Trial Outcomes & Findings for Seroprevalence of SARS CoV 2 Antibodies in Previously Undiagnosed Healthcare Workers (NCT NCT04383587)

Results Overview

Presence of IgG antibodies detected

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

300 participants

Primary outcome timeframe

1 month

Results posted on

2022-04-13

Participant Flow

394 invited to participate. 300 elected to participate. 292 completed study.

Participant milestones

Participant milestones
Measure	Serologic Arm Enrolled participants will have COVID19 IgG antibody testing performed. Serologic testing: COVID19 IgG antibody testing performed
Overall Study STARTED	300
Overall Study COMPLETED	292
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Serology Group n=292 Participants Group of participants completing COVID Serologic antibody testing
Age, Categorical <=18 years	0 Participants n=292 Participants
Age, Categorical Between 18 and 65 years	284 Participants n=292 Participants
Age, Categorical >=65 years	8 Participants n=292 Participants
Age, Continuous	43 years n=292 Participants
Sex: Female, Male Female	174 Participants n=292 Participants
Sex: Female, Male Male	118 Participants n=292 Participants
Region of Enrollment United States	292 participants n=292 Participants

PRIMARY outcome

Timeframe: 1 month

Presence of IgG antibodies detected

Outcome measures

Outcome measures
Measure	Serologic Arm n=292 Participants Enrolled participants will have COVID19 IgG antibody testing performed. Serologic testing: COVID19 IgG antibody testing performed
Number of Participants With COVID-19 Antibodies Positive Antibodies	8 Participants
Number of Participants With COVID-19 Antibodies Negative Antibodies	284 Participants

SECONDARY outcome

Timeframe: Single point in time prior to COVID-19 Antibody testing

Population: Of 292 participants completing the study, 27 responded in a survey (prior to antibody testing) that they had a high confidence (8 or greater on a Likert Scale from 0-10) that they had been previously infected with SARS CoV-2 and would test COVID-19 antibody positive. Antibody results from those 27 participants are listed below.

Survey of participants to gauge their confidence they will be antibody positive

Outcome measures

Outcome measures
Measure	Serologic Arm n=27 Participants Enrolled participants will have COVID19 IgG antibody testing performed. Serologic testing: COVID19 IgG antibody testing performed
Ability to Predict Immune Status/Antibody Positivity Antibody negative	26 Participants
Ability to Predict Immune Status/Antibody Positivity Antibody positive	1 Participants

Adverse Events

Serologic Arm

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

Mark A. Parkulo, MD

Mayo Clinic

Phone: 9049532000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place