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:
- 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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Kontakter og lokationer
Studiesteder
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536
- University Of Kentucky
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Health Care Workers
Health-care workers undergoing standard of care assessment of SARS-CoV-2 serology testing at UKHC.
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Eligible Patients
Patients undergoing standard of care assessment of SARS-CoV-2 serology testing at UKHC.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Prevalence of COVID-19
Tidsramme: 2 years
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Proportion of people with IgG antibodies against SARS CoV-2 using a standard of care, Clinical Laboratory Improvement Amendments (CLIA), IgG antibody test.
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2 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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PCR Conversion in Exposed Individuals
Tidsramme: 14 days
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Determine the average time point at which PCR conversion occurs following exposure.
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14 days
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jill Kolesar, PharmD, MS, University Of Kentucky
- Ledende efterforsker: Derek Forster, MD, University Of Kentucky
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PHARM-20-COVID19-START
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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