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

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

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

Study Overview

• Status: Withdrawn
• Conditions: 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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals (health-care workers and patients) undergoing standard of care assessment of SARS-CoV-2 serology testing at the University of Kentucky or individuals with a COVID-19 exposure requiring quarantine who are asymptomatic and who will receive standard of care testing. Notably, these individuals may not have active COVID infection; they will be assessed for antibodies which is evidence of a prior, asymptomatic COVID infection or infection associated with a known exposure as diagnosed by polymerase chain reaction (PCR).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jill M Kolesar
• Investigators: Principal Investigator: Jill Kolesar, PharmD, MS, University of Kentucky; Principal Investigator: Derek Forster, MD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 9, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: antibody; PCR; seroconversion; SARS CoV-2; population; quarantine; Kentucky; prevalance; risk-factor; physical distancing
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19
• Other Study ID Numbers: PHARM-20-COVID19-START

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No