Direct and Indirect Impact of COVID-19 In Older Populations

NCT ID: NCT04381312

Last Updated: 2020-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-09
• Study Completion Date: 2021-10-09

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).

Conditions

Risk Factors for COVID-19 Outcomes in Elderly Populations

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gaetan GAVAZZI, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

Chu Grenoble Alpes

Grenoble, Grenoble, France

Site Status: RECRUITING

Countries

France

Central Contacts

Gaëtan Gavazzi, PhD Professor

Role: CONTACT

ggavazzi@chu-grenoble.fr

04 76 76 5421

Saber Touati, ARC

Role: CONTACT

stouati1@chu-grenoble.fr

047676

References

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Reference Type: BACKGROUND

PMID: 32171076 (View on PubMed)

Gavazzi G, Krause KH. Ageing and infection. Lancet Infect Dis. 2002 Nov;2(11):659-66. doi: 10.1016/s1473-3099(02)00437-1.

Reference Type: BACKGROUND

PMID: 12409046 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15614700 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 31537480 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

2020-A00846-33

Identifier Type: OTHER

Identifier Source: secondary_id

38RC20.118

Identifier Type: -

Identifier Source: org_study_id