NCT04437706

Brief Summary

The primary objective is to use "network targeted sampling design" to detect active and/or undiagnosed cases of COVID-19 in the community and determine the spread or distribution of 1) active infection, and 2) past exposure. The hypothesis is that there are many undiagnosed and/or asymptomatic people in the community who may be unknowingly spreading the virus or have been exposed and have antibodies. We propose to implement respondent-driven sampling (RDS) which leverages effort on the part of seed or index cases to recruit contacts for participation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
602

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

December 11, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2022

Completed
Last Updated

June 6, 2024

Status Verified

November 1, 2021

Enrollment Period

1.6 years

First QC Date

June 17, 2020

Last Update Submit

June 4, 2024

Conditions

Keywords

network analysiscontact tracingrespondent driven sampling

Outcome Measures

Primary Outcomes (2)

  • Number of Participants with Active Infection

    Number of participants with active COVID-19 infection

    12 months

  • Number of Participants with Antibodies Indicating Past Exposure

    Number of participants with antibodies indicating past exposure to SARS-CoV-2

    12 months

Study Arms (1)

Participants

Participants completing COVID-19 testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults (18+ years) in the community who have tested positive for COVID-19 or have been in close contact with someone who is known to be COVID-19 positive

You may qualify if:

  • Positive COVID-19 test result -or- receipt of a coupon from a previous study participant
  • Resident of Durham County (for seed participant only)
  • Willing to undergo COVID-19 test nasopharyngeal swab for RT-PCR testing and blood draw for COVID-19 antibody testing
  • Age 18+
  • Speak and understand English

You may not qualify if:

  • Currently receiving inpatient treatment for COVID-19
  • Unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Margaret Pendzich

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

  • Pasquale DK, Welsh W, Olson A, Yacoub M, Moody J, Barajas Gomez BA, Bentley-Edwards KL, McCall J, Solis-Guzman ML, Dunn JP, Woods CW, Petzold EA, Bowie AC, Singh K, Huang ES. Scalable Strategies to Increase Efficiency and Augment Public Health Activities During Epidemic Peaks. J Public Health Manag Pract. 2023 Nov-Dec 01;29(6):863-873. doi: 10.1097/PHH.0000000000001780. Epub 2023 Jun 28.

  • Pasquale DK, Welsh W, Bentley-Edwards KL, Olson A, Wellons MC, Moody J. Homophily and social mixing in a small community: Implications for infectious disease transmission. PLoS One. 2024 May 28;19(5):e0303677. doi: 10.1371/journal.pone.0303677. eCollection 2024.

Biospecimen

Retention: SAMPLES WITH DNA

Blood and pharyngeal swabs

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Dana Pasquale, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 18, 2020

Study Start

December 11, 2020

Primary Completion

July 25, 2022

Study Completion

July 25, 2022

Last Updated

June 6, 2024

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations