Trial Outcomes & Findings for HSS Covid-19 Antibody Serology Among Surgeons & Anesthesiologists (NCT NCT04389294)

NCT ID: NCT04389294

Last Updated: 2024-01-03

Results Overview

Prevalence of SARS-CoV-2 IgG antibodies by serology testing in participants at the time of study enrollment or 3 months later

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 143 participants
• Primary outcome timeframe: Serology Test #1 (Study Enrollment) and Test #2 (3 months apart)
• Results posted on: 2024-01-03

Participant Flow

Participant milestones

Measure	Surgeons and Anesthesiologists Surgeons and anesthesiologists at a specialty orthopaedic hospital
Overall Study STARTED	143
Overall Study COMPLETED	143
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HSS Covid-19 Antibody Serology Among Surgeons & Anesthesiologists

Baseline characteristics by cohort

Measure	Surgeons and Anesthesiologists n=143 Participants Surgeons and anesthesiologists at a specialty orthopaedic hospital
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	125 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants
Age, Continuous	41.4 years n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	117 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	109 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	20 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	110 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	143 participants n=5 Participants
Seroprevalence of SARS-CoV-2 IgG antibodies by serology testing	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Serology Test #1 (Study Enrollment) and Test #2 (3 months apart)

Population: Participating surgeons and anesthesiologists at a specialty orthopaedic hospital

Prevalence of SARS-CoV-2 IgG antibodies by serology testing in participants at the time of study enrollment or 3 months later

Outcome measures

Measure	Surgeons and Anesthesiologists n=143 Participants Surgeons and anesthesiologists at a specialty orthopaedic hospital
Number of Participants With SARS-CoV-2 IgG Antibodies	14 Participants

SECONDARY outcome

Timeframe: Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020

Population: All surgeon and anesthesiologist participants with complete survey and serology testing data

Secondary outcomes included differences in the survey responses between IgG antibody-positive and -negative participants. These included demographics such as sex.

Outcome measures

Measure	Surgeons and Anesthesiologists n=143 Participants Surgeons and anesthesiologists at a specialty orthopaedic hospital
Differences in Sex Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Positive Females	2 Participants
Differences in Sex Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Negative Females	24 Participants
Differences in Sex Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Positive Males	12 Participants
Differences in Sex Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Negative Males	105 Participants

SECONDARY outcome

Timeframe: Serology Test #1 (Study Enrollment) and Serology Test #2 (3 months apart)

Population: Number of asymptomatic participants with positive antibody serology (n=89/143)

Number of asymptomatic participants with positive antibody serology at either the study enrollment timepoint or 3 month timepoint

Outcome measures

Measure	Surgeons and Anesthesiologists n=89 Participants Surgeons and anesthesiologists at a specialty orthopaedic hospital
Number of Asymptomatic Participants With Positive Antibody Serology	2 Participants

SECONDARY outcome

Timeframe: Serology Test #1 (Study Enrollment) and Serology Test #2 (3 months apart)

Population: Symptomatic participants who were antibody-positive

Percentage of antibody-positive participants who subsequently develop COVID-19 at either the study enrollment timepoint or the 3 months time point

Outcome measures

Measure	Surgeons and Anesthesiologists n=54 Participants Surgeons and anesthesiologists at a specialty orthopaedic hospital
Percentage of Antibody-positive Participants Who Subsequently Develop COVID-19	12 Participants

SECONDARY outcome

Timeframe: Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020

Population: All surgeon and anesthesiologist participants with complete survey and serology testing data

Secondary outcomes included differences in the survey responses between IgG antibody-positive and -negative participants. These included demographics such as race.

Outcome measures

Measure	Surgeons and Anesthesiologists n=143 Participants Surgeons and anesthesiologists at a specialty orthopaedic hospital
Differences in Race Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Positive Whites	10 Participants
Differences in Race Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Negative Whites	99 Participants
Differences in Race Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Positive Blacks or African Americans	2 Participants
Differences in Race Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Negative Blacks or African Americans	6 Participants
Differences in Race Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Positive Asians	2 Participants
Differences in Race Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Negative Asians	18 Participants
Differences in Race Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Positive Others/Unknown	0 Participants
Differences in Race Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Negative Others/Unknown	6 Participants

SECONDARY outcome

Timeframe: Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020

Population: All surgeon and anesthesiologist participants with complete survey and serology testing data

Secondary outcomes included differences in the survey responses between IgG antibody-positive and -negative participants. These included demographics such as number of adult household members.

Outcome measures

Measure	Surgeons and Anesthesiologists n=143 Participants Surgeons and anesthesiologists at a specialty orthopaedic hospital
Differences in Average Number of Adults in Household Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Positive	14 Participants
Differences in Average Number of Adults in Household Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Negative	129 Participants

SECONDARY outcome

Timeframe: Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020

Population: All surgeon and anesthesiologist participants with complete survey and serology testing data

Secondary outcomes included differences in the survey responses between IgG antibody-positive and -negative participants. These included comorbidities.

Outcome measures

Measure	Surgeons and Anesthesiologists n=143 Participants Surgeons and anesthesiologists at a specialty orthopaedic hospital
Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Positive Hypertension	0 Participants
Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Negative Hypertension	13 Participants
Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Positive Diabetes Mellitus	0 Participants
Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Negative Diabetes Mellitus	1 Participants
Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Positive Pulmonary Disease	1 Participants
Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Negative Pulmonary Disease	9 Participants
Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Positive CAD/Cardiac Condition	0 Participants
Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Negative CAD/Cardiac Condition	3 Participants
Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Positive Immunocompromised	0 Participants
Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG Negative Immunocompromised	3 Participants
Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants SARS-CoV-2 IgG No Listed Comorbidities	113 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Serology Test #1 (Study Enrollment) and Test #2 (3 months apart)

Population: Surgeons and anesthesiologists who completed both the survey and serology testing

Individuals who tested positive for COVID-19 who may be eligible for convalescent plasma donation

Outcome measures

Measure	Surgeons and Anesthesiologists n=143 Participants Surgeons and anesthesiologists at a specialty orthopaedic hospital
Participants Who Were Eligible for in Plasma Donation	14 Participants

Adverse Events

Surgeons and Anesthesiologists

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

Dr. Ellen M. Soffin

Hospital for Special Surgery

Phone: (212) 606-1206

Email: SoffinE@HSS.edu

Results disclosure agreements

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