- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04381312
Direct and Indirect Impact of COVID-19 In Older Populations (COVID-OLD)
COVID-19 Chez la Personne âgée de Plus de 70 Ans : Impact Direct et Indirect à 3 Mois.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
In December 2019, Wuhan city in China, became the center of an outbreak of pneumonia due to a novel coronavirus SARS-CoV-2, which disease was named coronavirus disease 2019 (COVID19) in February, 2020, by WHO. The COVID19 is much more dangerous for people over 60 with a death rate of 3.6% after 60, 8.0% after 70 and 14.8% after 80 -and according to our Italian colleagues over 20% after 90- against 2.3% in the general population. The elderly patients exhibits more complications (ARDS, delirium, cardiac and renal insufficiency) needing intensive care, and often had multiple comorbidities and in particular: cardiovascular disease (10.5% mortality), diabetes (7.3%), chronic respiratory disease (6.3%) and hypertension (6%).
Very few data are available the specific burden of Infectious diseases (ID) in older populations. The large majority of literature is often related to intrahospital or direct mortality and only recently arise the idea of indirect impact of ID particularly in that populations. In that meaning, ID may be considered as a trigger of other medical events such as myocardial infarction, stroke, or other specific outcomes such as functional decline; For the last 10 years, the Specific interest group " GInGer "( Groupe Infectio-Geriatrique ) a network of infectiologist and geriatrician SPILF/SFGG) carried out several studies on different aspects of ID in theses populations and recently demonstrated the indirect and long term impact of influenza and Clostridioides difficile infections. As an example, In influenza study, death-rate increases from 12,2 % in hospital related death to 25% at 3 months with high rate of complications (57%), high rates of rehospitalisation (25%) and functional decline (35%) leading to high increase in nursing home admission. The cost of these indirect impact is high and underestimated.
Because of incidence and comorbidities rates, severity of the actual French older COVID 19-infected older populations and because of the potential indirect and long term impact of COVID19 in these populations, it seems essential to know whether 3 month related death is largely higher as for influenza, to determine risk factors for intra hospital and long term death, measure acute and long term complications, and describe the impact of COVID 19 on specific ageing outcomes such as functional status at Month 3 (M3).
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
-
-
Grenoble
-
Grenoble Cedex 9, Grenoble, France, 38043
- Recrutement
- CHU Grenoble Alpes
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- + positive PCR confirmed COVID 19 (confirmed case) or positive Thoracic CT Scan - (probable case)
Exclusion Criteria:
- Direct admission in Intensive care.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
mortality
Délai: 3 months
|
3-month survival curve
|
3 months
|
|
Risk factors for death
Délai: 3 months
|
Specific COVID 19 risk factors for death and geriatric risk factors for death
|
3 months
|
|
mortality
Délai: 12 months
|
12 month survival curve
|
12 months
|
|
Risk factors for death
Délai: 12 months
|
Specific COVID 19 risk factors for death and geriatric risk factors for death
|
12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Describe clinical symptoms specific to old population
Délai: before and at admission
|
clinical symptoms (respiratory , non respiratory symptoms and Geriatric syndromes)
|
before and at admission
|
|
describe specific and non-specific treatments used for COVID 19
Délai: through study completion, an average of 1 year
|
Prevalence and duration of specific treatments and non-specific treatments
|
through study completion, an average of 1 year
|
|
describe all acute complications
Délai: through study completion, an average of 1 year
|
prevalence of all medical usual complications and geriatric acquired complications, such as delirium, falls, complications, such as delirium, falls, malnutrition, pressure sore)
|
through study completion, an average of 1 year
|
|
functional decline
Délai: 3 months post acute phase
|
rates of Functional decline between basal status (before admission) and admission,and between basal and 3 months, and between Discharge and 3 month.
|
3 months post acute phase
|
|
Rehospitalisation
Délai: 3 months post acute phase
|
Prevalence of readmission to hospital
|
3 months post acute phase
|
|
medical complications
Délai: 3 months post acute phase
|
Prevalence of medical complication s ( new infectious disease, c cardiovascular, metabolic diseases and geriatric acquired complications, such as delirium, falls, complications, such as delirium, falls, malnutrition, pressure sore)
|
3 months post acute phase
|
|
Admission in nursing home
Délai: 3 months post acute phase
|
Prevalence of new nursing home admission
|
3 months post acute phase
|
|
risk factors for 3-month functional decline, acute complication and admission to nursing home
Délai: 3 months post acute phase
|
Determine risk factors for 3-month functional decline, acute complication and admission to nursing home
|
3 months post acute phase
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Gaetan GAVAZZI, Pr, University Hospital, Grenoble
Publications et liens utiles
Publications générales
- Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.
- Gavazzi G, Krause KH. Ageing and infection. Lancet Infect Dis. 2002 Nov;2(11):659-66. doi: 10.1016/s1473-3099(02)00437-1.
- High KP, Bradley S, Loeb M, Palmer R, Quagliarello V, Yoshikawa T. A new paradigm for clinical investigation of infectious syndromes in older adults: assessment of functional status as a risk factor and outcome measure. Clin Infect Dis. 2005 Jan 1;40(1):114-22. doi: 10.1086/426082. Epub 2004 Dec 6.
- Seynaeve D, Augusseau-Riviere B, Couturier P, Morel-Baccard C, Landelle C, Bosson JL, Gavazzi G, Mallaret MR. Outbreak of Human Metapneumovirus in a Nursing Home: A Clinical Perspective. J Am Med Dir Assoc. 2020 Jan;21(1):104-109.e1. doi: 10.1016/j.jamda.2019.03.015. Epub 2019 May 14.
- Caupenne A, Ingrand P, Ingrand I, Forestier E, Roubaud-Baudron C, Gavazzi G, Paccalin M. Acute Clostridioides difficile Infection in Hospitalized Persons Aged 75 and Older: 30-Day Prognosis and Risk Factors for Mortality. J Am Med Dir Assoc. 2020 Jan;21(1):110-114. doi: 10.1016/j.jamda.2019.07.002. Epub 2019 Sep 17.
- Gavazzi G, Paccalin M, de Wazieres B, Roubaud-Baudron C, Fraisse T, Bernard L, Legout L, Aquino JP, Guerin O, Forestier E, Burden of influenza in older patients over the 2016-2017 winter season in France. XXIXth ECCMID Amsterdam. (Nethderland) 2019
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 38RC20.118
- 2020-A00846-33 (Autre identifiant: ID RCB)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .