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

NCT04573634 | Withdrawn DMC

• 1 other identifier: PHARM-20-COVID19-START
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The co-primary objectives of this study are to:

1. 1.Determine and compare the COVID-19 antibody positivity rate in health care workers and patients without a known COVID-19 infection
2. 2.Determine if PCR negativity for COVID-19 early in quarantine predicts negativity at Day 14 in quarantining individuals

Conditions

Covid19; SARS-CoV Infection

Keywords

prevalance; risk-factor; population; Kentucky; antibody; SARS CoV-2; seroconversion; physical distancing; PCR; quarantine

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• PCR Conversion in Exposed Individuals

  14 days

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• Prisoners
• Patients with psychiatric illness that would limit compliance
• Patients with social situations that would limit compliance

Sponsors & Collaborators

• Jill M Kolesar: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasal swabs, whole blood, serum, plasma and buffy coat

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome; HIV Seropositivity

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jill Kolesar, PharmD, MS

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Derek Forster, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 5, 2020
• Study Start: May 15, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)