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

Completed

• Conditions: COVID-19; SARS-CoV2 Infection
• Interventions: Device: Novel point-of-care, semi-quantitative test for SARS-CoV-2 antibodies

• Registration Number: NCT05196932
• Lead Sponsor: University of Maryland, Baltimore

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).

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 Timeline

• Study First Submitted: 2022-01-17
• Study First Submitted QC: 2022-01-17
• Study First Posted: 2022-01-19
• Study Start: 2022-08-31
• Primary Completion: 2023-04-21
• Study Completion: 2023-04-21
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID Card	Novel point-of-care, semi-quantitative test for SARS-CoV-2 antibodies	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Inter-Rater Reliability	6 months	To measure differences in interpretation (scoring) of hemagglutination patterns between study team members.
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
Type of Blood	6 months	The test characteristics of blood obtained by fingerstick will be compared to that of blood obtained by venipuncture.

Trial Locations

Locations (1)

University of Maryland Medical Systems; 🇺🇸 Baltimore, Maryland, United States