COVID
Conditions
Brief summary
The goal of this study is to understand the infectious exposure of SARS-coronavirus 2 (SARS-CoV2) among surgeons and anesthesiologists and to correlate this status with self-reported indices of COVID-19 illness.
Interventions
DIAGNOSTIC_TESTSARS-CoV2 serum antibody testing
Participants will have SARS-CoV2 serum antibody testing performed twice within 4 months of each other.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Accredited to practice at HSS * All anesthesiology and surgery faculty * All anesthesia and orthopedic surgery fellows * All orthopedic surgery residents
Exclusion criteria
• Refusal to participate in either of the interventions at either of the timepoints of interest
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With SARS-CoV-2 IgG Antibodies | Serology Test #1 (Study Enrollment) and Test #2 (3 months apart) | Prevalence of SARS-CoV-2 IgG antibodies by serology testing in participants at the time of study enrollment or 3 months later |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Sex Between IgG Antibody-positive vs. Negative Participants | Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020 | Secondary outcomes included differences in the survey responses between IgG antibody-positive and -negative participants. These included demographics such as sex. |
| Number of Asymptomatic Participants With Positive Antibody Serology | Serology Test #1 (Study Enrollment) and Serology Test #2 (3 months apart) | Number of asymptomatic participants with positive antibody serology at either the study enrollment timepoint or 3 month timepoint |
| Percentage of Antibody-positive Participants Who Subsequently Develop COVID-19 | Serology Test #1 (Study Enrollment) and Serology Test #2 (3 months apart) | Percentage of antibody-positive participants who subsequently develop COVID-19 at either the study enrollment timepoint or the 3 months time point |
| Differences in Average Number of Adults in Household Between IgG Antibody-positive vs. Negative Participants | Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020 | 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. |
| Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants | Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020 | Secondary outcomes included differences in the survey responses between IgG antibody-positive and -negative participants. These included comorbidities. |
| Differences in Race Between IgG Antibody-positive vs. Negative Participants | Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020 | Secondary outcomes included differences in the survey responses between IgG antibody-positive and -negative participants. These included demographics such as race. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Participants Who Were Eligible for in Plasma Donation | Serology Test #1 (Study Enrollment) and Test #2 (3 months apart) | Individuals who tested positive for COVID-19 who may be eligible for convalescent plasma donation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Surgeons and Anesthesiologists Surgeons and anesthesiologists at a specialty orthopaedic hospital | 143 |
| Total | 143 |
Baseline characteristics
| Characteristic | Surgeons and Anesthesiologists |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 125 Participants |
| Age, Continuous | 41.4 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 109 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 20 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 110 Participants |
| Region of Enrollment United States | 143 participants |
| Seroprevalence of SARS-CoV-2 IgG antibodies by serology testing | 14 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Participants With SARS-CoV-2 IgG Antibodies
Prevalence of SARS-CoV-2 IgG antibodies by serology testing in participants at the time of study enrollment or 3 months later
Time frame: Serology Test #1 (Study Enrollment) and Test #2 (3 months apart)
Population: Participating surgeons and anesthesiologists at a specialty orthopaedic hospital
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Surgeons and Anesthesiologists | Number of Participants With SARS-CoV-2 IgG Antibodies | 14 Participants |
Secondary
Differences in Average Number of Adults in Household Between IgG Antibody-positive vs. Negative Participants
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.
Time frame: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Surgeons and Anesthesiologists | Differences in Average Number of Adults in Household Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Positive | 14 Participants |
| Surgeons and Anesthesiologists | Differences in Average Number of Adults in Household Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Negative | 129 Participants |
Secondary
Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants
Secondary outcomes included differences in the survey responses between IgG antibody-positive and -negative participants. These included comorbidities.
Time frame: 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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Surgeons and Anesthesiologists | Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Positive Diabetes Mellitus | 0 Participants |
| Surgeons and Anesthesiologists | Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Positive Hypertension | 0 Participants |
| Surgeons and Anesthesiologists | Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Negative Hypertension | 13 Participants |
| Surgeons and Anesthesiologists | Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Negative Diabetes Mellitus | 1 Participants |
| Surgeons and Anesthesiologists | Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Positive Pulmonary Disease | 1 Participants |
| Surgeons and Anesthesiologists | Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Negative Pulmonary Disease | 9 Participants |
| Surgeons and Anesthesiologists | Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Positive CAD/Cardiac Condition | 0 Participants |
| Surgeons and Anesthesiologists | Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Negative CAD/Cardiac Condition | 3 Participants |
| Surgeons and Anesthesiologists | Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Positive Immunocompromised | 0 Participants |
| Surgeons and Anesthesiologists | Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Negative Immunocompromised | 3 Participants |
| Surgeons and Anesthesiologists | Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG No Listed Comorbidities | 113 Participants |
Secondary
Differences in Race Between IgG Antibody-positive vs. Negative Participants
Secondary outcomes included differences in the survey responses between IgG antibody-positive and -negative participants. These included demographics such as race.
Time frame: 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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Surgeons and Anesthesiologists | Differences in Race Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Positive Whites | 10 Participants |
| Surgeons and Anesthesiologists | Differences in Race Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Negative Whites | 99 Participants |
| Surgeons and Anesthesiologists | Differences in Race Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Positive Blacks or African Americans | 2 Participants |
| Surgeons and Anesthesiologists | Differences in Race Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Negative Blacks or African Americans | 6 Participants |
| Surgeons and Anesthesiologists | Differences in Race Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Positive Asians | 2 Participants |
| Surgeons and Anesthesiologists | Differences in Race Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Negative Asians | 18 Participants |
| Surgeons and Anesthesiologists | Differences in Race Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Positive Others/Unknown | 0 Participants |
| Surgeons and Anesthesiologists | Differences in Race Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Negative Others/Unknown | 6 Participants |
Secondary
Differences in Sex Between IgG Antibody-positive vs. Negative Participants
Secondary outcomes included differences in the survey responses between IgG antibody-positive and -negative participants. These included demographics such as sex.
Time frame: 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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Surgeons and Anesthesiologists | Differences in Sex Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Positive Females | 2 Participants |
| Surgeons and Anesthesiologists | Differences in Sex Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Negative Females | 24 Participants |
| Surgeons and Anesthesiologists | Differences in Sex Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Positive Males | 12 Participants |
| Surgeons and Anesthesiologists | Differences in Sex Between IgG Antibody-positive vs. Negative Participants | SARS-CoV-2 IgG Negative Males | 105 Participants |
Secondary
Number of Asymptomatic Participants With Positive Antibody Serology
Number of asymptomatic participants with positive antibody serology at either the study enrollment timepoint or 3 month timepoint
Time frame: Serology Test #1 (Study Enrollment) and Serology Test #2 (3 months apart)
Population: Number of asymptomatic participants with positive antibody serology (n=89/143)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Surgeons and Anesthesiologists | Number of Asymptomatic Participants With Positive Antibody Serology | 2 Participants |
Secondary
Percentage of Antibody-positive Participants Who Subsequently Develop COVID-19
Percentage of antibody-positive participants who subsequently develop COVID-19 at either the study enrollment timepoint or the 3 months time point
Time frame: Serology Test #1 (Study Enrollment) and Serology Test #2 (3 months apart)
Population: Symptomatic participants who were antibody-positive
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Surgeons and Anesthesiologists | Percentage of Antibody-positive Participants Who Subsequently Develop COVID-19 | 12 Participants |
Other Pre-specified
Participants Who Were Eligible for in Plasma Donation
Individuals who tested positive for COVID-19 who may be eligible for convalescent plasma donation
Time frame: Serology Test #1 (Study Enrollment) and Test #2 (3 months apart)
Population: Surgeons and anesthesiologists who completed both the survey and serology testing
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Surgeons and Anesthesiologists | Participants Who Were Eligible for in Plasma Donation | 14 Participants |