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- Register voor klinische proeven in de VS.
- Klinische proef NCT05534009
Health Care Workers Cohort Study in the EuCARE Project (EuCARE-HCW)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Background: Protection from SARS-CoV-2 infection is known to occur soon after vaccination or natural disease, fading over time. Although protection from serious illness does occur, protection from infection is insufficient and the impact of each variant and of each vaccine or vaccine schedule is a matter of continuous study. Recruiting participants from countries with different vaccines and vaccine schedules is of upmost importance to analyse these relationships and breakthrough infections. Study objectives: The EuCARE-HCW study contributes with data and samples from
HCW to EuCARE-IMMUNITY study that will analyse the NtAb and CMI to different SARS- CoV-2 variants following any combination of natural infection and vaccination. Specific
objectives include:
- to collect data and biological material from COVID-19 healthcare workers in 9 clinics from 8 countries and 3 continents.
- Enrolment of HCW with an immunogenic event, either vaccination or infection.
- Periodic collection of serum and whole blood every 4 months since enrolment and during 12-24 months (depending on how long immunity persists).
Sample preparation, storage and shipment to central EuCARE laboratories where WP2 study group will analyse natural and artificial immunity to SARS-CoV-2 variants (EuCARE-IMMUNITY), namely:
- Analyse the magnitude, breadth and duration of immunity following natural infection and/or vaccination.
- Define the cross-immunity among the different viral variants.
- Analyse the immune escape in a comprehensive set of combinations of vaccines and natural infection(s).
To accomplish the above objectives, WP2 will test:
- Neutralising antibodies
- Cellular immunity
- Viral sequences
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studiecontact
- Naam: FRANCESCA INCARDONA, DR
- Telefoonnummer: +393356112830
- E-mail: francesca.incardona@euresist.org
Studie Locaties
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Düsseldorf, Duitsland
- Werving
- Heinrich Heine University
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Contact:
- Bjoern Erik Jensen, DR
- E-mail: Bjoern-ErikOle.Jensen@med.uni-duesseldorf.de
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Milan, Italië
- Werving
- Azienda Socio-Sanitaria Territoriale Santi Paolo e Carlo
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Contact:
- ANTONELLA D'ARMINIO MONFORTE, PROF
- Telefoonnummer: +390281843045-6
- E-mail: antonella.darminio@unimi.it
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Milan, Italië
- Werving
- IEO Istituto Europeo di Oncologia
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Contact:
- SARA GANDINI, DR
- E-mail: sara.gandini@ieo.it
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Vilnius, Litouwen
- Werving
- Viesoji Istaiga Vilniaus Uiversiteto Ligoninė Santaros klinikos
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Contact:
- DANIEL NAUMOVAS, DR
- E-mail: daniel.naumovas@santa.lt
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Villahermosa, Mexico
- Werving
- Hospital Juan Ghaham Casasus
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Contact:
- Gibran Rubio Quintanares, DR
- Telefoonnummer: +49 6103 77 2125
- E-mail: Gibran.Rubio@pei.de
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Lisbon, Portugal
- Werving
- Centro Hospitalar de Lisboa Ocidental
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Contact:
- CRISTINA TOSCANO, MD
- Telefoonnummer: +351 210432541
- E-mail: ctoscano@chlo.min-saude.pt
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Hanoi, Vietnam
- Werving
- Bach Mai Hospital
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Contact:
- CUONG DO DUY, MD
- E-mail: doduy.cuong@bachmai.edu.vn
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
For each subject baseline will be the occurrence of the first known immunization event, either natural infection or vaccination. The follow-up is planned to last 24 months with respect to this baseline.
Health CareWorkers can be enrolled in the category of:
(i) vaccination not followed by any later infection, (ii) infection followed by vaccination and (iii) vaccination followed by infection. However, infections diagnosed during the first wave of the epidemic are suitable for the analysis of natural immunity to SARS-CoV-2 because vaccination was administered several months later.
Beschrijving
Inclusion Criteria:
The study subjects will be selected based on the following inclusion criteria:
- Adult (>18 years) HCW with mandatory information on their SARS-CoV-2 infection and vaccination status.
- For those with a history of SARS-CoV-2 infection, diagnosis obtained by detection of SARS-CoV-2 RNA
- Having a signed informed consent when required by ethical approval
Exclusion Criteria: NONE
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Ander
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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Heath care workers (HCW)
Adult (>18 years) HCW with mandatory information on their SARS-CoV-2 infection and vaccination status.
For those with a history of SARS-CoV-2 infection, diagnosis obtained by detection of SARS-CoV-2 RNA
|
The baseline for enrolment into the study is defined by the occurrence of the first known immunization event, either natural infection or vaccination. The follow-up is planned to last 24 months with respect to this baseline. In subjects with natural infection, the viral variant must be determined for each prospective case by analysis of a nasopharyngeal swab obtained as soon as possible at diagnosis. For historical cases where the variant was not determined and a contemporary nasopharyngeal swab has not been stored, the viral variant may be inferred when a specific variant was dominating the geographic area according to official records available at local health agencies. However, the variant assignment will be labelled as putative, rather than proved. HCWs can be enrolled in the category of: (i) vaccination not followed by any later infection, (ii) infection followed by vaccination and (iii) vaccination followed by infection. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of HCW involved in the study
Tijdsspanne: through study completion, an average of 3 years
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To collect the higher possible number of data and biological materials from the HCWs of the participating Units
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through study completion, an average of 3 years
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: CRISTINA TOSCANO, DR, Centro Hospitalar de Lisboa Ocidental (CHLO)
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- EuCARE-HCW
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
IPD delen Ondersteunend informatietype
- Leerprotocool
- Statistisch Analyse Plan (SAP)
- Formulier voor geïnformeerde toestemming (ICF)
- Klinisch onderzoeksrapport (CSR)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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