The COVID-19 PUI Reality Check (CPRC) Study

NCT04474288 | Completed

• 1 other identifier: 1613182
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares SARS-CoV-2 immune responses in high pretest probability swab negative hospitalized PUI patients vs. low pretest probability swab negative hospitalized APS (Asymptomatic Persons being Screened) patients to try to understand the appropriateness and safety of clinical decisions made in these patient populations based on swab results.

Conditions

Covid19 Immunology

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 IgG

  Qualitative seroconversion response rates (RR) in NP SARS-CoV-2 PCR swab negative PUI vs. swab negative APS patients will be compared as the primary outcome measurement.

  120 days

Secondary Outcomes (2)

• host immune response

  120 Days

• pathogen protein expression

  120 days

Study Arms (2)

Person Under Investigation (PUI)

PUI's are subjects who were admitted to the hospital with symptoms suspicious for COVID-19.

Diagnostic Test: SARS-CoV-2 antibody testing

Asymptomatic Person under Screening (APS)

APS's are those patients who do NOT meet the criteria to be a suspect COVID- 19 patient but are being tested because they are being admitted, are required for testing by state mandate, or are having a procedure, etc.

Diagnostic Test: SARS-CoV-2 antibody testing

Interventions

SARS-CoV-2 antibody testing DIAGNOSTIC_TEST

venipuncture for SARS-CoV-2 IgG

Asymptomatic Person under Screening (APS); Person Under Investigation (PUI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients who have had pharyngeal testing negative for the presence of COVID-19

You may qualify if:

• Hospitalized patient (PUI or APS) and tested for SARS-CoV-2 by NP PCR swab
• At least one negative SARS-CoV-2 NP PCR swab within 2 wks of hospitalization
• Adult \>/= 18 yrs old
• Patient or LAR provides informed consent
• Patient or LAR agree to follow-up procedures in informed consent form

You may not qualify if:

• Prior reaction to blood drawing considered significant safety issue by study investigator
• Other factor considered significant safety issue by study investigator
• At least one positive SARS-CoV-2 NP PCR swab within 2 wks of hospitalization

Sponsors & Collaborators

• Bassett Healthcare: lead
• Bioreference, Inc: collaborator

Study Sites (1)

Bassett Medical Center

Cooperstown, New York, 13326, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biospecimens will be analyzed to assess antibody levels, RNA analysis, and analysis of other immunological markers. Subjects have the option to allow their specimens to be retained for future designated research.

MeSH Terms

Interventions

COVID-19 Serological Testing

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Serologic Tests; Immunologic Tests; Investigative Techniques; Immunologic Techniques

Study Officials

• Daniel Freilich, MD

  Bassett Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician - hospitalist/infectious disease

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 16, 2020
• Study Start: July 16, 2020
• Primary Completion: July 1, 2021
• Study Completion: February 28, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Locations

US (1)