ScreenNC, a Study to Determine the Number of Asymptomatic Individuals Who Have Antibodies to the Virus That Causes COVID-19
ScreenNC: A Study to Determine the Number of Asymptomatic Individuals Who Have Antibodies to the SARS-CoV-2 Infection
1 other identifier
observational
6,313
1 country
1
Brief Summary
Purpose: To determine the number of asymptomatic individuals who have antibodies to SARS-CoV-2, the virus which causes COVID-19
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2020
CompletedStudy Start
First participant enrolled
April 28, 2020
CompletedFirst Posted
Study publicly available on registry
April 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedJanuary 9, 2023
January 1, 2022
1.8 years
April 27, 2020
January 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Asymptomatic patients with an IgG response from SARS-CoV-2 infection.
Presence or absence of IgG antibodies to SARS-CoV2
at enrollment
Secondary Outcomes (1)
Percentage of Asymptomatic patients with viral presence of SARS-CoV-2 infection.
at enrollment
Study Arms (1)
Serum Antibodies
Blood samples to be obtained assess for IgG antibodies against SARS-CoV2
Interventions
Swabs will be collected to assess for COVID-19 if PPE supplies allow.
Eligibility Criteria
Patients seen at UNC Outpatient clinics who are asymptomatic for COVID-19 infection
You may qualify if:
- Individuals aged 18-99 who arrive at any participating UNC Healthcare clinic for care and who have a medical record in UNC EPIC.
- Patients may be included if they have completed the quarantine as recommended by the CDC and at least 4 weeks since the initial positive COVID-19 NP test.
You may not qualify if:
- Any individual arriving at any participating UNC Healthcare clinic for diagnosis or treatment of respiratory symptoms meeting the following COVID-19 clinical evaluation criteria:
- Developed non-allergy respiratory symptoms of cough or shortness of breath in the past 7 days
- AND
- Meet ONE OR MORE of these criteria
- Had close contact (within 6 feet for 10 or more minutes) with a person diagnosed with COVID-19
- Works in a healthcare setting
- Is pregnant or postpartum within 2 weeks of delivery
- Is morbidly obese: BMI = 40 or 100 pounds over ideal body weight
- Diabetes mellitus
- Immunosuppression, including caused by medications or by HIV infection
- Pulmonary disease, including asthma
- Cardiovascular disease
- Hypertensive disease
- Renal disease
- Hepatic disease
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, 27599, United States
Biospecimen
Blood; virus from nasal or oral swab
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David B Peden, MD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2020
First Posted
April 29, 2020
Study Start
April 28, 2020
Primary Completion
February 24, 2022
Study Completion
February 28, 2022
Last Updated
January 9, 2023
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share