- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04540484
COVID-19 IgG Formation in Physicians at ALGH and Their Household Members
14 febbraio 2022 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Study is complete.
Data analysis is being put together.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
507
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
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Illinois
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Park Ridge, Illinois, Stati Uniti, 60068
- Advocate Lutheran General Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Advocate Lutheran General Hospital Physicians and their household members.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
---|---|
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
Altri nomi:
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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
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Identifying positive COVID-19 IgG formation
Lasso di tempo: up to 1 year
|
up to 1 year
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Physician Prevalence of COVID-19 serum IgG
Lasso di tempo: 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.
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up to 1 year
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Household Member Prevalence of COVID-19 serum IgG
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
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up to 1 year
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Asymptomatic Infection
Lasso di tempo: 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.
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1 year
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PPE Use and Positivity
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
26 agosto 2020
Completamento primario (Effettivo)
14 ottobre 2021
Completamento dello studio (Effettivo)
14 dicembre 2021
Date di iscrizione allo studio
Primo inviato
3 settembre 2020
Primo inviato che soddisfa i criteri di controllo qualità
3 settembre 2020
Primo Inserito (Effettivo)
7 settembre 2020
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
2 marzo 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 febbraio 2022
Ultimo verificato
1 febbraio 2022
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Infezioni da coronavirus
- Infezioni da Coronaviridae
- Infezioni da Nidovirus
- Infezioni da virus a RNA
- Malattie virali
- Infezioni delle vie respiratorie
- Malattie delle vie respiratorie
- Polmonite, virale
- Polmonite
- Malattie polmonari
- Attributi della malattia
- Grave sindrome respiratoria acuta
- COVID-19
- Infezioni
- Malattie trasmissibili
Altri numeri di identificazione dello studio
- 1606472-1
- M5500436 (Altro identificatore: ALGH)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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