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

Jill M Kolesar

Status: Withdrawn

Conditions: SARS-CoV Infection; Covid19

Study type: Observational

Funder types: Other

Identifiers

NCT04573634

PHARM-20-COVID19-START

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

0 participants in 3 patient groups

Health Care Workers

Description:

Health-care workers undergoing standard of care assessment of SARS-CoV-2 serology testing at UKHC.

Eligible Patients

Description:

Patients undergoing standard of care assessment of SARS-CoV-2 serology testing at UKHC.

Quarantining Individuals

Description:

Individuals with a COVID-19 exposure requiring quarantine who are asymptomatic and who will receive standard of care SARS-CoV-2 PCR testing.