Trial Outcomes & Findings for Rapid SARS-CoV-2 IgG Antibody Testing in High Risk Healthcare Workers (NCT NCT04334876)

NCT ID: NCT04334876

Last Updated: 2023-04-26

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 571 participants
• Primary outcome timeframe: 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
• Results posted on: 2023-04-26

Participant Flow

Inclusion criteria included High risk healthcare workers, prioritizing those working in the emergency room or intensive care units. A second tier of prioritization, was approached after the initial testing phase, which included expansion to other workers within the healthcare system. We excluded those that had previously tested positive for COVID-19

Participant milestones

Measure	High Risk Healthcare Workers At home, finger prick, antibody test. SARS-CoV-2 IgG Antibody Testing Kit: A, finger prick, at home test for SARS-CoV-2 IgG Antibodies.
Overall Study STARTED	571
Overall Study COMPLETED	500
Overall Study NOT COMPLETED	71

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	High Risk Healthcare Workers n=500 Participants At home, finger prick, antibody test. SARS-CoV-2 IgG Antibody Testing Kit: A, finger prick, at home test for SARS-CoV-2 IgG Antibodies.
Age, Continuous	37.5 years STANDARD_DEVIATION 10.4 • n=500 Participants
Sex: Female, Male Female	388 Participants n=500 Participants
Sex: Female, Male Male	112 Participants n=500 Participants
Region of Enrollment United States	500 Participants n=500 Participants
Participant profession Physicians	145 Participants n=500 Participants
Participant profession Nurses	226 Participants n=500 Participants
Participant profession Respiratory therapist	33 Participants n=500 Participants
Participant profession other healthcare workers	95 Participants n=500 Participants
Participant profession Unknown	1 Participants n=500 Participants

PRIMARY outcome

Timeframe: 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

Population: There was a total of 571 subjects consented. Of these, 71 were lost to follow-up, giving a total of 500 subjects who completed the survey and submitted results for the POC test. Of these 500, 58 subjects did a second follow up point of care test, and 15 patients completed a 3rd 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.

Outcome measures

Measure	High Risk Healthcare Workers n=500 Participants At home, finger prick, antibody test. SARS-CoV-2 IgG Antibody Testing Kit: A, finger prick, at home test for SARS-CoV-2 IgG Antibodies.
Number of Participant Health Care Workers With a Positive Rapid, At-home, Point-of-care (POC) SARS-CoV2 IgG Antibody Test.	8 Participants

SECONDARY outcome

Timeframe: 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.

Population: We surveyed the number of healthcare workers who would be wiling to donate plasma if found to have positive antibodies to SARS Co-V2 IgG

To identify possible candidates for convalescent plasma donation for therapy/prophylaxis

Outcome measures

Measure	High Risk Healthcare Workers n=500 Participants At home, finger prick, antibody test. SARS-CoV-2 IgG Antibody Testing Kit: A, finger prick, at home test for SARS-CoV-2 IgG Antibodies.
Number of Healthcare Workers Willing to be Convalescent Plasma Donors if Appropriate	426 Participants

Adverse Events

High Risk Healthcare Workers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Courtney Rowan

Indiana University

Phone: 317-944-7065

Email: coujohns@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place