Direct and Indirect Impact of COVID-19 In Older Populations

Risk Factors for COVID-19 Outcomes in Elderly Populations Clinical Trial

— COVID-OLD  

Official title:

COVID-19 Chez la Personne âgée de Plus de 70 Ans : Impact Direct et Indirect à 3 Mois.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04381312
• Other study ID #: 38RC20.118
• Secondary ID: 2020-A00846-33
• Status: Recruiting
• Start date: April 9, 2020
• Est. completion date: October 9, 2021

Study information

• Verified date: May 2020
• Source: University Hospital, Grenoble
• Contact: Gaëtan Gavazzi, PhD Professor
• Phone: 04 76 76 5421
• Email: ggavazzi[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 9, 2021
• Est. primary completion date: July 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Direct admission in Intensive care.

Related Conditions & MeSH terms

• Risk Factors for COVID-19 Outcomes in Elderly Populations

Locations

Country	Name	City	State
France	Chu Grenoble Alpes	Grenoble Cedex 9	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (6)

5. 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. 2019 Sep 16. pii: S1525-8610(19)30525-0. doi: 10.1016/j.jamda.2019.07.002.Tanovic E, Tanovic H, Kadic A, Vrabac D, Selimovic S, Kostic D. The effect of the infection Clostridium difficile on the rehabilitation. Journal of Health Sciences 2014; 4(1): 55-8

Gavazzi G, Krause KH. Ageing and infection. Lancet Infect Dis. 2002 Nov;2(11):659-66. Review. — View 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

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. Epub 2004 Dec 6. — View 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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	3-month survival curve	3 months
Primary	Risk factors for death	Specific COVID 19 risk factors for death and geriatric risk factors for death	3 months
Primary	mortality	12 month survival curve	12 months
Primary	Risk factors for death	Specific COVID 19 risk factors for death and geriatric risk factors for death	12 months
Secondary	Describe clinical symptoms specific to old population	clinical symptoms (respiratory , non respiratory symptoms and Geriatric syndromes)	before and at admission
Secondary	describe specific and non-specific treatments used for COVID 19	Prevalence and duration of specific treatments and non-specific treatments	through study completion, an average of 1 year
Secondary	describe all acute complications	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
Secondary	functional decline	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
Secondary	Rehospitalisation	Prevalence of readmission to hospital	3 months post acute phase
Secondary	medical complications	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
Secondary	Admission in nursing home	Prevalence of new nursing home admission	3 months post acute phase
Secondary	risk factors for 3-month functional decline, acute complication and admission to nursing home	Determine risk factors for 3-month functional decline, acute complication and admission to nursing home	3 months post acute phase