Clinical trial NCT04381312: Direct and Indirect Impact of COVID-19 In Older Populations
Official title: COVID-19 Chez la Personne âgée de Plus de 70 Ans : Impact Direct et Indirect à 3 Mois.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Risk Factors for COVID-19 Outcomes in Elderly Populations
Keywords: elderly
COVID 19
mortality
functional status
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Older populations admitted in acute care ward for COVID 19 eor in post acute care.

Brief summary: This study propose to describe risk factors for acute and long term mortality of COVID 19 in patients up to 70 years old.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* + positive PCR confirmed COVID 19 (confirmed case) or positive Thoracic CT Scan - (probable case)

Exclusion Criteria:

* Direct admission in Intensive care.

Primary outcomes:
measure: mortality
timeFrame: 3 months
measure: Risk factors for death
timeFrame: 3 months
measure: mortality
timeFrame: 12 months
measure: Risk factors for death
timeFrame: 12 months
Secondary outcomes:
measure: Describe clinical symptoms specific to old population
timeFrame: before and at admission
measure: describe specific and non-specific treatments used for COVID 19
timeFrame: through study completion, an average of 1 year
measure: describe all acute complications
timeFrame: through study completion, an average of 1 year
measure: functional decline
timeFrame: 3 months post acute phase
measure: Rehospitalisation
timeFrame: 3 months post acute phase
measure: medical complications
timeFrame: 3 months post acute phase
measure: Admission in nursing home
timeFrame: 3 months post acute phase
measure: risk factors for 3-month functional decline, acute complication and admission to nursing home
timeFrame: 3 months post acute phase
Other outcomes:
Locations:
city: Grenoble Cedex 9
country: France
facility: Chu Grenoble Alpes
state: Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Gaetan GAVAZZI, Pr
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Seynaeve D, Augusseau-Rivière B, Couturier P, Morel-Baccard C, Landelle C, Bosson JL, Gavazzi G, Mallaret MR. J Am Med Dir Assoc. 2019 May 14 Outbreak of human metapneumovirus in a French nursing home, a retrospective study? J Am Med Dir Assoc. 2019 May 14. pii: S1525-8610(19)30302-0. doi: 10.1016/j.jamda.2019.03.015
citation: 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.
citation: 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