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

Sponsor

Jill M Kolesar (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04573634

Collaborator

(none)

332

Enrollment

Location

43.5

Anticipated Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Covid19 SARS-CoV Infection

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.

Study Design

Study Type:

Observational

Actual Enrollment :

332 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

May 15, 2020

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Health Care Workers Health-care workers undergoing standard of care assessment of SARS-CoV-2 serology testing at UKHC.
Eligible Patients Patients undergoing standard of care assessment of SARS-CoV-2 serology testing at UKHC.
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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

PCR Conversion in Exposed Individuals [14 days]
Determine the average time point at which PCR conversion occurs following exposure.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.