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COVID-19 IgG Formation in Physicians at ALGH and Their Household Members

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ClinicalTrials.gov Identifier: NCT04540484
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : September 9, 2020
Sponsor:
Collaborators:
Terika Richardson- President's Fund
Medical Staff Fund- Dr. John Ruge
Advocate Foundation- Ally Regnier and Chrisy Santos
Information provided by (Responsible Party):
Sigrun Hallmeyer, MD, Advocate Health Care

Tracking Information
First Submitted Date September 3, 2020
First Posted Date September 7, 2020
Last Update Posted Date September 9, 2020
Actual Study Start Date August 26, 2020
Estimated Primary Completion Date September 24, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 7, 2020)
Identifying positive COVID-19 IgG formation [ Time Frame: up to 1 year ]
Original Primary Outcome Measures
 (submitted: September 3, 2020)
Identifying positive COVID-19 IgG formation [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures
 (submitted: September 7, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: September 3, 2020)
  • Physician Result [ Time Frame: 1 year ]
    The prevalence of COVID-19 serum IgG in physician participants at study entry, 3 months, 6 months, and 12 months after enrollment.
  • Household Member of Physician Result [ Time Frame: 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.
  • Physician Risk of Exposure [ Time Frame: 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.
  • Physician and Household Member Transmission [ Time Frame: 1 year ]
    The differences in prevalence of COVID-19 IgG in household members of physician participants that are positive for COVID-19 IgG.
  • Asymptomatic Infection [ Time Frame: 1 year ]
    The relationship 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.
  • PPE Use and Positivity [ Time Frame: 1 year ]
    The relationship between the prevalence of seropositivity and adherence to best practices regarding the use of personal protective equipment.
  • Antibody Persistence [ Time Frame: 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title COVID-19 IgG Formation in Physicians at ALGH and Their Household Members
Official Title The Prevalence of SARS-CoV-2 IgG Antibody Formation in Physicians at Advocate Lutheran General Hospital and Their Household Members
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood Serum
Sampling Method Non-Probability Sample
Study Population Advocate Lutheran General Hospital Physicians and their household members.
Condition
  • Covid19
  • SARS-CoV Infection
  • Communicable Disease
Intervention Not Provided
Study Groups/Cohorts
  • 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.
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 3, 2020)
900
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 24, 2021
Estimated Primary Completion Date September 24, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Sigrun Hallmeyer, MD 8479717662 sigrun.hallmeyer@aah.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04540484
Other Study ID Numbers 1606472-1
M5500436 ( Other Identifier: ALGH )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Sigrun Hallmeyer, MD, Advocate Health Care
Study Sponsor Advocate Health Care
Collaborators
  • Terika Richardson- President's Fund
  • Medical Staff Fund- Dr. John Ruge
  • Advocate Foundation- Ally Regnier and Chrisy Santos
Investigators Not Provided
PRS Account Advocate Health Care
Verification Date September 2020