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

NCT04334876 | Completed Results DMC FDA Device

• 1 other identifier: 2003973826
• Study Type: interventional
• Target: 571
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to validate the use of a rapid, at home, point-of-care (POC) SARS-CoV-2 IgG antibody test in high risk healthcare workers. Additionally, we would like to evaluate the incidence of seroconversion in this high-risk population and to identify possible candidates for convalescent plasma donation for therapy/prophylaxis.

Conditions

SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Number of Participant Health Care Workers With a Positive Rapid, At-home, Point-of-care (POC) SARS-CoV2 IgG Antibody Test.

  To determine the number of high risk health care workers with a positive SARS CoV2 IgG on a rapid, at home, self-administered, point-of-care (POC) test. Positive POC tests were then assessed for confirmation using a serum antibody test.

  Subjects self-administered the at home POC test and self-reported at their convenience. Testing/reported took approx 15min. Follow up at home testing allowed q 3 weeks post-reporting for a total of 3 at-home tests possible

Secondary Outcomes (1)

• Number of Healthcare Workers Willing to be Convalescent Plasma Donors if Appropriate

  Enrollment open from April 2020-January 2021. Subjects completed survey at time of submitting the results of the at home POC test, approximately 15mins.. Survey questioned willingness to donate plasma if found to have antibodies to SARS Co-V2.

Study Arms (1)

High Risk Healthcare Workers

OTHER

At home, finger prick, antibody test.

Diagnostic Test: SARS-CoV-2 IgG Antibody Testing Kit

Interventions

SARS-CoV-2 IgG Antibody Testing Kit DIAGNOSTIC_TEST

A, finger prick, at home test for SARS-CoV-2 IgG Antibodies.

Also known as: Ray Biotech

High Risk Healthcare Workers

Eligibility Criteria

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

You may qualify if:

• High risk healthcare workers, prioritizing those who are exposed to aerosol generating procedures (physicians and respiratory therapist) working in the emergency room or intensive care units at Indiana University Health or IU school of Medicine affiliated facilities. A second tier of prioritization, to be approached if testing capacity remains after the initial testing phase, will be nurses working these same areas
• Health care workers who are currently out sick or quarantined due to possible/known exposure to COVID-19 and whose physician confirms that a negative test would allow their return to work are also eligible for testing (Subjects in this group may begin study procedures and be registered once they reach the end of their quarantine period)

You may not qualify if:

• \. Previously tested for COVID-19

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Health Hospital

Indianapolis, Indiana, 46202, United States

Location

Results Point of Contact

• Title: Courtney Rowan
• Organization: Indiana University

coujohns@iu.edu

317-944-7065

Study Officials

• Courtney Rowan, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 6, 2020
• Study Start: April 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: January 1, 2021
• Last Updated: April 26, 2023
• Results First Posted: September 16, 2021

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)