NCT05357885

Brief Summary

This study is designed to compare the levels of SARS-CoV-2 antibody prior to cardiopulmonary bypass and after cardiopulmonary bypass (CPB).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

November 17, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 17, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
Last Updated

May 3, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

November 17, 2021

Last Update Submit

April 28, 2022

Conditions

Laboratory Assessment SARS-CoV-2 Antibody Levels Before and After Surgery for Patients Requiring Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

  • assess antibody levels before and after CPB.

    assess antibody levels before and after CPB.

    preop and up to 5 days post op

Interventions

SARS-CoV-2 Antibody testDIAGNOSTIC_TEST

SARS-CoV-2 antibody test at Jefferson is Roche Elecsys Anti-SARS-CoV-2 immunoassays performed under FDA's Emergency Use Authorization.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients presenting for elective cardiac surgery with the use of cardiopulmonary bypass that have received 2 or 3 doses of FDA approved or Emergency Use Authorization Covid vaccine

You may qualify if:

  • All patients presenting for elective cardiac surgery with the use of cardiopulmonary bypass that have received 2 or 3 doses of FDA approved or Emergency Use Authorization Covid vaccine.

You may not qualify if:

  • Age \< 18.
  • Patients with indeterminant history of vaccination schedule.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 17, 2021

First Posted

May 3, 2022

Study Start

November 17, 2021

Primary Completion

March 17, 2022

Study Completion

March 17, 2022

Last Updated

May 3, 2022

Record last verified: 2022-04

Locations

US(1)