Senior-COVID-Rea Multicentric Survey

Study Overview
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Brief Summary
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With the spread of COVID-19 epidemic since 2019 in Wuhan, China health plans have to be adapted continuously in response to the emergency. The first publications from the Chinese experience demonstrate an increase in the incidence of COVID-19 infections in patients over 60 years of age, a higher frequency of severe forms of the disease and therefore theoretical indications of orientation towards resuscitative care. However, the first published data from Hubei province suggest a low benefit of resuscitation for patients between 70 and 80 years of age and null in patients over 80 years of age. These data question the individual benefit / risk balance of an orientation towards resuscitation for this category of patients, their quality of life and the concept of unreasonable obstinacy. Among the covariates associated with resuscitation mortality described in the data published to date, cardiovascular comorbidities, certain biological covariates (LDH, creatinine, lymphocytes, neutrophils, TP, D-dimers, etc.), the time between the first symptoms and the entry into resuscitation have been identified. The objective of this multicentric observational study is to determine the clinical and biological covariates predictive of mortality in the population of patients over 60 years of age admitted in intensive care unit, in particular by integrating functional and nutritional data from patients 1 month before COVID-19 infection.

Official Title
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A Multicentric Survey on Patients Over 60 Admitted to Intensive Care for Severe Forms of COVID Infection: Search for Prognostic Criteria Associated With Survival

Conditions
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COVID-19 Disease, Severe Form

Intervention / Treatment
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* Other: Group1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient over 60 sent to the intensive care unit whose COVID diagnosis has been established (RT-PCR and / or chest scanner) Exclusion Criteria: Refusal of the patient or his support person to participate in the study

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Group1|Comorbidities (CIRS-G scale), Functional status of the patient with Clinical frailty scale (1 month before infection) ADL score (1 month before infection) Biological data Blood group TP, D-dimers, CRP, creatinine level at the patient's entry, triglyceridemia, fibrinogen, ferritin Parameters derived from the platelet formula count on D1 of the start of intensive care (lymphocytes, neutrophils, platelets, average platelet volume, red blood cell distribution index), SYSMEX data (IG: Immature granulocytes; HFLC: high fluorescent lymphocyte count) Resuscitation outcomes LDH rate at the start of intensive care PaO2 / FiO2 ratio at the start of intensive care IGSII / SASPII score (simplified acute physiology score) on D1 of the start of intensive care SOFA score (sepsis-related organ failure assessment): a posteriori estimate based on IGSII / SASPII Delay between the appearance of the first signs of infection and admission to intensive care|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the impact of age on mortality at 30 days after admission to intensive care | First hypothesis: considering a single analysis variable (age), with expected mortality of 30% in patients under 70, and 70% in patients over 70 (with 40% of patients over 70), a total of 130 patients is necessary to show a statistically significant difference between these two groups with a power of 90% (bilateral alpha risk test of 5%). Since the multivariate analysis considers the integration of several factors, considering 15 factors, hoping for a coefficient of determination of 0.5 of the model, to achieve an optimism of less than 10%, it will be necessary to include 185 patients. After the publication of data on mortality in ICU in Lombardy region, Italy in April 2020, it was considered that a stopping of the trial at 185 patients would impair its statistical power and induce a potential risk of patients' selection bias. As a consequence the scientific committee decided that all the patients admitted to ICU until May 7th would be proposed the study. | 30 days after resuscitation admission |