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Risk Factors for COVID-19 Outcomes in Elderly PopulationsCOVID-OLDNCT04381312

Direct and Indirect Impact of COVID-19 In Older Populations

An observational study of Risk Factors for COVID-19 Outcomes in Elderly Populations, run by University Hospital, Grenoble at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 70 years and older
How many people
1,000 participants
Where
1 siteFrance
Study dates
9 Apr 2020to 9 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Older populations admitted in acute care ward for COVID 19 eor in post acute care.

Who may be able to join

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

Who cannot join

  • Direct admission in Intensive care.

Trial locations and contacts

1 site in 1 country.

Gaëtan Gavazzi, PhD Professor contact

04 76 76 5421

ggavazzi@chu-grenoble.fr

Saber Touati, ARC contact

047676

stouati1@chu-grenoble.fr

France1 site, 1 recruiting

  • Chu Grenoble Alpes

    Grenoble, Grenoble, 38043

    Recruiting

Other trials in France

About this study

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

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

Read the 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).

Keywords
elderly, COVID 19, mortality, functional status
Medical subject headings
COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mortality

    3-month survival curve

    Measured: 3 months

  2. Risk factors for death

    Specific COVID 19 risk factors for death and geriatric risk factors for death

    Measured: 3 months

  3. mortality

    12 month survival curve

    Measured: 12 months

  4. Risk factors for death

    Specific COVID 19 risk factors for death and geriatric risk factors for death

    Measured: 12 months

Secondary outcomes (8)

  1. Describe clinical symptoms specific to old population

    clinical symptoms (respiratory , non respiratory symptoms and Geriatric syndromes)

    Measured: before and at admission

  2. describe specific and non-specific treatments used for COVID 19

    Prevalence and duration of specific treatments and non-specific treatments

    Measured: through study completion, an average of 1 year

  3. 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)

    Measured: through study completion, an average of 1 year

  4. 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.

    Measured: 3 months post acute phase

  5. Rehospitalisation

    Prevalence of readmission to hospital

    Measured: 3 months post acute phase

  6. 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)

    Measured: 3 months post acute phase

  7. Admission in nursing home

    Prevalence of new nursing home admission

    Measured: 3 months post acute phase

  8. 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

    Measured: 3 months post acute phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2020
  2. Study start9 Apr 2020
  3. Primary completion9 Jul 2021 (estimated)
  4. Study completion9 Oct 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04381312
Sponsor's protocol ID
38RC20.118
Other IDs
2020-A00846-33
Acronym
COVID-OLD
Status last verified
May 2020
First submitted
10 Apr 2020
Last updated
8 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32171076

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

    PubMed 12409046

  • 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.

    PubMed 15614700

  • 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.

    PubMed 31101588

  • 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, Selimović S, Kostić D. The effect of the infection Clostridium difficile on the rehabilitation. Journal of Health Sciences 2014; 4(1): 55-8

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Risk Factors for COVID-19 Outcomes in Elderly Populations, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gaëtan Gavazzi, PhD Professor (04 76 76 5421, ggavazzi@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mortality (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04381312, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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