COVID-19SnowballNCT04437706
Network-Targeted Strategies for Efficient Community SARS-CoV-2 (COVID-19) Sampling
An observational study of COVID-19 and SARS-CoV 2, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV 2
- How many people
- 602 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2020to 25 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Currently receiving inpatient treatment for COVID-19
- Unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- COVID-19, SARS-CoV 2
- Keywords
- network analysis, contact tracing, respondent driven sampling
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Participants completing COVID-19 testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Active Infection
Number of participants with active COVID-19 infection
Measured: 12 months
Number of Participants with Antibodies Indicating Past Exposure
Number of participants with antibodies indicating past exposure to SARS-CoV-2
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start11 Dec 2020
- Primary completion25 Jul 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana Pasquale, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437706
- Sponsor's protocol ID
- Pro00105430
- Acronym
- Snowball
- Status last verified
- Nov 2021
- First submitted
- 17 Jun 2020
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37379511Pasquale 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.
PubMed 38805519
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Network-Targeted Strategies for Efficient Community SARS-CoV-2 (COVID-19) Sampling
- ClinicalTrials.gov ID
- NCT04437706
- Acronym / sponsor ID
- Snowball / Pro00105430
- Conditions
- COVID-19, SARS-CoV 2
- Keywords
- network analysis, contact tracing, respondent driven sampling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | –Participants completing COVID-19 testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Currently receiving inpatient treatment for COVID-19
- Unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with Active Infection
Time frame: 12 months
Number of participants with active COVID-19 infection
Number of Participants with Antibodies Indicating Past Exposure
Time frame: 12 months
Number of participants with antibodies indicating past exposure to SARS-CoV-2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Results publication: PubMed 37379511Pasquale 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.
- Results publication: PubMed 38805519Pasquale 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana Pasquale, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS-CoV 2, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Active Infection (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04437706, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.