- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Shidasp SIAMI, MD, PhD
- Telefonnummer: 0033 1 60 80 79 40
- E-mail: ssiami@ch-sudessonne.fr
Undersøgelse Kontakt Backup
- Navn: Delphine LEMAIRE-BRUNEL
- Telefonnummer: 0033 1 60 80 79 88
- E-mail: dlemaire-brunel@ch-sudessonne.fr
Studiesteder
-
-
Essonne
-
Étampes, Essonne, Frankrig, 91150
- Rekruttering
- Centre Hospitalier Sud Essonne
-
Kontakt:
- Delphine LEMAIRE-BRUNEL
- Telefonnummer: 0033 1 60 80 79 88
- E-mail: dlemaire-brunel@ch-sudessonne.fr
-
Ledende efterforsker:
- Shidasp SIAMI, MD, PhD
-
Underforsker:
- Hafida BENHABIB
-
Underforsker:
- Christine ANDREO
-
Underforsker:
- El Hadi EL GHOUATI
-
Underforsker:
- Laurence SAINSARD
-
Underforsker:
- Christelle APARICIO
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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 undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Shidasp SIAMI, MD, PhD, Centre Hospitalier Sud Essonne
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SPEED-COVID19
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .