COVIDNCT04389294

HSS Covid-19 Antibody Serology Among Surgeons & Anesthesiologists

A study testing SARS-CoV2 serum antibody testing in people with COVID, run by Hospital for Special Surgery, New York at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: COVID
What is being tested?: SARS-CoV2 serum antibody testing
How many people: 143 participants
Where: 1 siteUnited States
Study dates: 5 May 2020to 4 Sep 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital for Special Surgery
New York, New York, 10021

Other trials in United States

About this study

Official title: Hospital for Special Surgery COVID-19 Antibody Serology Among Anesthesiologists and Surgeons 2020

Conditions: COVID
Being tested: SARS-CoV2 serum antibody testing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 May 20204 Sep 2020

First posted15 May 2020
Study start5 May 2020
Primary completion16 Jun 2020
Study completion4 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVIDStudies of the same condition, open and under way.
More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 143 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04389294
Sponsor's protocol ID: 2020-0850
Status last verified: Mar 2023
First submitted: 8 May 2020
Last updated: 3 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hospital for Special Surgery COVID-19 Antibody Serology Among Anesthesiologists and Surgeons 2020
ClinicalTrials.gov ID: NCT04389294
Acronym / sponsor ID: 2020-0850
Conditions: COVID
Study type: Interventional
Recruitment status: Completed
Enrolment: 143 participants (actual)
Lead sponsor: Hospital for Special Surgery, New YorkUniversity, hospital or other
Study start: 5 May 2020 (actual)
Primary completion: 16 Jun 2020 (actual)
Study completion: 4 Sep 2020 (actual)
First posted: 15 May 2020 (actual)
Results: Posted 3 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SARS-CoV2 serum antibody testingParticipants will have SARS-CoV2 serum antibody testing performed twice within 4 months of each other.	Diagnostic test	–

Primary outcome

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

6 secondary outcomes

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
Number of Asymptomatic Participants With Positive Antibody Serology
Time frame: 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)
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
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
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

Results and safety

Results posted to the registry on 3 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Surgeons and Anesthesiologists	143	143

Primary outcome: Number of Participants With SARS-CoV-2 IgG Antibodies

Time frame: Serology Test #1 (Study Enrollment) and Test #2 (3 months apart). Count of participants. Unit: Participants

Measure	Surgeons and Anesthesiologists n = 143
Value	14

Population analysed: Participating surgeons and anesthesiologists at a specialty orthopaedic hospital

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was not collected. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Surgeons and Anesthesiologists	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for COVID

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SARS-CoV2 serum antibody testing in people with COVID, run by Hospital for Special Surgery, New York at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With SARS-CoV-2 IgG Antibodies (time frame: Serology Test #1 (Study Enrollment) and Test #2 (3 months apart)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04389294.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.