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
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
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|