- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04389294
HSS Covid-19 Antibody Serology Among Surgeons & Anesthesiologists
March 21, 2023 updated by: Hospital for Special Surgery, New York
Hospital for Special Surgery COVID-19 Antibody Serology Among Anesthesiologists and Surgeons 2020
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
143
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Hospital for Special Surgery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With SARS-CoV-2 IgG Antibodies
Time Frame: 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
|
Serology Test #1 (Study Enrollment) and Test #2 (3 months apart)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in Sex Between IgG Antibody-positive vs. Negative Participants
Time Frame: 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.
|
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
Time Frame: 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
|
Serology Test #1 (Study Enrollment) and Serology Test #2 (3 months apart)
|
Percentage of Antibody-positive Participants Who Subsequently Develop COVID-19
Time Frame: 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
|
Serology Test #1 (Study Enrollment) and Serology Test #2 (3 months apart)
|
Differences in Race Between IgG Antibody-positive vs. Negative Participants
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants Who Were Eligible for in Plasma Donation
Time Frame: 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
|
Serology Test #1 (Study Enrollment) and Test #2 (3 months apart)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 5, 2020
Primary Completion (Actual)
June 16, 2020
Study Completion (Actual)
September 4, 2020
Study Registration Dates
First Submitted
May 8, 2020
First Submitted That Met QC Criteria
May 13, 2020
First Posted (Actual)
May 15, 2020
Study Record Updates
Last Update Posted (Estimated)
January 3, 2024
Last Update Submitted That Met QC Criteria
March 21, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-0850
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID
-
European Institute of OncologyFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta; Azienda Ospedaliera... and other collaboratorsCompleted
-
Owlstone LtdCambridge University Hospitals NHS Foundation TrustCompleted
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Sultan Qaboos UniversityCompletedCOVID-19 | Non-CovidOman
-
Assiut UniversityRecruiting
-
Jilin UniversityUnknown
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Miami VA Healthcare SystemNot yet recruiting
Clinical Trials on SARS-CoV2 serum antibody testing
-
Direction Centrale du Service de Santé des ArméesCompleted
-
Rutgers, The State University of New JerseyNational Institute of Dental and Craniofacial Research (NIDCR)Completed
-
Rutgers, The State University of New JerseyNational Institute of Dental and Craniofacial Research (NIDCR)Completed
-
Rutgers, The State University of New JerseyNational Institute of Dental and Craniofacial Research (NIDCR)CompletedSARS-CoV2 InfectionUnited States
-
Central Hospital, Nancy, FranceRecruitingSARS-CoV2 Infection | Proximal Tubule DysfunctionFrance
-
Centre Hospitalier Intercommunal CreteilAssociation Clinique Thérapeutique Infantile du val de Marne; GPIP; Francophone...Withdrawn
-
University Hospital, LilleFondation Santé RoquetteCompleted
-
University Hospital, LilleFondation Santé RoquetteUnknown