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

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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

Tracking Information
First Submitted Date April 10, 2020
First Posted Date May 8, 2020
Last Update Posted Date May 8, 2020
Actual Study Start Date April 9, 2020
Estimated Primary Completion Date July 9, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2020)
  • mortality [ Time Frame: 3 months ]
    3-month survival curve
  • Risk factors for death [ Time Frame: 3 months ]
    Specific COVID 19 risk factors for death and geriatric risk factors for death
  • mortality [ Time Frame: 12 months ]
    12 month survival curve
  • Risk factors for death [ Time Frame: 12 months ]
    Specific COVID 19 risk factors for death and geriatric risk factors for death
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 7, 2020)
  • Describe clinical symptoms specific to old population [ Time Frame: before and at admission ]
    clinical symptoms (respiratory , non respiratory symptoms and Geriatric syndromes)
  • 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
  • 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)
  • 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.
  • Rehospitalisation [ Time Frame: 3 months post acute phase ]
    Prevalence of readmission to hospital
  • 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)
  • Admission in nursing home [ Time Frame: 3 months post acute phase ]
    Prevalence of new nursing home admission
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Direct and Indirect Impact of COVID-19 In Older Populations
Official Title COVID-19 Chez la Personne âgée de Plus de 70 Ans : Impact Direct et Indirect à 3 Mois.
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).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Older populations admitted in acute care ward for COVID 19 eor in post acute care.
Condition Risk Factors for COVID-19 Outcomes in Elderly Populations
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 7, 2020)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 9, 2021
Estimated Primary Completion Date July 9, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 70 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Gaëtan Gavazzi, PhD Professor 04 76 76 5421 ggavazzi@chu-grenoble.fr
Contact: Saber Touati, ARC 047676 stouati1@chu-grenoble.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04381312
Other Study ID Numbers 38RC20.118
2020-A00846-33 ( Other Identifier: ID RCB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University Hospital, Grenoble
Study Sponsor University Hospital, Grenoble
Collaborators Not Provided
Investigators
Principal Investigator: Gaetan GAVAZZI, Pr University Hospital, Grenoble
PRS Account University Hospital, Grenoble
Verification Date May 2020