An interventional study of SARS-CoV2 serum antibody testing in COVID, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-03.
Sponsored by Hospital for Special Surgery, New York · Not applicable, Interventional, and Health services research
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.
Hospital for Special Surgery, New York is the lead sponsor of 217 studies on the registry; 39 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 20 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will have SARS-CoV2 serum antibody testing performed twice within 4 months of each other.
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)
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
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)
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)
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
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
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
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)
| Milestone | Surgeons and Anesthesiologists |
|---|---|
| Started | 143 |
| Completed | 143 |
| Not completed | 0 |
Prevalence of SARS-CoV-2 IgG antibodies by serology testing in participants at the time of study enrollment or 3 months later
| Participants | Surgeons and Anesthesiologists |
|---|---|
| Number of Participants With SARS-CoV-2 IgG Antibodies | 14 |
Secondary outcomes included differences in the survey responses between IgG antibody-positive and -negative participants. These included demographics such as sex.
| Participants | Surgeons and Anesthesiologists |
|---|---|
| SARS-CoV-2 IgG Positive Females | 2 |
| SARS-CoV-2 IgG Negative Females | 24 |
| SARS-CoV-2 IgG Positive Males | 12 |
| SARS-CoV-2 IgG Negative Males | 105 |
Number of asymptomatic participants with positive antibody serology at either the study enrollment timepoint or 3 month timepoint
| Participants | Surgeons and Anesthesiologists |
|---|---|
| Number of Asymptomatic Participants With Positive Antibody Serology | 2 |
Percentage of antibody-positive participants who subsequently develop COVID-19 at either the study enrollment timepoint or the 3 months time point
| Participants | Surgeons and Anesthesiologists |
|---|---|
| Percentage of Antibody-positive Participants Who Subsequently Develop COVID-19 | 12 |
Secondary outcomes included differences in the survey responses between IgG antibody-positive and -negative participants. These included demographics such as race.
| Participants | Surgeons and Anesthesiologists |
|---|---|
| SARS-CoV-2 IgG Positive Whites | 10 |
| SARS-CoV-2 IgG Negative Whites | 99 |
| SARS-CoV-2 IgG Positive Blacks or African Americans | 2 |
| SARS-CoV-2 IgG Negative Blacks or African Americans | 6 |
| SARS-CoV-2 IgG Positive Asians | 2 |
| SARS-CoV-2 IgG Negative Asians | 18 |
| SARS-CoV-2 IgG Positive Others/Unknown | 0 |
| SARS-CoV-2 IgG Negative Others/Unknown | 6 |
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.
| Participants | Surgeons and Anesthesiologists |
|---|---|
| SARS-CoV-2 IgG Positive | 14 |
| SARS-CoV-2 IgG Negative | 129 |
Secondary outcomes included differences in the survey responses between IgG antibody-positive and -negative participants. These included comorbidities.
| Participants | Surgeons and Anesthesiologists |
|---|---|
| SARS-CoV-2 IgG Positive Hypertension | 0 |
| SARS-CoV-2 IgG Negative Hypertension | 13 |
| SARS-CoV-2 IgG Positive Diabetes Mellitus | 0 |
| SARS-CoV-2 IgG Negative Diabetes Mellitus | 1 |
| SARS-CoV-2 IgG Positive Pulmonary Disease | 1 |
| SARS-CoV-2 IgG Negative Pulmonary Disease | 9 |
| SARS-CoV-2 IgG Positive CAD/Cardiac Condition | 0 |
| SARS-CoV-2 IgG Negative CAD/Cardiac Condition | 3 |
| SARS-CoV-2 IgG Positive Immunocompromised | 0 |
| SARS-CoV-2 IgG Negative Immunocompromised | 3 |
| SARS-CoV-2 IgG No Listed Comorbidities | 113 |
Individuals who tested positive for COVID-19 who may be eligible for convalescent plasma donation
| Participants | Surgeons and Anesthesiologists |
|---|---|
| Participants Who Were Eligible for in Plasma Donation | 14 |
Collected over Adverse event data was not collected. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Surgeons and Anesthesiologists | — | — | — |
All attending surgeons, anesthesiologists, and trainees in both departments (orthopedic surgery fellows, anesthesiology fellows and orthopedic surgery residents) as identified via an institutional listserv.
| Age, Categorical(Participants) | Surgeons and Anesthesiologists |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 125 |
| >=65 years | 18 |
| Age, Continuous(years) | Surgeons and Anesthesiologists |
|---|---|
| Median | 41.4 (33 to 50.5) |
| Sex: Female, Male(Participants) | Surgeons and Anesthesiologists |
|---|---|
| Female | 26 |
| Male | 117 |
| Ethnicity (NIH/OMB)(Participants) | Surgeons and Anesthesiologists |
|---|---|
| Hispanic or Latino | 28 |
| Not Hispanic or Latino | 109 |
| Unknown or Not Reported | 6 |
| Race (NIH/OMB)(Participants) | Surgeons and Anesthesiologists |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 20 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 8 |
| White | 110 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | Surgeons and Anesthesiologists |
|---|---|
| United States | 143 |
| Seroprevalence of SARS-CoV-2 IgG antibodies by serology testing(Participants) | Surgeons and Anesthesiologists |
|---|---|
| Count of participants | 14 |
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Hospital for Special Surgery, New York