- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04872699
Prevalence of COVID-19 in a French Dependent Care Facility for the Elderly and in a French Long-term Care Unit: Observational Study (SPEED-COVID)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Among people exposed to the COVID-19 (SARS-COV-2) pandemic, elderly people are considered as particularly vulnerable, especially those living in nursing homes or hospitalized. Furthermore, facilities / accommodations are registered among the main locations of COVID-19 clusters.
These observations have led the French government to establish specific protection measures and survey dependent care facilities for the elderly and long-term care units in the hospital.
With these new standards established, a long-term study of all the residents and geriatric inpatients of the care facilities attached to the Centre Hospitalier Sud Essonne (a general hospital located in Ile-de-France, France), can provide additional knowledge on COVID-19.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Shidasp SIAMI, MD, PhD
- Telefonnummer: 0033 1 60 80 79 40
- E-post: ssiami@ch-sudessonne.fr
Studer Kontakt Backup
- Navn: Delphine LEMAIRE-BRUNEL
- Telefonnummer: 0033 1 60 80 79 88
- E-post: dlemaire-brunel@ch-sudessonne.fr
Studiesteder
-
-
Essonne
-
Étampes, Essonne, Frankrike, 91150
- Rekruttering
- Centre Hospitalier Sud Essonne
-
Ta kontakt med:
- Delphine LEMAIRE-BRUNEL
- Telefonnummer: 0033 1 60 80 79 88
- E-post: dlemaire-brunel@ch-sudessonne.fr
-
Hovedetterforsker:
- Shidasp SIAMI, MD, PhD
-
Underetterforsker:
- Hafida BENHABIB
-
Underetterforsker:
- Christine ANDREO
-
Underetterforsker:
- El Hadi EL GHOUATI
-
Underetterforsker:
- Laurence SAINSARD
-
Underetterforsker:
- Christelle APARICIO
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- residents of the dependant care facility for the elderly
- inpatients of the long-term care unit
- from march, 2020 to december, 2021
Exclusion Criteria:
- opposition to participate in this study
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
General prevalence of COVID-19
Tidsramme: Through the study completion, an average of 12 months
|
measures the prevalence of COVID-19 among the residents and geriatric inpatients, defined as resident and patients with positive serologic or RT-PCR test
|
Through the study completion, an average of 12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of asymptomatic residents/inpatients
Tidsramme: Through study completion, an average of 12 months
|
|
Through study completion, an average of 12 months
|
Number of symptomatic residents/inpatients
Tidsramme: Through study completion, an average of 12 months
|
Positive RT-PCR test or serologic test with symptoms
|
Through study completion, an average of 12 months
|
Number of residents/inpatients with severe form of COVID-19 which led to an hospitalization
Tidsramme: Through study completion, an average of 12 months
|
Positive RT-PCR test or serologic test and hospitalization
|
Through study completion, an average of 12 months
|
Number of residents/inpatients infected with COVID-19 and hospitalized in a critical care unit
Tidsramme: Through study completion, an average of 12 months
|
Positive RT-PCR test or serologic test and hospitalization in critical care unit
|
Through study completion, an average of 12 months
|
Number of residents/inpatients infected with COVID-19 and deceased
Tidsramme: Through study completion, an average of 12 months
|
Positive RT-PCR test or serologic test and deceased
|
Through study completion, an average of 12 months
|
Number of residents/inpatients vaccinated against COVID-19
Tidsramme: Through study completion, an average of 12 months
|
Positive RT-PCR test or serologic test and vaccinated with any authorized vaccine
|
Through study completion, an average of 12 months
|
Influencing factors of the prevalence of COVID-19 among residents/inpatients
Tidsramme: Through study completion, an average of 12 months
|
|
Through study completion, an average of 12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Shidasp SIAMI, MD, PhD, Centre Hospitalier Sud Essonne
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SPEED-COVID19
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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