The COVID-19 PUI Reality Check (CPRC) Study (CPRC)

SARS-CoV-2 Specific Immune Responses in Hospitalized Persons Under Investigation (PUIs) With Negative Nasopharyngeal PCR Swabs - The COVID-19 PUI Reality Check (CPRC) Study

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.

Study Overview

• Status: Completed
• Conditions: Covid19 Immunology
• Intervention / Treatment: Diagnostic test: SARS-CoV-2 antibody testing

Detailed Description

This is essentially a two phase blood drawing and immune assays study. Phase 1 will be a single convalescent timing immune retrospective study; phase 2 will include paired samples to increase immune response accuracy in a prospective study. In phase 1, hospitalized PUI and APS patients with negative nasopharyngeal PCR swabs selected by Epic query of Bassett records, will be contacted by telephone (or in person if hospitalized), offered enrollment in the study, and provided informed consent if they're interested. For consented/enrolled patients, routine baseline demographic and clinical data will be obtained by interview (in person or telephone) and/or EMR (Epic) review. These data will be needed to describe baseline characteristics and to assess for predictors of serologic conversion and other immune responses in the two study populations. Up to two to three visits will be required for brief interviews, record review, and blood draws. Phase 1 patients will have visits/blood draws on days 14 and 28 after hospitalization or at 28 days after hospitalization only (-3 days, +60 days) if patients are beyond day 14 at the time of study initiation; phase 2 patients will have visits/blood draws aiming for days 0, 14 (+/- 3 days), and 28 (+/- 3 days) after hospital admission.

Blood will be drawn for SARS-CoV-2 specific immune assays (below). For phase 1 patients, baseline immune assays will not be available as blood is not available for them; thus, for many phase 1 patients, only one of the day 14 and 28 immune assays will be practical. In Phase 2, these procedures will be the same except baseline blood draws will be possible at hospitalization as well. Thus, blood drawing will be at target days 0, 14, and 28 for phase 2 patients. Short interviews at days 14 and 28 will be conducted to assess for new COVID-19 compatible illnesses that may confound immune response results.

Up to 27.5 ml of blood will be required at each timepoint (PAXgene tube 2.5 ml, heparinized tube 10 ml, EDTA tube 10 ml, SST tube 5 ml). Total blood drawing will be up to 55 ml in phase 1 patients and up to 82.5 ml in phase 2 patients. Serologic and additional immune assays will be conducted on blood drawn at these time points to assess for SARS-CoV-2 specific immune responses (see below).

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• United States
  • New York
    • Cooperstown, New York, United States, 13326
      • Bassett Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion criteria:

• 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

Exclusion criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; venipuncture for SARS-CoV-2 IgG
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; venipuncture for SARS-CoV-2 IgG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
host immune response	mRNA gene expression by RNAseq from whole blood collected into PAXGene RNA tubes	120 Days
pathogen protein expression	identification of a signature of differentially expressed host genes or antigen/epitope specific antibody or cellular responses.	120 days

Collaborators and Investigators

• Sponsor: Bassett Healthcare
• Collaborators: Bioreference, Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 16, 2020
• Primary Completion (ACTUAL): July 1, 2021
• Study Completion (ACTUAL): February 28, 2022

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (ACTUAL): July 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: 1613182

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No