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| Name | Class |
|---|---|
| NumaHealth International | INDUSTRY |
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During this pandemic period, the goal of the health care system is to optimize the use of intensive care services for patients infected with SARS-CoV-2, given the frequency of complications that can lead to high mortality.
When patients with suspected or confirmed COVID-19 are admitted to hospital, whether or not they are symptomatic, there is currently no method to predict who will progress to complications requiring the use of intensive measures in 24-48 hours.
The body undergoes a systemic adaptation response to severe illness. Elevated cortisol and systemic inflammation are two key responses. Along with hypotension, this triad can lead to end-organ failure and death in critical illness. In critical illness, serum cortisol is dissociated from its tissular activity. We have developed a formula that calculates tissular action of cortisol called the cortisol index. It correlates in chronic ambulatory illness, and acute illness such as myocardial infarction (manuscript pending). Elevated neutrophil to lymphocyte ration (NLR) is a marker of systemic inflammation and predictor of mortality on admission to the emergency department. We have confirmed this in a retrospective and prospective study (manuscript pending, data available upon request).
The purpose of this study is to evaluate a triage score (STC-19) based on patients' biological state at the time of diagnosis, to objectively determine which patients are most likely to require intensive medical services within 24-48 hours of presentation of the emergency department.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with COVID-19 | Patient with clinical signs of CoV-2-SARS infection and signs of severity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STC-19 score | Diagnostic Test | Score calculated by an algorithm using a vital sign (systolic blood pressure) and biomarkers (complete blood count with differential) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Normal and Above Triage (STC-19) Score | Correlation between the STC-19 score based on biological measures at the time of diagnosis and patient outcome (deceased or alive within 29 days of hospitalization) The STC-19 score is based on the genito-thyroid index (GTi) calculated from the neutrophil-to-lymphocyte ratio (NLR) and the cortisol index : Normal value for cortisol range from 3 to 7 Normal value for GTi range from 1.5 to 2.5 | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Normal and Above Genito-thyroid Index (GTi) Value | Correlation between the STC-19 score based on biological measures at the time of diagnosis and patient outcome (deceased or alive within 29 days of hospitalization) The genito-thyroid index (GTi) is calculated from the neutrophil-to-lymphocyte ratio (NLR). Normal value for GTi range from 1.5 to 2.5 | Day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with clinical signs of CoV-2-SARS infection and signs of severity (polypnea, saturation < 90% room air, dyspnea, systolic blood pressure < 90 mmHg, altered consciousness, somnolence, confusion) and/or co-morbidities (> 70 years of age, Respiratory pathology at risk of decompensation, Chronic renal failure on dialysis, Heart failure or IV, Cirrhosis ≥ B, Cardiovascular history, Diabetes with poor balance or co-morbidities, Immunosuppression, Dementia)
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| Name | Affiliation | Role |
|---|---|---|
| David Chalvet, MD | Numa Health International | Study Director |
| Kamyar M. Hedayat, MD | Numa Health International | Study Director |
| Jean-Claude Lapraz, MD | Numa Health International | Study Director |
| Serge Bénéteaud, MD | Groupe Hospitalier de la Rochelle Ré Aunis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier de la Rochelle Ré Aunis | La Rochelle | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17841381 | Background | Selye H. THE SIGNIFICANCE OF THE ADRENALS FOR ADAPTATION. Science. 1937 Mar 5;85(2201):247-8. doi: 10.1126/science.85.2201.247. No abstract available. | |
| 29357129 | Background | Peeters B, Langouche L, Van den Berghe G. Adrenocortical Stress Response during the Course of Critical Illness. Compr Physiol. 2017 Dec 12;8(1):283-298. doi: 10.1002/cphy.c170022. |
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Data will be made available with publication. A Digital Object Identifier will be used. Keyword are SARS-Cov2, COVID-19, cortisol, systemic inflammation, hypotension, complete blood count.
The only available version will be the locked database. With the exception of dates, all data will be made available. Dates will only be collected to verify the quality of the clinical trial execution. They do not add to the clinical question, and may be a means of indirectly identifying patients.
The database will be made available through a secure cloud-based repository (Mendeley Data) which is an open research data repository accessible online, where researchers can upload and share their research data.
Medical Subject Headings (MESH) terms will be used to describe clinical data. Methodology for calculating the STC-19 score will be provided in the publication.
International standard unit will be used.
Data will be made available with publication and up to 15 years after the end of the study
A Digital Object Identifier will be provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient With Covid-19 | Patient with clinical signs of CoV-2-SARS infection and signs of severity STC-19 score: Score calculated by an algorithm using a vital sign (systolic blood pressure) and biomarkers (complete blood count with differential) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient With Covid-19 | Patient with clinical signs of CoV-2-SARS infection and signs of severity STC-19 score: Score calculated by an algorithm using a vital sign (systolic blood pressure) and biomarkers (complete blood count with differential) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Normal and Above Triage (STC-19) Score | Correlation between the STC-19 score based on biological measures at the time of diagnosis and patient outcome (deceased or alive within 29 days of hospitalization) The STC-19 score is based on the genito-thyroid index (GTi) calculated from the neutrophil-to-lymphocyte ratio (NLR) and the cortisol index : Normal value for cortisol range from 3 to 7 Normal value for GTi range from 1.5 to 2.5 | Posted | Count of Participants | Participants | Day 0 |
|
28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient With Covid-19 | Patient with clinical signs of CoV-2-SARS infection and signs of severity STC-19 score: Score calculated by an algorithm using biomarkers |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kamyar Hedayat | NumaHealth international | +33660404192 | khedayat@numahealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2022 | Apr 1, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 24084075 | Background | Oakley RH, Cidlowski JA. The biology of the glucocorticoid receptor: new signaling mechanisms in health and disease. J Allergy Clin Immunol. 2013 Nov;132(5):1033-44. doi: 10.1016/j.jaci.2013.09.007. Epub 2013 Sep 29. |
| 21357682 | Background | Groeneweg FL, Karst H, de Kloet ER, Joels M. Rapid non-genomic effects of corticosteroids and their role in the central stress response. J Endocrinol. 2011 May;209(2):153-67. doi: 10.1530/JOE-10-0472. Epub 2011 Feb 28. |
| 21034463 | Background | de Jager CP, van Wijk PT, Mathoera RB, de Jongh-Leuvenink J, van der Poll T, Wever PC. Lymphocytopenia and neutrophil-lymphocyte count ratio predict bacteremia better than conventional infection markers in an emergency care unit. Crit Care. 2010;14(5):R192. doi: 10.1186/cc9309. Epub 2010 Oct 29. |
| 23049706 | Background | de Jager CP, Wever PC, Gemen EF, Kusters R, van Gageldonk-Lafeber AB, van der Poll T, Laheij RJ. The neutrophil-lymphocyte count ratio in patients with community-acquired pneumonia. PLoS One. 2012;7(10):e46561. doi: 10.1371/journal.pone.0046561. Epub 2012 Oct 1. |
| 35733873 | Result | Hedayat KM, Chalvet D, Yang M, Golshan S, Allix-Beguec C, Beneteaud S, Schmit T. Evolution of Modeled Cortisol Is Prognostic of Death in Hospitalized Patients With COVID-19 Syndrome. Front Med (Lausanne). 2022 Jun 6;9:912678. doi: 10.3389/fmed.2022.912678. eCollection 2022. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Hypertension | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Chronic respiratory disease | Count of Participants | Participants |
|
Patients admitted through the emergency department and confirmed to be positive for SARS CoV-2. Death due to coronavirus disease (COVID-19) was defined as death prior to day 29. Any deaths from day 29 days onward were considered as death from complications of COVID-19. |
|
|
| Secondary | Number of Participants With Normal and Above Genito-thyroid Index (GTi) Value | Correlation between the STC-19 score based on biological measures at the time of diagnosis and patient outcome (deceased or alive within 29 days of hospitalization) The genito-thyroid index (GTi) is calculated from the neutrophil-to-lymphocyte ratio (NLR). Normal value for GTi range from 1.5 to 2.5 | Posted | Count of Participants | Participants | Day 5 |
|
|
|
| 25 |
| 81 |
| 0 |
| 81 |
| 0 |
| 81 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Missing data |
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| Missing data |
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