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WithdrawnNCT04573634STARTUpdated Sep 14, 2022

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

An observational study in Covid19 and SARS-CoV Infection, sponsored by Jill M Kolesar. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-14.

Sponsored by Jill M Kolesar · Observational

Why this study was withdrawn
Low accrual
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

  • Covid19
  • SARS-CoV Infection

Keywords

  • prevalance
  • risk-factor
  • population
  • Kentucky
  • antibody
  • SARS CoV-2
  • seroconversion
  • physical distancing
  • PCR
  • quarantine
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

Browse COVID-19 studies →

Lead sponsor

This is the only study on the registry with Jill M Kolesar as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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).

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

Exclusion Criteria:

  • Prisoners
  • Patients with psychiatric illness that would limit compliance
  • Patients with social situations that would limit compliance
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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

  1. PCR Conversion in Exposed Individuals

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

    Time frame: 14 days

07

Study locations

1 site
  • University of Kentucky
    Lexington, Kentucky 40536, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04573634
Lead sponsor
Jill M Kolesar
Responsible party
Jill M Kolesar (Professor, University of Kentucky) — Sponsor-investigator
First posted
Oct 5, 2020
Start date
May 15, 2020
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Sep 14, 2022

Study contacts

Jill Kolesar, PharmD, MS
principal investigator · University of Kentucky
Derek Forster, MD
principal investigator · University of Kentucky

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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