Pandemic Triage Score in Patients With Known or Suspected Severe Acute Respiratory Syndrome (SARS) CoronaVirus (CoV) 2 Infection
STC-19
On-admission Multifactorial Evaluation of Inflammation as Prognostic Marker of Death in Patients Diagnosed With Coronavirus Infectious Disease (COVID-19) Syndrome
1 other identifier
observational
91
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedFirst Posted
Study publicly available on registry
May 1, 2020
CompletedResults Posted
Study results publicly available
April 7, 2022
CompletedJuly 19, 2022
July 1, 2022
2 months
April 30, 2020
February 24, 2022
July 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Number of Participants With Normal and Above Genito-thyroid Index (GTi) Value
Day 5
Study Arms (1)
Patient with COVID-19
Patient with clinical signs of CoV-2-SARS infection and signs of severity
Interventions
Score calculated by an algorithm using a vital sign (systolic blood pressure) and biomarkers (complete blood count with differential)
Eligibility Criteria
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)
You may qualify if:
- Patient with clinical signs of CoV-2-SARS infection
- Complete blood count test and systolic blood pressure available at the time of diagnosis
- Informed of the study.
You may not qualify if:
- Women beyond the 1st trimester of pregnancy
- Persons under-the-age-of or legally-denied medical decision-making capacity by a judicial or administrative decision,
- Persons of full age who are subject to a legal protection measure,
- Persons unable to consent,
- Persons who are not members of or beneficiaries of a social welfare program administered by the Republic of France
- Patient's refusal to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle, France
Related Publications (7)
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.
PMID: 17841381BACKGROUNDPeeters 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.
PMID: 29357129BACKGROUNDOakley 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.
PMID: 24084075BACKGROUNDGroeneweg 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.
PMID: 21357682BACKGROUNDde 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.
PMID: 21034463BACKGROUNDde 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.
PMID: 23049706BACKGROUNDHedayat 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.
PMID: 35733873RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Kamyar Hedayat
- Organization
- NumaHealth international
Study Officials
- STUDY DIRECTOR
David Chalvet, MD
Numa Health International
- STUDY DIRECTOR
Kamyar M. Hedayat, MD
Numa Health International
- STUDY DIRECTOR
Jean-Claude Lapraz, MD
Numa Health International
- PRINCIPAL INVESTIGATOR
Serge Bénéteaud, MD
Groupe Hospitalier de la Rochelle Ré Aunis
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2020
First Posted
May 1, 2020
Study Start
March 1, 2020
Primary Completion
April 30, 2020
Study Completion
April 30, 2020
Last Updated
July 19, 2022
Results First Posted
April 7, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- Data will be made available with publication and up to 15 years after the end of the study
- Access Criteria
- A Digital Object Identifier will be provided
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.