COVID Clinical Trial
Official title:
Hospital for Special Surgery COVID-19 Antibody Serology Among Anesthesiologists and Surgeons 2020
| NCT number | NCT04389294 |
| Other study ID # | 2020-0850 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 5, 2020 |
| Est. completion date | September 4, 2020 |
| Verified date | March 2023 |
| Source | Hospital for Special Surgery, New York |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 143 |
| Est. completion date | September 4, 2020 |
| Est. primary completion date | June 16, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 21 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Hospital for Special Surgery | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital for Special Surgery, New York |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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) | |
| 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 | Serology Test #1 (Study Enrollment) and Test #2 (3 months apart) | |
| 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. | Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020 | |
| 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 | 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 | 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. | 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. | 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. | Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020 |
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