A Registry Study of COVID-19 Serologic and Virologic Testing to Accelerate Recovery and Transition

Study Overview
=================
Brief Summary
-----------------
The co-primary objectives of this study are to: Determine and compare the COVID-19 antibody positivity rate in health care workers and patients without a known COVID-19 infection Determine if PCR negativity for COVID-19 early in quarantine predicts negativity at Day 14 in quarantining individuals

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.

Official Title
-----------------
A Registry Study of COVID-19 Serologic and Virologic Testing to Accelerate Recovery and Transition (START) - Assessment of COVID19 Penetrance in HCW and Non HCW in Kentucky

Conditions
-----------------
Covid19, SARS-CoV Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Health Care Workers<br>Health-care workers undergoing standard of care assessment of SARS-CoV-2 serology testing at UKHC. | |
| Eligible Patients<br>Patients undergoing standard of care assessment of SARS-CoV-2 serology testing at UKHC. | |
| Quarantining Individuals<br>Individuals with a COVID-19 exposure requiring quarantine who are asymptomatic and who will receive standard of care SARS-CoV-2 PCR testing. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of COVID-19 | Proportion of people with IgG antibodies against SARS CoV-2 using a standard of care, Clinical Laboratory Improvement Amendments (CLIA), IgG antibody test. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCR Conversion in Exposed Individuals | Determine the average time point at which PCR conversion occurs following exposure. | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prevalance, risk-factor, population, Kentucky, antibody, SARS CoV-2, seroconversion, physical distancing, PCR, quarantine