A Registry Study of COVID-19 Serologic and Virologic Test... | NCT04573634

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

NCT04573634

Sponsor

Jill M Kolesar

Status

Withdrawn

Last Update Posted

Sep 14, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Covid19
SARS-CoV Infection

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low accrual

Expanded Access Info

Start Date

May 15, 2020Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Sep 30, 2020

First Submission Date that Met QC Criteria

Sep 30, 2020

First Posted Date

Oct 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2022

Last Update Posted Date

Sep 14, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jill Kolesar, PharmD, MS	University of Kentucky	Principal Investigator
Derek Forster, MD	University of Kentucky	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kentucky		Lexington	Kentucky	40536	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D045169	Severe Acute Respiratory Syndrome
D006679	HIV Seropositivity

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided