A Registry Study of COVID-19 Serologic and Virologic Testing to Accelerate Recovery and Transition
Purpose
The co-primary objectives of this study are to: 1. Determine and compare the COVID-19 antibody positivity rate in health care workers and patients without a known COVID-19 infection 2. Determine if PCR negativity for COVID-19 early in quarantine predicts negativity at Day 14 in quarantining individuals
Conditions
- Covid19
- SARS-CoV Infection
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Individuals (health-care workers and patients) undergoing standard of care assessment of SARS-CoV-2 serology testing - Individuals with a COVID-19 exposure requiring quarantine who are asymptomatic and who will receive standard of care SARS-CoV-2 PCR testing. - Able to understand and sign the Informed Consent and Research Authorization From.
Exclusion Criteria
- Prisoners - Patients with psychiatric illness that would limit compliance - Patients with social situations that would limit compliance
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Health Care Workers | Health-care workers undergoing standard of care assessment of SARS-CoV-2 serology testing at UKHC. | |
| Eligible Patients | Patients undergoing standard of care assessment of SARS-CoV-2 serology testing at UKHC. | |
| Quarantining Individuals | Individuals with a COVID-19 exposure requiring quarantine who are asymptomatic and who will receive standard of care SARS-CoV-2 PCR testing. |
Recruiting Locations
More Details
- NCT ID
- NCT04573634
- Status
- Withdrawn
- Sponsor
- Jill M Kolesar
Detailed Description
This is a prospective cohort study designed to identify the prevalence of IgG antibodies to SARS CoV-2 as well as to assess risk factors for IgG positivity. It will compare rates of positivity and risk factors among healthcare workers and non-healthcare workers and assess the ability of PCR negativity at day 3 or 4, 5, 7, or 10 to predict negativity on day 14 in individuals quarantining after a COVID exposure. In addition to having a standard of care clinical antibody test, both healthcare workers, quarantining individuals, and patients will be asked to fill out a survey to assess risk factors for COVID infection and provide a research blood sample. Quarantining individuals will also have standard of care PCR testing on days 3 or 4, 5, 7, 10, and 14 of the quarantine period. Collected blood samples will be used to assess for the presence of neutralizing antibodies and measure antibodies with a research test. An annual blood specimen and survey will be collected from each study participant for up to 2 years total after study entry.