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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-15

Study Completion Date

2023-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Covid19 SARS-CoV Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Health Care Workers

Health-care workers undergoing standard of care assessment of SARS-CoV-2 serology testing at UKHC.

No interventions assigned to this group

Eligible Patients

Patients undergoing standard of care assessment of SARS-CoV-2 serology testing at UKHC.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.