NCT04389294

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2020

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

January 3, 2024

Completed
Last Updated

January 3, 2024

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

May 8, 2020

Results QC Date

March 29, 2022

Last Update Submit

March 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • Number of Asymptomatic Participants With Positive Antibody Serology

    Serology Test #1 (Study Enrollment) and Serology Test #2 (3 months apart)

  • Percentage of Antibody-positive Participants Who Subsequently Develop COVID-19

    Serology Test #1 (Study Enrollment) and Serology Test #2 (3 months apart)

  • 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

  • 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

  • +1 more secondary outcomes

Other Outcomes (1)

  • Participants Who Were Eligible for in Plasma Donation

    Serology Test #1 (Study Enrollment) and Test #2 (3 months apart)

Interventions

Participants will have SARS-CoV2 serum antibody testing performed twice within 4 months of each other.

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Accredited to practice at HSS
  • All anesthesiology and surgery faculty
  • All anesthesia and orthopedic surgery fellows
  • All orthopedic surgery residents

You may not qualify if:

  • Refusal to participate in either of the interventions at either of the timepoints of interest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Results Point of Contact

Title
Dr. Ellen M. Soffin
Organization
Hospital for Special Surgery

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2020

First Posted

May 15, 2020

Study Start

May 5, 2020

Primary Completion

June 16, 2020

Study Completion

September 4, 2020

Last Updated

January 3, 2024

Results First Posted

January 3, 2024

Record last verified: 2023-03

Locations