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
Brief Summary

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

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.

Withdrawn
COVID19
SARS-CoV Infection
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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

University of Kentucky
Lexington, Kentucky, United States

Jill M Kolesar
NCT Number
Keywords
prevalance
risk-factor
population
Kentucky
antibody
SARS CoV-2
Seroconversion
physical distancing
PCR
quarantine
MeSH Terms
COVID-19
Severe Acute Respiratory Syndrome