Clinical trial NCT04573634: A Registry Study of COVID-19 Serologic and Virologic Testing to Accelerate Recovery and Transition
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Covid19
SARS-CoV Infection
Keywords: prevalance
risk-factor
population
Kentucky
antibody
SARS CoV-2
seroconversion
physical distancing
PCR
quarantine
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief 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

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.

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

Primary outcomes:
measure: Prevalence of COVID-19
timeFrame: 2 years
Secondary outcomes:
measure: PCR Conversion in Exposed Individuals
timeFrame: 14 days
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Jill Kolesar, PharmD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky
name: Derek Forster, MD
role: PRINCIPAL_INVESTIGATOR
References: