Direct and Indirect Impact of COVID-19 In Older Populations (COVID-OLD)

May 7, 2020 updated by: University Hospital, Grenoble

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.

Study Overview

Status

Unknown

Conditions

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).

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Grenoble
      • Grenoble Cedex 9, Grenoble, France, 38043
        • Recruiting
        • Chu Grenoble Alpes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Direct admission in Intensive care.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: 3 months
3-month survival curve
3 months
Risk factors for death
Time Frame: 3 months
Specific COVID 19 risk factors for death and geriatric risk factors for death
3 months
mortality
Time Frame: 12 months
12 month survival curve
12 months
Risk factors for death
Time Frame: 12 months
Specific COVID 19 risk factors for death and geriatric risk factors for death
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe clinical symptoms specific to old population
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 3 months post acute phase
Prevalence of readmission to hospital
3 months post acute phase
medical complications
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Gaetan GAVAZZI, Pr, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2020

Primary Completion (Anticipated)

July 9, 2021

Study Completion (Anticipated)

October 9, 2021

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

May 7, 2020

First Posted (Actual)

May 8, 2020

Study Record Updates

Last Update Posted (Actual)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC20.118
  • 2020-A00846-33 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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