Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

MURDOCK Cabarrus County COVID-19 Prevalence and Immunity (C3PI) Study (C3PI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04424004
Recruitment Status : Active, not recruiting
First Posted : June 9, 2020
Last Update Posted : November 17, 2020
Sponsor:
Collaborator:
North Carolina Department of Health and Human Services
Information provided by (Responsible Party):
Duke University

Brief Summary:

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.

Condition or disease Intervention/treatment
COVID 19 Other: COVID-19 PCR and serology testing

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: MURDOCK Cabarrus County COVID-19 Prevalence and Immunity (C3PI) Study
Actual Study Start Date : June 9, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Group/Cohort Intervention/treatment
MURDOCK Study Participants with valid email address

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.

Other: COVID-19 PCR and serology testing
  1. 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.
  2. 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.
Other Names:
  • COVID-19 PCR testing
  • COVID-19 serology testing




Primary Outcome Measures :
  1. 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 ]
    RedCap link will be sent to participants electronically and they will complete and submit the questionnaire.

  2. Assess perceptions, concerns, and practices related to the COVID-19 pandemic and mitigation strategies [ Time Frame: 6 months ]
    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

  3. Estimate of the prevalence of active infection in Cabarrus County. [ Time Frame: 6 months ]
    Among respondents to the baseline questionnaire, conduct bi-weekly at home anterior nares swab collection for viral PCR testing for active COVID-19 infection

  4. Estimate of the prevalence of exposure and potential immunity to COVID-19. [ Time Frame: 6 months ]
    Among respondents to the baseline questionnaire, conduct bimonthly serologic testing for IgG antibodies to SARS-CoV-2


Biospecimen Retention:   Samples With DNA
Nose Swabs and Plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
ALL active MURDOCK study participants who currently reside in North Carolina and have a valid email address. The demographics of the MURDOCK study cohort are representative of the population in Cabarrus County and North Carolina.
Criteria

Inclusion Criteria:

  • MURDOCK Study participants ( Pro00011196) currently residing in North Carolina who have a valid email address on file.

Exclusion Criteria:

  • MURDOCK Study participants ( Pro00011196) currently not residing in North Carolina
  • MURDOCK Study participants without a valid email address on file.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04424004


Locations
Layout table for location information
United States, North Carolina
Duke CTSI Translational Population Health Office
Kannapolis, North Carolina, United States, 28081
Sponsors and Collaborators
Duke University
North Carolina Department of Health and Human Services
Investigators
Layout table for investigator information
Principal Investigator: Kristin Newby, MD Duke University
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04424004    
Other Study ID Numbers: Pro00105703
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No