participants a link through&#xD;
      which they can consider participation in the Duke COVID Community Watch support program&#xD;
      (Pro00105189). Positive COVID-19 test results will also be reported to the local/state health&#xD;
      department.&#xD;
&#xD;
      SARS-CoV-2 serology results. An IRB approved standard template will be used to convey the&#xD;
      results of SARS-CoV-2 serology to participants. Care will be taken to ensure that&#xD;
      participants understand what information the results of their SARS-CoV-2 serology conveys&#xD;
      (and does not convey) in order to avoid any risk of misinterpretation, particularly of&#xD;
      positive results.&#xD;
&#xD;
      Selection of Subjects&#xD;
&#xD;
      List inclusion/exclusion criteria and how subjects will be identified. The MURDOCK NCDHHS&#xD;
      COVID-19 Prevalence Study will examine COVID-19 prevalence and SARS-CoV-2 antibody prevalence&#xD;
      in Cabarrus County, NC by leveraging the community-based cohort enrolled in the MURDOCK Study&#xD;
      Community Registry and Biorepository (MURDOCK Study). The MURDOCK Study is an ongoing&#xD;
      longitudinal health study operated by the Translational Population Health Research Center in&#xD;
      the Duke Clinical &amp; Translational Science Institute and approved by the Duke University&#xD;
      Institutional Review Board (Duke IRB Pro00011196). The MURDOCK Study recruited 12,526&#xD;
      residents from 20 Zip Codes in the Cabarrus County/Kannapolis region, and currently follows&#xD;
      10,407 active participants. As part of the MURDOCK Study, all participants provided&#xD;
      demographic, clinical, and behavioral data via an enrollment questionnaire, were geospatially&#xD;
      mapped at the street address level, and consented to a yearly follow up questionnaire. They&#xD;
      also provided consent to be contacted by MURDOCK Study staff up to four times per year to&#xD;
      consider participation in future research opportunities. A recent protocol communication to&#xD;
      the IRB was approved to allow additional contacts for high priority COVID-19 research studies&#xD;
      (Pro00011196-SE-45.0). Our study population for this protocol will include approximately 7200&#xD;
      active MURDOCK Study participants who currently reside in North Carolina and have a valid&#xD;
      email address on file. The active study participants who receive a recruitment email and&#xD;
      consent to participate (estimated 20%) will have the opportunity to declare their interest in&#xD;
      testing and from among those 300-500 will be randomly selected to participate in the testing.&#xD;
      The anticipated number to enroll is set at 1,000 but may be adjusted up based on response&#xD;
      rate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 9, 2020</start_date>
  <completion_date type="Actual">December 2, 2021</completion_date>
  <primary_completion_date type="Actual">December 2, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Estimate the prevalence of COVID-19 infection based on responses to questionnaire items on symptoms and practices using a biweekly electronic survey.</measure>
    <time_frame>6 months</time_frame>
    <description>RedCap link will be sent to participants electronically and they will complete and submit the questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess perceptions, concerns, and practices related to the COVID-19 pandemic and mitigation strategies</measure>
    <time_frame>6 months</time_frame>
    <description>This will be accomplished using the MURDOCK Study Community Registry and Biorepository (Pro00011196) population as a measure of these features in Cabarrus County through a biweekly electronic survey</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimate of the prevalence of active infection in Cabarrus County.</measure>
    <time_frame>6 months</time_frame>
    <description>Among respondents to the baseline questionnaire, conduct bi-weekly at home anterior nares swab collection for viral PCR testing for active COVID-19 infection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimate of the prevalence of exposure and potential immunity to COVID-19.</measure>
    <time_frame>6 months</time_frame>
    <description>Among respondents to the baseline questionnaire, conduct bimonthly serologic testing for IgG antibodies to SARS-CoV-2</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>COVID 19</condition>
  <arm_group>
    <arm_group_label>MURDOCK Study Participants with valid email address</arm_group_label>
    <description>Randomized for testing: 1.A randomly selected subset of individuals who consent to participate (N~300-500), will be invited to participate in COVID-19 polymerase chain reaction (PCR) viral testing by at-home collection and return of self-administered nasal swabs. Saliva specimens may replace the nasal swab specimen.&#xD;
2. The same randomly selected subset of individuals who collect at-home samples for COVID-19 PCR testing (N~300-500), will also provide a blood sample for serologic testing for SARS-CoV-2 IgG antibodies.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>COVID-19 PCR and serology testing</intervention_name>
    <description>PCR testing: participate will conduct at-home collection and return of self-administered nasal swabs for COVID-19 polymerase chain reaction (PCR) viral testing. Saliva specimens may replace the nasal swab specimen. Specimens will be collected at baseline and every 2 weeks in conjunction with questionnaire administration.&#xD;
Serology testing: The same randomized participants will also provide a blood sample for serologic testing for SARS-CoV-2 IgG antibodies. Specimens will be collected by routine venipuncture at the MURDOCK Study office in Kannapolis, NC.Specimens for serology will be collected at baseline approximately 1 month after the first questionnaire and 2 weeks after the first nasal swab collection and COVID-19 PCR testing. Specimens for serology will be collected at least bi-monthly and up to monthly thereafter through a total study duration of 6, and up to 12, months.</description>
    <arm_group_label>MURDOCK Study Participants with valid email address</arm_group_label>
    <other_name>COVID-19 PCR testing</other_name>
    <other_name>COVID-19 serology testing</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Nose Swabs and Plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        ALL active MURDOCK study participants who currently reside in North Carolina and have a&#xD;
        valid email address. The demographics of the MURDOCK study cohort are representative of the&#xD;
        population in Cabarrus County and North Carolina.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  MURDOCK Study participants ( Pro00011196) currently residing in North Carolina who&#xD;
             have a valid email address on file.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  MURDOCK Study participants ( Pro00011196) currently not residing in North Carolina&#xD;
&#xD;
          -  MURDOCK Study participants without a valid email address on file.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristin Newby, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke CTSI Translational Population Health Office</name>
      <address>
        <city>Kannapolis</city>
        <state>North Carolina</state>
        <zip>28081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>January 20, 2022</last_update_submitted>
  <last_update_submitted_qc>January 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>No</sharing_ipd>
  </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/NCT04424004
org study id: Pro00105703
nct id: NCT04424004
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objectives of this research is to:

        -  Assess perceptions, concerns, and practices related to the COVID-19 pandemic and
           mitigation strategies using the MURDOCK Study Community Registry and Biorepository
           population as a measure of these features in Cabarrus County through a biweekly
           electronic survey.

        -  Estimate the prevalence and change in prevalence of COVID-19 infection based on
           responses to questionnaire items on symptoms and practices using a biweekly electronic
           survey.

        -  Among respondents to the baseline questionnaire, conduct at home mid-turbinate nasal
           swab collection for viral PCR testing for active COVID-19 infection as an estimate of
           the prevalence of active infection in Cabarrus County.

        -  Among respondents to the baseline questionnaire, conduct serologic testing for IgG
           antibodies to SARS-CoV-2 as an estimate of the prevalence of exposure and potential
           immunity to COVID-19.
Method:

      Questionnaire The investigators will use RedCap to introduce the study, obtain online
      informed consent, and administer an electronic questionnaire to MURDOCK Study participants
      currently residing in North Carolina who have a valid email address on file (N~7200). The
      question bank for the questionnaire is attached to the application. It includes demographics,
      education and employment, and questions about symptoms, contacts and exposures, the
      participant's household, behaviors, and practice of mitigation strategies. The opportunity to
      enroll and complete the baseline questionnaire will remain open for 1 month. Follow up
      surveys will be made available to consented participants on the same day for each week they
      are administered. The investigators anticipate a 20% response rate to the survey (N~1500).
      Recruitment materials, consent and questionnaires, materials related to return of results to
      participants, and verbal study communications will be available in both English and Spanish.

      COVID-19 PCR testing A randomly selected subset of individuals who consent to participate
      (N~300-500 initially, with the potential to expand testing to more survey participants as
      additional funding becomes available), weighted to ensure representation by race/ethnicity,
      age, and sex, will be invited to participate in COVID-19 polymerase chain reaction (PCR)
      viral testing by at-home collection and return of self-administered nasal swabs. Saliva
      specimens may replace the nasal swab specimen. Specimens will be collected at baseline and
      every 2 weeks in conjunction with questionnaire administration. Participants will have the
      opportunity to opt out of participation in this component at the time of consent and
      enrollment. Those who do not opt out will be eligible for the random selection for COVID-19
      testing. The investigators will provide specimen collection materials and instructions for
      collection, along with return shipping instructions to participants in pre-prepared kits.
      COVID-19 PCR testing will be conducted at the North Carolina State Laboratory of Public
      Health. This is a CLIA-certified laboratory. Samples for COVID-19 PCR testing will be
      identified only by a unique study identification number for each participant. Results of
      COVID-19 testing will be returned from the State Lab to the MURDOCK Study investigative team
      as results are available from testing (expected turnaround time ~4 days from receipt at State
      Lab) by secure transfer for incorporation into the RedCap study database.

      COVID-19 serology testing The same randomly selected subset of individuals who collect
      at-home samples for COVID-19 PCR testing (N~300-500 initially, with the potential expand to
      more survey participants as additional resources become available), will also provide a blood
      sample for serologic testing for SARS-CoV-2 IgG antibodies. Specimens will be collected by
      routine venipuncture at the MURDOCK Study office in Kannapolis, NC and potentially 2-3
      additional locations in Cabarrus County. Study visits for venipuncture will be deferred for 2
      weeks in participants whose nasal swab PCR testing for COVID-19 is positive. Participants
      will be screened for COVID-19 symptoms at the time of scheduling the visit for venipuncture
      and at arrival for the visit. Participants who screen positive for COVID-19 symptoms will be
      referred for clinical COVID-19 testing and will have their initial serology testing deferred
      until a negative clinical test is documented or for 2 weeks if clinical testing is not
      performed.

      Specimens for serology will be collected at baseline approximately 1 month after the first
      questionnaire and 2 weeks after the first nasal swab collection and COVID-19 PCR testing.
      Specimens for serology will be collected at least bi-monthly and up to monthly thereafter
      through a total study duration of 6, and up to 12, months. SARS-CoV-2 serologic testing for
      IgG antibodies will be conducted in the laboratory of Thomas Denny, MSc, MPhil in the Duke
      Human Vaccine Institute on the campus of Duke University Medical Center using a commercial
      IgG assay (Perkin-Elmer). Samples for serology will be identified only by a unique study
      identification number for each participant. Results of serological testing will be returned
      from the Denny laboratory to the MURDOCK Study investigative team at regular, prespecified
      intervals by secure transfer for incorporation into the RedCap study database. The Denny
      laboratory is CLIA-certified. Any residual serum after SARS-CoV-2 serologic testing will be
      frozen at -80°C and stored for future use in the Duke COVID-19 Biorepository (Pro00105316).

      Return of Results to Participants:

      The investigators will share aggregate results from questionnaires and testing with all
      participants and the public through multiple routes, including email, social media and the
      press and with the scientific community through presentations at scientific meetings and
      publications. The investigators will also provide regular reports on accruing study data to
      NCDHHS. Participants will not be identified individually in these aggregate reports. The
      investigators also will return the results of both COVID-19 PCR testing and serologic testing
      for SARS-CoV-2 antibodies to individual study participants. Individual return of results will
      follow the following principles:

      COVID-19 test results. A standard template for return of negative COVID-19 test results will
      be IRB approved and used to notify participants of their results. If a participant tests
      positive for COVID-19, the participant will be contacted by phone by the study PI or a
      designate to convey the result. General recommendations for participants who test positive
      will be IRB approved. The investigators will also offer these participants a link through
      which they can consider participation in the Duke COVID Community Watch support program
      (Pro00105189). Positive COVID-19 test results will also be reported to the local/state health
      department.

      SARS-CoV-2 serology results. An IRB approved standard template will be used to convey the
      results of SARS-CoV-2 serology to participants. Care will be taken to ensure that
      participants understand what information the results of their SARS-CoV-2 serology conveys
      (and does not convey) in order to avoid any risk of misinterpretation, particularly of
      positive results.

      Selection of Subjects

      List inclusion/exclusion criteria and how subjects will be identified. The MURDOCK NCDHHS
      COVID-19 Prevalence Study will examine COVID-19 prevalence and SARS-CoV-2 antibody prevalence
      in Cabarrus County, NC by leveraging the community-based cohort enrolled in the MURDOCK Study
      Community Registry and Biorepository (MURDOCK Study). The MURDOCK Study is an ongoing
      longitudinal health study operated by the Translational Population Health Research Center in
      the Duke Clinical & Translational Science Institute and approved by the Duke University
      Institutional Review Board (Duke IRB Pro00011196). The MURDOCK Study recruited 12,526
      residents from 20 Zip Codes in the Cabarrus County/Kannapolis region, and currently follows
      10,407 active participants. As part of the MURDOCK Study, all participants provided
      demographic, clinical, and behavioral data via an enrollment questionnaire, were geospatially
      mapped at the street address level, and consented to a yearly follow up questionnaire. They
      also provided consent to be contacted by MURDOCK Study staff up to four times per year to
      consider participation in future research opportunities. A recent protocol communication to
      the IRB was approved to allow additional contacts for high priority COVID-19 research studies
      (Pro00011196-SE-45.0). Our study population for this protocol will include approximately 7200
      active MURDOCK Study participants who currently reside in North Carolina and have a valid
      email address on file. The active study participants who receive a recruitment email and
      consent to participate (estimated 20%) will have the opportunity to declare their interest in
      testing and from among those 300-500 will be randomly selected to participate in the testing.
      The anticipated number to enroll is set at 1,000 but may be adjusted up based on response
      rate.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: Estimate the prevalence of COVID-19 infection based on responses to questionnaire items on symptoms and practices using a biweekly electronic survey.
time frame: 6 months
description: RedCap link will be sent to participants electronically and they will complete and submit the questionnaire.
measure: Assess perceptions, concerns, and practices related to the COVID-19 pandemic and mitigation strategies
time frame: 6 months
description: This will be accomplished using the MURDOCK Study Community Registry and Biorepository (Pro00011196) population as a measure of these features in Cabarrus County through a biweekly electronic survey
measure: Estimate of the prevalence of active infection in Cabarrus County.
time frame: 6 months
description: Among respondents to the baseline questionnaire, conduct bi-weekly at home anterior nares swab collection for viral PCR testing for active COVID-19 infection
measure: Estimate of the prevalence of exposure and potential immunity to COVID-19.
time frame: 6 months
description: Among respondents to the baseline questionnaire, conduct bimonthly serologic testing for IgG antibodies to SARS-CoV-2
arm group label: MURDOCK Study Participants with valid email address
description: Randomized for testing: 1.A randomly selected subset of individuals who consent to participate (N~300-500), will be invited to participate in COVID-19 polymerase chain reaction (PCR) viral testing by at-home collection and return of self-administered nasal swabs. Saliva specimens may replace the nasal swab specimen.
2. The same randomly selected subset of individuals who collect at-home samples for COVID-19 PCR testing (N~300-500), will also provide a blood sample for serologic testing for SARS-CoV-2 IgG antibodies.
intervention type: Other
intervention name: COVID-19 PCR and serology testing
description: PCR testing: participate will conduct at-home collection and return of self-administered nasal swabs for COVID-19 polymerase chain reaction (PCR) viral testing. Saliva specimens may replace the nasal swab specimen. Specimens will be collected at baseline and every 2 weeks in conjunction with questionnaire administration.
Serology testing: The same randomized participants will also provide a blood sample for serologic testing for SARS-CoV-2 IgG antibodies. Specimens will be collected by routine venipuncture at the MURDOCK Study office in Kannapolis, NC.Specimens for serology will be collected at baseline approximately 1 month after the first questionnaire and 2 weeks after the first nasal swab collection and COVID-19 PCR testing. Specimens for serology will be collected at least bi-monthly and up to monthly thereafter through a total study duration of 6, and up to 12, months.
arm group label: MURDOCK Study Participants with valid email address
other name: COVID-19 PCR testing
other name: COVID-19 serology testing
Nose Swabs and Plasma
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kristin Newby, MD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No