- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04540484
COVID-19 IgG Formation in Physicians at ALGH and Their Household Members
2022년 2월 14일 업데이트: 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.
연구 개요
상세 설명
Study is complete.
Data analysis is being put together.
연구 유형
관찰
등록 (실제)
507
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Illinois
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Park Ridge, Illinois, 미국, 60068
- Advocate Lutheran General Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Advocate Lutheran General Hospital Physicians and their household members.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
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.
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Blood test screening for covid
다른 이름들:
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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.
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Blood test screening for covid
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Identifying positive COVID-19 IgG formation
기간: up to 1 year
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up to 1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Physician Prevalence of COVID-19 serum IgG
기간: up to 1 year
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The prevalence of COVID-19 serum IgG in physician participants at study entry, 3 months, 6 months, and 12 months after enrollment.
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up to 1 year
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Household Member Prevalence of COVID-19 serum IgG
기간: up to 1 year
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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.
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up to 1 year
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Physician Risk of Exposure
기간: up to 1 year
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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.
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up to 1 year
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Physician and Household Member Transmission
기간: up to 1 year
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The differences in prevalence of COVID-19 IgG in household members of physician participants that are positive for COVID-19 IgG.
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up to 1 year
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Asymptomatic Infection
기간: 1 year
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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.
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1 year
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PPE Use and Positivity
기간: up to 1 year
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The correlation between the prevalence of seropositivity and adherence to best practices regarding the use of personal protective equipment.
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up to 1 year
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Antibody Persistence
기간: up to 1 year
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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.
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up to 1 year
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2020년 8월 26일
기본 완료 (실제)
2021년 10월 14일
연구 완료 (실제)
2021년 12월 14일
연구 등록 날짜
최초 제출
2020년 9월 3일
QC 기준을 충족하는 최초 제출
2020년 9월 3일
처음 게시됨 (실제)
2020년 9월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 3월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 2월 14일
마지막으로 확인됨
2022년 2월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 1606472-1
- M5500436 (기타 식별자: ALGH)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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