COVID Card Pilot Study to Detect Antibodies to SARS-CoV-2

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05196932
Collaborator
(none)
50
1
16

Study Details

Study Description

Brief Summary

This study aims to investigate the clinical performance characteristics of the novel point-of-care, semi-quantitative test for SARS-CoV-2 in the Emergency Department compared to the gold standard (ELISA).

Condition or Disease Intervention/Treatment Phase
  • Device: Novel point-of-care, semi-quantitative test for SARS-CoV-2 antibodies
N/A

Detailed Description

A prospective, non-blinded, non-randomized trial will be conducted at the Adult Emergency Department at the University of Maryland Medical Center and Adult Urgent Care Center, which is managed by the Department of Emergency Medicine, located in Baltimore, Maryland.

Patients meeting eligibility criteria and who have signed the research informed consent will be enrolled in this study. Subject data collected will include demographic information and past medical history. Upon enrollment into the study, a study team member will obtain a fingerstick blood sample and a sample of blood obtained during usual care venipuncture. Both fingerstick blood and blood from venipuncture will be run on the point-of-care, semi-quantitative test. The test should be expected to result within minutes after the blood sample is added to the agglutinin. An additional tube of blood will be obtained and sent to the local central laboratory for quantitative serum SARS-CoV-2 antibody testing.

Additional data will be collected on the reported or documented COVID-19 immunization status and reported or documented history of prior COVID-19 infection.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Pilot Study Investigating the Clinical Performance of a Novel, Point-of-care, Semi-quantitative Test for SARS-CoV-2 Antibodies in Patients Vaccinated Against COVID-19
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: COVID Card

Enrolled patients will receive antibody testing using both: 1) point-of-care, semi-quantitative SARS-CoV-2 antibodies test, 2) SARS-CoV-2 central laboratory antibodies test

Device: Novel point-of-care, semi-quantitative test for SARS-CoV-2 antibodies
A drop of blood obtained by both finger-prick and venipuncture will be placed on the test card, which has been activated by the addition of diluent. Visual clumping of red blood cells (RBCs) will be seen within minutes if SARS-CoV-2 antibodies are present. Additionally, the COVID card is semi-quantitative, meaning that the yielded hemagglutination pattern will correlate with the concentration of antibodies in the serum. A research team member will be present at bedside to provide their interpretation based on an established visual agglutination scoring system.
Other Names:
  • Covid Card
  • Outcome Measures

    Primary Outcome Measures

    1. Clinical Performance [6 months]

      To measure the diagnostic sensitivity, specificity, and accuracy compared to the gold standard central laboratory SARS-CoV-2 antibody test.

    Secondary Outcome Measures

    1. Past Medical Conditions [6 months]

      To measure the diagnostic sensitivity, specificity, and accuracy compared to the gold standard central laboratory SARS-CoV-2 antibody test relative to patient past medical conditions

    2. Time Since Vaccination [6 months]

      To measure the diagnostic sensitivity, specificity, and accuracy compared to the gold standard central laboratory SARS-CoV-2 antibody test relative to the time since vaccination

    3. Inter-Rater Reliability [6 months]

      To measure differences in interpretation (scoring) of hemagglutination patterns between study team members.

    4. Type of Blood [6 months]

      The test characteristics of blood obtained by fingerstick will be compared to that of blood obtained by venipuncture.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Adult (age > 18 years) emergency department patients

    2. ED workup includes blood testing

    3. Confirmed history of vaccination against SARS-CoV-2

    Exclusion Criteria:
    1. Known to be pregnant at the time of evaluation

    2. Incarcerated at the time of evaluation

    3. Requires the use of an interpreter

    4. Patient is considered immunocompromised or has any other condition that the investigator feels makes the patient unsuitable for study inclusion.

    5. Has any other condition that the investigator feels makes the patient unsuitable for study inclusion

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Maryland, Baltimore

    Investigators

    • Principal Investigator: Richard G Wilkerson, MD, University of Maryland School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Richard Gentry Wilkerson, Associate Professor, University of Maryland, Baltimore
    ClinicalTrials.gov Identifier:
    NCT05196932
    Other Study ID Numbers:
    • HP-00099032
    First Posted:
    Jan 19, 2022
    Last Update Posted:
    Jul 18, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 18, 2022