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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-31

Study Completion Date

2023-04-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

ANTIBODY BASED TESTS FOR SARSCoV-2 COVID-19) - Evaluation of Patients and Healthcare Providers in the Confines of Healthcare Settings

NCT04352764

Covid19

UNKNOWN

COVID-19 Immunity Assessment

NCT05080231

COVID-19

COMPLETED

Evaluation of Rapid Diagnostic Solutions, Serological and Molecular Tests for COVID-19

NCT04405492

SARS-CoV 2 COVID-19

UNKNOWN NA

Healthy Volunteer COVID-19 Antibody Testing Study

NCT04529460

Covid19

WITHDRAWN

Rapid SARS-CoV-2 IgG Antibody Testing in High Risk Healthcare Workers

NCT04334876

SARS-CoV-2

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 SARS-CoV2 Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Novel point-of-care, semi-quantitative test for SARS-CoV-2 antibodies

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Covid Card

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes