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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04573634

Acronym

START

Enrollment

Registered

2020-10-05

Start date

2020-05-15

Completion date

2023-12-31

Last updated

2022-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, SARS-CoV Infection

Keywords

prevalance, risk-factor, population, Kentucky, antibody, SARS CoV-2, seroconversion, physical distancing, PCR, quarantine

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results