- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04540484
COVID-19 IgG Formation in Physicians at ALGH and Their Household Members
February 14, 2022 updated by: Sigrun Hallmeyer, MD, Advocate Health Care
The Prevalence of SARS-CoV-2 IgG Antibody Formation in Physicians at Advocate Lutheran General Hospital and Their Household Members
This study is a community hospital-based study that will enhance information being obtained in similar studies taking place in France, Denmark, and China.
These studies are designed to assess risk of healthcare workers during outbreaks of Coronavirus 2019 (COVID-19) also known as sudden acute respiratory syndrome-coronavirus-2 (SARS-CoV-2).
This will be a prospective, single-center observational study involving human subjects.
IgG (Immunoglobulin G) antibody will be tested in the serum of physicians working at Advocate Lutheran General Hospital (ALGH).
IgG antibodies are the antibodies that form in response to viral or bacterial infections and typically reflect protection against said infection.
To date, there have been no studies confirming that IgG antibody formation confers immunity, but studies are ongoing.
Furthermore, data is lacking showing conclusive persistence of (possibly protective) antibodies over time.
Attending physicians on the medical staff, fellow physicians, and house staff residents who worked at ALGH from March 1st, 2020 and on, will be eligible for the study.
Testing will involve a venipuncture to obtain approximately 3mL of blood to be sent to ACL Laboratories for SARS-CoV-2 IgG testing.
For physician subjects, this will be performed on four separate occasions, once at the onset of the study, a second test 3 months after the first test, a third test 6 months from the time of the first test, and a fourth and final test 12 months after the initial test.
Two household members (defined below), one-time testing will occur within 2 weeks of the physician subject testing positive.
All testing will be performed in a two-week window.
All physician subjects will be tested at a centralized site that is only serving these subjects, by appointment.
We will be offloading testing for household members to one localized commercial ACL site on the ALGH campus at the Center for Advanced Care.
The household member testing will be extended to an additional two-week period after the two week window in which physicians are tested for a total of four weeks maximum.
One-time testing for IgG antibodies to COVID-19 will be offered to a maximum of two household members, as defined as, any person over the age of 18 years old who has lived at home with the physician, who has tested positive for IgG antibodies, for at least 2 weeks in total duration since March 1st, 2020.
The physician will be permitted to choose who gets tested, and the chosen adult subject will provide their independent consent to be tested.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Study is complete.
Data analysis is being put together.
Study Type
Observational
Enrollment (Actual)
507
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
-
-
Illinois
-
Park Ridge, Illinois, United States, 60068
- Advocate Lutheran General Hospital
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Advocate Lutheran General Hospital Physicians and their household members.
Description
Inclusion Criteria:
- Attending physician staff members, fellow physicians, and resident house staff members who were on staff at ALGH from March 1st, 2020 and on, with potential exposure to COVID-19 patients.
- A maximum of two adult household members as defined as, any person over the age of 18 years old who has lived at home with the physician for at least 2 weeks in total duration since March 1st, 2020. Any adult household member of attending physicians on the medical staff, fellow physicians, and resident physicians may qualify as long as the tested physician resulted positive for IgG Antibodies to COVID-19. The adult household member will be selected by the household physician based on their assessment of risk of also testing positive.
- Must be willing to undergo venipuncture, sign consent and complete the questionnaire. Participants need to speak, read, and understand English at the literacy level of a 8th grader.
- Those with a prior documented COVID-19 infection are eligible for study inclusion. We will rely on self-reporting by physicians due to the fact that the data from the other study conducted in the Advocate Aurora System has been de-identified and we cannot access the results on individual participants in our study.
Exclusion Criteria:
- Healthcare providers and/or their household members who would not want venipuncture performed on them
- Healthcare workers who are not on the medical staff or members of the resident house staff
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ALGH Physicians
Attending physicians on the medical staff, fellow physicians, and resident physicians that work at Advocate Lutheran General Hospital (ALGH) from March 1st, 2020 and forward.
|
Blood test screening for covid
Other Names:
|
Household Members
Household members above age 18 who lived in household of ALGH physician who tested positive for COVID-19 IgG antibodies, and who lived with that physician for at least 2 consecutive weeks.
|
Blood test screening for covid
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Identifying positive COVID-19 IgG formation
Time Frame: up to 1 year
|
up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physician Prevalence of COVID-19 serum IgG
Time Frame: up to 1 year
|
The prevalence of COVID-19 serum IgG in physician participants at study entry, 3 months, 6 months, and 12 months after enrollment.
|
up to 1 year
|
Household Member Prevalence of COVID-19 serum IgG
Time Frame: up to 1 year
|
The prevalence of COVID-19 serum IgG in household members (as defined above) of physician participants that are positive at the time the associated physician tested positive.
|
up to 1 year
|
Physician Risk of Exposure
Time Frame: up to 1 year
|
The differences in prevalence of COVID-19 IgG in physician participants that are deemed to be at minimum, moderate or high risk of COVID-19 exposure.
|
up to 1 year
|
Physician and Household Member Transmission
Time Frame: up to 1 year
|
The differences in prevalence of COVID-19 IgG in household members of physician participants that are positive for COVID-19 IgG.
|
up to 1 year
|
Asymptomatic Infection
Time Frame: 1 year
|
The correlation between IgG prevalence and previous COVID-19 symptoms - a means of quantifying the presence of asymptomatic carriers amongst the medical staff, an important and heretofore poorly described vector of transmission.
|
1 year
|
PPE Use and Positivity
Time Frame: up to 1 year
|
The correlation between the prevalence of seropositivity and adherence to best practices regarding the use of personal protective equipment.
|
up to 1 year
|
Antibody Persistence
Time Frame: up to 1 year
|
The development of COVID19 infections in physicians at our hospital over the test period of 12 months, and its correlation to Covid19_IgG positivity.
This will allow us to understand the persistence of the antibody and its potential neutralizing power, over time.
|
up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
August 26, 2020
Primary Completion (Actual)
October 14, 2021
Study Completion (Actual)
December 14, 2021
Study Registration Dates
First Submitted
September 3, 2020
First Submitted That Met QC Criteria
September 3, 2020
First Posted (Actual)
September 7, 2020
Study Record Updates
Last Update Posted (Actual)
March 2, 2022
Last Update Submitted That Met QC Criteria
February 14, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- Severe Acute Respiratory Syndrome
- COVID-19
- Infections
- Communicable Diseases
Other Study ID Numbers
- 1606472-1
- M5500436 (Other Identifier: ALGH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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