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

Covid19 Clinical Trial

— START  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04573634
• Other study ID #: PHARM-20-COVID19-START
• Status: Withdrawn
• Start date: May 15, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Jill M Kolesar

Country where clinical trial is conducted

United States, 

Outcome

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