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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04334876
Recruitment Status : Completed
First Posted : April 6, 2020
Results First Posted : September 16, 2021
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Courtney Rowan, Indiana University

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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Diagnostic Test: SARS-CoV-2 IgG Antibody Testing Kit Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 571 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Rapid SARS-CoV-2 IgG Antibody Testing in High Risk Healthcare Workers and Candidacy for Convalescent Plasma Therapy/Prophylaxis
Actual Study Start Date : April 1, 2020
Actual Primary Completion Date : November 1, 2020
Actual Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
High Risk Healthcare Workers
At home, finger prick, antibody test.
Diagnostic Test: SARS-CoV-2 IgG Antibody Testing Kit
A, finger prick, at home test for SARS-CoV-2 IgG Antibodies.
Other Name: Ray Biotech




Primary Outcome Measures :
  1. Number of Participant Health Care Workers With a Positive Rapid, At-home, Point-of-care (POC) SARS-CoV2 IgG Antibody Test. [ Time Frame: 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 ]
    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.


Secondary Outcome Measures :
  1. Number of Healthcare Workers Willing to be Convalescent Plasma Donors if Appropriate [ Time Frame: Enrollment open from April 2020-January 2021. Subjects completed survey at time of submitting the results of the at home POC test. Survey questioned willingness to donate plasma if found to have antibodies to SARS Co-V2. ]
    To identify possible candidates for convalescent plasma donation for therapy/prophylaxis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. 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)

Exclusion Criteria:

1. Previously tested for COVID-19


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04334876


Locations
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United States, Indiana
Indiana University Health Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Courtney Rowan, MD Indiana University
  Study Documents (Full-Text)

Documents provided by Courtney Rowan, Indiana University:
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Responsible Party: Courtney Rowan, MD, Indiana University
ClinicalTrials.gov Identifier: NCT04334876    
Other Study ID Numbers: 2003973826
First Posted: April 6, 2020    Key Record Dates
Results First Posted: September 16, 2021
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Antibodies
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs