COVID-19 Disease, Severe Form Clinical Trial
— SeniorCOVIDReaOfficial title:
A Multicentric Survey on Patients Over 60 Admitted to Intensive Care for Severe Forms of COVID Infection: Search for Prognostic Criteria Associated With Survival
| NCT number | NCT04422340 |
| Other study ID # | 69HCL20_0386 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 1, 2020 |
| Est. completion date | August 15, 2020 |
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.
| Status | Recruiting |
| Enrollment | 185 |
| Est. completion date | August 15, 2020 |
| Est. primary completion date | August 15, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Resuscitation unit at Hospital Emile Roux | Le Puy-en-Velay | |
| France | - Resuscitation unit of the Groupement Hospitalier Nord - Hospices Civils de Lyon | Lyon | |
| France | - Resuscitation unit of the Groupement Hospitalier Sud - Hospices Civils de Lyon | Lyon | |
| France | Resuscitation unit of the Groupement Hospitalier Centre - Hospices Civils de Lyon | Lyon | |
| France | Resuscitation unit of the Groupement Hospitalier Sud - Hospices Civils de Lyon | Lyon | |
| France | Service de Réanimation de l'Hôpital Nord Ouest | Villefranche-sur-Saône | |
| France | Medipole Resuscitation unit | Villeurbanne |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |