- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05184166
Hospital Management and 1-year Outcome of Patients Aged 70 Years and Older With Severe COVID-19 (ELDERCOV)
SARS-COV-2 infection can progress to acute respiratory distress syndrome and require hospitalization in the ICU in 5-20% of affected patients. Age is a major risk factor for developing a severe form and for death. ARDS related to SARS-COV-2 has specific features, including the need for long mechanical ventilation and length of stay and the use of corticosteroid therapy. These specificities are responsible for significant morbidity (neuromyopathy, delirium, post-resuscitation syndrome) and mortality during the first wave (46% at 3 months for the population of patients aged 70 years and over). To investigator's knowledge, no study has evaluated the prognosis in the ICU and the long-term functional outcome of elderly people admitted for a severe or critical form of COVID-19 since the major changes in management (dexamethasone, screening for thrombo-embolic complications, use of high-flow oxygen therapy as first-line treatment...).
Investigator therefore propose a 1-year follow-up of a cohort of patients aged 70 and over hospitalised in a conventional service or in intensive care for a severe or critical form of COVID-19. The objectives are to describe the prognosis and functional outcome of hospitalized elderly patients with severe COVID-19.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Le Mans, Frankrig, 72000
- Rekruttering
- Centre Hospitalier Du Mans
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- age ≥ 70 years on admission to hospital
- diagnosis of SARS-CoV-2 infection defined by a positive RT-PCR test
- medical or critical care hospitalisation between 1 July 2020 and 31 August 2021
- who experienced severe hypoxaemic acute respiratory failure defined as at least 4L/min of oxygen during hospitalisation
Exclusion Criteria:
- Oxygen therapy < 4L/min during hospitalisation
- Mc Cabe score 3 (chronic disease fatal at 1 year such as stage IV heart failure, ventilated respiratory failure, metastatic cancer, Child C cirrhosis)
- dementia or cognitive disorders before hospitalisation reported in the medical record
- patient GIR 1 to 4 before hospitalisation reported in the medical file or deduced from the description of the lifestyle
- patient with an ADL score < 4 before hospitalisation reported in the medical record or deduced from the description of lifestyle
- patient living in EHPAD before hospitalisation
- non-French speaking patient
- patient under guardianship or curatorship
- refusal to participate in the study for patients surviving 1 year or refusal by a family member or trusted person
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Mortality of patients aged 70 years and over 1 year after diagnosis of SAR-COV2 infection
Tidsramme: 6 months
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The mortality was evaluated by the proportion of patients aged 70 years and over who died 1 year after diagnosis of SARS-CoV-2 infection who had severe acute respiratory failure defined by at least 4 L/min of oxygen therapy
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6 months
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Samarbejdspartnere og efterforskere
Sponsor
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CHM-2021/S03/10
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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