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

Jill M Kolesar

Overview

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

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.

Study Type

OBSERVATIONAL

Conditions

Covid19 SARS-CoV Infection

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Kentucky

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

PCR Conversion in Exposed Individuals

Determine the average time point at which PCR conversion occurs following exposure.

Time frame: 14 days

Data from ClinicalTrials.gov

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