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

NCT04424004 | Completed

• 1 other identifier: Pro00105703
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID 19

Outcome Measures

Primary Outcomes (4)

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

  RedCap link will be sent to participants electronically and they will complete and submit the questionnaire.

  6 months

• Assess perceptions, concerns, and practices related to the COVID-19 pandemic and mitigation strategies

  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

  6 months

• Estimate of the prevalence of active infection in Cabarrus County.

  Among respondents to the baseline questionnaire, conduct bi-weekly at home anterior nares swab collection for viral PCR testing for active COVID-19 infection

  6 months

• Estimate of the prevalence of exposure and potential immunity to COVID-19.

  Among respondents to the baseline questionnaire, conduct bimonthly serologic testing for IgG antibodies to SARS-CoV-2

  6 months

Study Arms (1)

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

Interventions

COVID-19 PCR and serology testing OTHER

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.

Also known as: COVID-19 PCR testing, COVID-19 serology testing

MURDOCK Study Participants with valid email address

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• North Carolina Department of Health and Human Services: collaborator

Study Sites (1)

Duke CTSI Translational Population Health Office

Kannapolis, North Carolina, 28081, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nose Swabs and Plasma

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Nucleic Acid Testing; COVID-19 Serological Testing

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Serologic Tests; Immunologic Tests; Immunologic Techniques

Study Officials

• Kristin Newby, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 9, 2020
• Study Start: June 9, 2020
• Primary Completion: December 2, 2021
• Study Completion: December 2, 2021
• Last Updated: February 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)