- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04540484
COVID-19 IgG Formation in Physicians at ALGH and Their Household Members
14 de fevereiro de 2022 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Study is complete.
Data analysis is being put together.
Tipo de estudo
Observacional
Inscrição (Real)
507
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Illinois
-
Park Ridge, Illinois, Estados Unidos, 60068
- Advocate Lutheran General Hospital
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Advocate Lutheran General Hospital Physicians and their household members.
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
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
Outros nomes:
|
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
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Identifying positive COVID-19 IgG formation
Prazo: up to 1 year
|
up to 1 year
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Physician Prevalence of COVID-19 serum IgG
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
26 de agosto de 2020
Conclusão Primária (Real)
14 de outubro de 2021
Conclusão do estudo (Real)
14 de dezembro de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
3 de setembro de 2020
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de setembro de 2020
Primeira postagem (Real)
7 de setembro de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de março de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de fevereiro de 2022
Última verificação
1 de fevereiro de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Processos Patológicos
- Infecções por coronavírus
- Infecções por Coronaviridae
- Infecções por Nidovírus
- Infecções por vírus de RNA
- Doenças Virais
- Infecções do Trato Respiratório
- Doenças Respiratórias
- Pneumonia Viral
- Pneumonia
- Doenças pulmonares
- Atributos da doença
- Síndrome Respiratória Aguda Grave
- COVID-19
- Infecções
- Doenças Transmissíveis
Outros números de identificação do estudo
- 1606472-1
- M5500436 (Outro identificador: ALGH)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Covid19
-
Anavasi DiagnosticsAinda não está recrutando
-
Ain Shams UniversityRecrutamento
-
Israel Institute for Biological Research (IIBR)Concluído
-
Colgate PalmoliveConcluído
-
Christian von BuchwaldConcluído
-
Luye Pharma Group Ltd.Shandong Boan Biotechnology Co., LtdAtivo, não recrutando
-
University of ZurichLabor Speiz; Swiss Armed Forces; Universitätsspital ZürichInscrevendo-se por convite
-
Alexandria UniversityConcluído
Ensaios clínicos em Screening
-
Gobiquity Mobile HealthConcluído
-
BDH-Klinik Hessisch OldendorfRecrutamento
-
Madigan Army Medical CenterRecrutamentoInfecções sexualmente transmissíveisEstados Unidos
-
Shahid Beheshti University of Medical SciencesConcluídoCegueira | Deficiência visualIrã (Republic Islâmica do Irã
-
University of HawaiiAtivo, não recrutando