Rapid SARS-CoV-2 IgG Antibody Testing in High Risk Healthcare Workers (COVID-Antibody)
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ClinicalTrials.gov Identifier: NCT04334876 |
Recruitment Status :
Completed
First Posted : April 6, 2020
Results First Posted : September 16, 2021
Last Update Posted : September 16, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
SARS-CoV-2 | Diagnostic Test: SARS-CoV-2 IgG Antibody Testing Kit | Not Applicable |

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 |

Arm | Intervention/treatment |
---|---|
High Risk Healthcare Workers
At home, finger prick, antibody test.
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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 |
- 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.
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
Exclusion Criteria:
1. Previously tested for COVID-19

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
United States, Indiana | |
Indiana University Health Hospital | |
Indianapolis, Indiana, United States, 46202 |
Principal Investigator: | Courtney Rowan, MD | Indiana University |
Documents provided by Courtney Rowan, Indiana University:
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Antibodies Immunoglobulin G Immunologic Factors Physiological Effects of Drugs |