N/A
N=571
Rapid SARS-CoV-2 IgG Antibody Testing in High Risk Healthcare Workers
SARS-CoV-2
Bottom Line
View on ClinicalTrials.gov: NCT04334876 ↗Enrolled (actual)
571
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Number of Participant Health Care Workers With a Positive Rapid, At-home, Point-of-care (POC) SARS-CoV2 IgG Antibody Test. — 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SARS-CoV-2 IgG Antibody Testing Kit (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participant Health Care Workers With a Positive Rapid, At-home, Point-of-care (POC) SARS-CoV2 IgG Antibody Test. |
8 | — |
| SECONDARY Number of Healthcare Workers Willing to be Convalescent Plasma Donors if Appropriate |
426 | — |
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.
Eligibility Criteria
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
- Previously tested for COVID-19
Data sourced from ClinicalTrials.gov (NCT04334876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.