COVID-19 Disease, Severe FormSeniorCOVIDReaNCT04422340
Senior-COVID-Rea Multicentric Survey
An observational study of COVID-19 Disease, Severe Form, run by Hospices Civils de Lyon at 7 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- COVID-19 Disease, Severe Form
- What is being tested?
- Group1
- How many people
- 185 participants
- Where
- 7 sitesFrance
- Study dates
- 1 Apr 2020to 15 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient over 60 in intensive care unit for severe COVID infection
Who may be able to join
- Patient over 60
- sent to the intensive care unit
- whose COVID diagnosis has been established (RT-PCR and / or chest scanner)
Who cannot join
- Refusal of the patient or his support person to participate in the study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Resuscitation unit at Hospital Emile Roux
Le Puy-en-Velay
Claire Falandry, MD
- Recruiting
- Resuscitation unit of the Groupement Hospitalier Nord - Hospices Civils de Lyon
Lyon
Claire Falandry, MD
- Recruiting
- Resuscitation unit of the Groupement Hospitalier Sud - Hospices Civils de Lyon
Lyon
Claire Falandry, MD
- Recruiting
Resuscitation unit of the Groupement Hospitalier Centre - Hospices Civils de Lyon
Lyon
Claire Falandry, MD
- Recruiting
Resuscitation unit of the Groupement Hospitalier Sud - Hospices Civils de Lyon
Lyon
Claire Falandry, MD
- Recruiting
Service de Réanimation de l'Hôpital Nord Ouest
Villefranche-sur-Saône
Max Haine, MD
- Recruiting
Medipole Resuscitation unit
Villeurbanne, 69603
Vincent COLLANGE, MD
About this study
Official 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
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.
Read more
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.
- Conditions
- COVID-19 Disease, Severe Form
- Being tested
- Group1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group1Other
- 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after resuscitation admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Apr 2020
- Primary completion15 Aug 2020 (estimated)
- Study completion15 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Disease, Severe FormStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Falandry, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422340
- Sponsor's protocol ID
- 69HCL20_0386
- Acronym
- SeniorCOVIDRea
- Status last verified
- Jul 2020
- First submitted
- 8 Jun 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thiolliere F, Falandry C, Allaouchiche B, Geoffray V, Bitker L, Reignier J, Abraham P, Malaquin S, Balanca B, Boyer H, Seguin P, Guichon C, Simon M, Friggeri A, Vacheron CH; AZUREA Study Group. Intensive care-related loss of quality of life and autonomy at 6 months post-discharge: Does COVID-19 really make things worse? Crit Care. 2022 Apr 4;26(1):94. doi: 10.1186/s13054-022-03958-6.
PubMed 35379312Falandry C, Malapert A, Roche M, Subtil F, Berthiller J, Boin C, Dubreuil J, Ravot C, Bitker L, Abraham P, Collange V, Balanca B, Goutte S, Guichon C, Gadea E, Argaud L, Dayde D, Jallades L, Lepape A, Pialat JB, Friggeri A, Thiolliere F; Senior-COVID-Rea study Group. Risk factors associated with day-30 mortality in patients over 60 years old admitted in ICU for severe COVID-19: the Senior-COVID-Rea Multicentre Survey protocol. BMJ Open. 2021 Jul 6;11(7):e044449. doi: 10.1136/bmjopen-2020-044449.
PubMed 34230013
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04422340
- Acronym / sponsor ID
- SeniorCOVIDRea / 69HCL20_0386
- Conditions
- COVID-19 Disease, Severe Form
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 15 Aug 2020 (estimated)
- Study completion
- 15 Aug 2020 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient over 60 in intensive care unit for severe COVID infection
Key inclusion criteria (3 listed)
- Patient over 60
- sent to the intensive care unit
- whose COVID diagnosis has been established (RT-PCR and / or chest scanner)
Key exclusion criteria (1 listed)
- Refusal of the patient or his support person to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | – |
Primary outcome
Evaluation of the impact of age on mortality at 30 days after admission to intensive care
Time frame: 30 days after resuscitation admission
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Derived from this study: PubMed 35379312Thiolliere F, Falandry C, Allaouchiche B, Geoffray V, Bitker L, Reignier J, Abraham P, Malaquin S, Balanca B, Boyer H, Seguin P, Guichon C, Simon M, Friggeri A, Vacheron CH; AZUREA Study Group. Intensive care-related loss of quality of life and autonomy at 6 months post-discharge: Does COVID-19 really make things worse? Crit Care. 2022 Apr 4;26(1):94. doi: 10.1186/s13054-022-03958-6.
- Derived from this study: PubMed 34230013Falandry C, Malapert A, Roche M, Subtil F, Berthiller J, Boin C, Dubreuil J, Ravot C, Bitker L, Abraham P, Collange V, Balanca B, Goutte S, Guichon C, Gadea E, Argaud L, Dayde D, Jallades L, Lepape A, Pialat JB, Friggeri A, Thiolliere F; Senior-COVID-Rea study Group. Risk factors associated with day-30 mortality in patients over 60 years old admitted in ICU for severe COVID-19: the Senior-COVID-Rea Multicentre Survey protocol. BMJ Open. 2021 Jul 6;11(7):e044449. doi: 10.1136/bmjopen-2020-044449.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Falandry, MD principal investigator
Hospices Civils de Lyon
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Disease, Severe Form, run by Hospices Civils de Lyon at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire Falandry, MD (33 4 78 86 32 87, claire.falandry@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the impact of age on mortality at 30 days after admission to intensive care (time frame: 30 days after resuscitation admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04422340, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.