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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV2 serum antibody testing | Diagnostic Test | Participants will have SARS-CoV2 serum antibody testing performed twice within 4 months of each other. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Serology Test #1 (Study Enrollment) and Test #2 (3 months apart) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020 |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Who Were Eligible for in Plasma Donation | Individuals who tested positive for COVID-19 who may be eligible for convalescent plasma donation | Serology Test #1 (Study Enrollment) and Test #2 (3 months apart) |
Inclusion Criteria:
Exclusion Criteria:
• Refusal to participate in either of the interventions at either of the timepoints of interest
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgeons and Anesthesiologists | Surgeons and anesthesiologists at a specialty orthopaedic hospital |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All attending surgeons, anesthesiologists, and trainees in both departments (orthopedic surgery fellows, anesthesiology fellows and orthopedic surgery residents) as identified via an institutional listserv.
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| ID | Title | Description |
|---|---|---|
| BG000 | Surgeons and Anesthesiologists | Surgeons and anesthesiologists at a specialty orthopaedic hospital |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Participating surgeons and anesthesiologists at a specialty orthopaedic hospital | Posted | Count of Participants | Participants | Serology Test #1 (Study Enrollment) and Test #2 (3 months apart) |
|
|
Adverse event data was not collected
Adverse event data was not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Surgeons and Anesthesiologists | Surgeons and anesthesiologists at a specialty orthopaedic hospital |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ellen M. Soffin | Hospital for Special Surgery | (212) 606-1206 | SoffinE@HSS.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 15, 2020 | Feb 22, 2022 | Prot_SAP_000.pdf |
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| 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 | Serology Test #1 (Study Enrollment) and Serology Test #2 (3 months apart) |
| 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 | Serology Test #1 (Study Enrollment) and Serology Test #2 (3 months apart) |
| 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. | Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020 |
| 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. | Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020 |
| 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. | Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020 |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Seroprevalence of SARS-CoV-2 IgG antibodies by serology testing | The seroprevalence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) immunoglobulin G (IgG) antibodies among surgeons and anesthesiologists and associated antibody status with coronavirus disease 2019 (COVID-19) clinical illness was measured. | Count of Participants | 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. | All surgeon and anesthesiologist participants with complete survey and serology testing data | Posted | Count of Participants | Participants | Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020 |
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|
|
| 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 | Number of asymptomatic participants with positive antibody serology (n=89/143) | Posted | Count of Participants | Participants | Serology Test #1 (Study Enrollment) and Serology Test #2 (3 months apart) |
|
|
|
| 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 | Symptomatic participants who were antibody-positive | Posted | Count of Participants | Participants | Serology Test #1 (Study Enrollment) and Serology Test #2 (3 months apart) |
|
|
|
| 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. | All surgeon and anesthesiologist participants with complete survey and serology testing data | Posted | Count of Participants | Participants | Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020 |
|
|
|
| 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. | All surgeon and anesthesiologist participants with complete survey and serology testing data | Posted | Count of Participants | Participants | Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020 |
|
|
|
| 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. | All surgeon and anesthesiologist participants with complete survey and serology testing data | Posted | Count of Participants | Participants | Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020 |
|
|
|
| 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 | Surgeons and anesthesiologists who completed both the survey and serology testing | Posted | Count of Participants | Participants | Serology Test #1 (Study Enrollment) and Test #2 (3 months apart) |
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| 0 |
| 0 |
| 0 |
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| 0 |
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| SARS-CoV-2 IgG Negative Males |
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| SARS-CoV-2 IgG Negative Blacks or African Americans |
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| SARS-CoV-2 IgG Positive Asians |
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| SARS-CoV-2 IgG Negative Asians |
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| SARS-CoV-2 IgG Positive Others/Unknown |
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| SARS-CoV-2 IgG Negative Others/Unknown |
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| SARS-CoV-2 IgG Negative Diabetes Mellitus |
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| SARS-CoV-2 IgG Positive Pulmonary Disease |
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| SARS-CoV-2 IgG Negative Pulmonary Disease |
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| SARS-CoV-2 IgG Positive CAD/Cardiac Condition |
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| SARS-CoV-2 IgG Negative CAD/Cardiac Condition |
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| SARS-CoV-2 IgG Positive Immunocompromised |
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| SARS-CoV-2 IgG Negative Immunocompromised |
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| SARS-CoV-2 IgG No Listed Comorbidities |
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