Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04381312
Recruitment Status : Recruiting
First Posted : May 8, 2020
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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.

Condition or disease
Risk Factors for COVID-19 Outcomes in Elderly Populations

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).

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVID-19 Chez la Personne âgée de Plus de 70 Ans : Impact Direct et Indirect à 3 Mois.
Actual Study Start Date : April 9, 2020
Estimated Primary Completion Date : July 9, 2021
Estimated Study Completion Date : October 9, 2021



Primary Outcome Measures :
  1. mortality [ Time Frame: 3 months ]
    3-month survival curve

  2. Risk factors for death [ Time Frame: 3 months ]
    Specific COVID 19 risk factors for death and geriatric risk factors for death

  3. mortality [ Time Frame: 12 months ]
    12 month survival curve

  4. Risk factors for death [ Time Frame: 12 months ]
    Specific COVID 19 risk factors for death and geriatric risk factors for death


Secondary Outcome Measures :
  1. Describe clinical symptoms specific to old population [ Time Frame: before and at admission ]
    clinical symptoms (respiratory , non respiratory symptoms and Geriatric syndromes)

  2. 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

  3. 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)

  4. 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.

  5. Rehospitalisation [ Time Frame: 3 months post acute phase ]
    Prevalence of readmission to hospital

  6. 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)

  7. Admission in nursing home [ Time Frame: 3 months post acute phase ]
    Prevalence of new nursing home admission

  8. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Older populations admitted in acute care ward for COVID 19 eor in post acute care.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Direct admission in Intensive care.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04381312


Contacts
Layout table for location contacts
Contact: Gaëtan Gavazzi, PhD Professor 04 76 76 5421 ggavazzi@chu-grenoble.fr
Contact: Saber Touati, ARC 047676 stouati1@chu-grenoble.fr

Locations
Layout table for location information
France
Chu Grenoble Alpes Recruiting
Grenoble Cedex 9, Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Layout table for investigator information
Principal Investigator: Gaetan GAVAZZI, Pr University Hospital, Grenoble
Publications:
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
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

Layout table for additonal information
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04381312    
Other Study ID Numbers: 38RC20.118
2020-A00846-33 ( Other Identifier: ID RCB )
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
elderly
COVID 19
mortality
functional status