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Network-Targeted Strategies for Efficient Community SARS-CoV-2 (COVID-19) Sampling (Snowball)

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ClinicalTrials.gov Identifier: NCT04437706
Recruitment Status : Enrolling by invitation
First Posted : June 18, 2020
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease
COVID-19 SARS-CoV 2

Detailed Description:

Purpose and objective: The purpose of this study is to use community sampling to detect active, undiagnosed COVID-19 cases and/or determine the spread or distribution of active infection. The objective is to use a network targeted sampling design to direct testing to yield a higher proportion of results which indicate active infection and possibly differentiating between venues or communities where transmission is active and undiagnosed.

Study activities: A person who tests positive for COVID-19 will be given a set of "tokens" to give to contacts that will entitle these contacts to make an appointment to receive a test for COVID-19.

Population groups: The population group will include people with index cases of COVID-19 and their contacts for the past 14 days. As these contacts are tested and receive positive results, they will be given tokens to hand out to their contacts over the past 14 days. The network of positive cases will "blossom" to reveal community transmission and asymptomatic cases, thus giving researchers an indication of disease prevalence.

Data analysis: At the completion of each epoch and at the end of the study, we will scale the social networks up and conduct network analysis using SAS and the igraph package in R. These analyses will be applied in an ongoing manner to guide selection of seeds in subsequent epochs to ensure representativeness and to guide selection of alters to encourage longer referral chain lengths.

Risk/safety issues: The primary risks include discomfort from the nasal swab and risks from the venous blood draw used in testing and the potential loss of confidentiality. All efforts will be made to securely manage the data to ensure participant confidentiality.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Network-Targeted Strategies for Efficient Community SARS-CoV-2 (COVID-19) Sampling
Actual Study Start Date : December 11, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Group/Cohort
Participants
Participants completing COVID-19 testing



Primary Outcome Measures :
  1. Number of Participants with Active Infection [ Time Frame: 12 months ]
    Number of participants with active COVID-19 infection

  2. Number of Participants with Antibodies Indicating Past Exposure [ Time Frame: 12 months ]
    Number of participants with antibodies indicating past exposure to SARS-CoV-2


Biospecimen Retention:   Samples With DNA
Blood and pharyngeal swabs


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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): NCT04437706


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Erich Huang, MD, PhD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04437706    
Other Study ID Numbers: Pro00105430
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
network analysis
contact tracing
respondent driven sampling
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases