- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04540484
COVID-19 IgG Formation in Physicians at ALGH and Their Household Members
14. Februar 2022 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Study is complete.
Data analysis is being put together.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
507
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Illinois
-
Park Ridge, Illinois, Vereinigte Staaten, 60068
- Advocate Lutheran General Hospital
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
Advocate Lutheran General Hospital Physicians and their household members.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
---|---|
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
Andere Namen:
|
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
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Identifying positive COVID-19 IgG formation
Zeitfenster: up to 1 year
|
up to 1 year
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Physician Prevalence of COVID-19 serum IgG
Zeitfenster: 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
Zeitfenster: 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.
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up to 1 year
|
Physician Risk of Exposure
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
PPE Use and Positivity
Zeitfenster: 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
Zeitfenster: 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.
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up to 1 year
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
26. August 2020
Primärer Abschluss (Tatsächlich)
14. Oktober 2021
Studienabschluss (Tatsächlich)
14. Dezember 2021
Studienanmeldedaten
Zuerst eingereicht
3. September 2020
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
3. September 2020
Zuerst gepostet (Tatsächlich)
7. September 2020
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
2. März 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
14. Februar 2022
Zuletzt verifiziert
1. Februar 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Coronavirus-Infektionen
- Coronaviridae-Infektionen
- Nidovirales-Infektionen
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen der Atemwege
- Erkrankungen der Atemwege
- Pneumonie, viral
- Lungenentzündung
- Lungenkrankheit
- Krankheitsattribute
- Schweres akutes respiratorisches Syndrom
- COVID-19
- Infektionen
- Übertragbare Krankheiten
Andere Studien-ID-Nummern
- 1606472-1
- M5500436 (Andere Kennung: ALGH)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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