Pandemic Triage Score in Patients With Known or Suspected Severe Acute Respiratory Syndrome (SARS) CoronaVirus (CoV) 2 Infection

Covid19 Clinical Trial

— STC-19  

Official title:

On-admission Multifactorial Evaluation of Inflammation as Prognostic Marker of Death in Patients Diagnosed With Coronavirus Infectious Disease (COVID-19) Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04371471
• Other study ID #: 2020/P04/288
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: April 30, 2020

Study information

• Verified date: July 2022
• Source: Groupe Hospitalier de la Rochelle Ré Aunis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Respiration Disorders
• Respiratory Tract Diseases
• SARS-CoV-2 Acute Respiratory Disease

Intervention

Diagnostic Test:
• STC-19 score
Score calculated by an algorithm using a vital sign (systolic blood pressure) and biomarkers (complete blood count with differential)

Locations

Country	Name	City	State
France	Groupe Hospitalier de la Rochelle Ré Aunis	La Rochelle

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Rochelle Ré Aunis	NumaHealth International

Country where clinical trial is conducted

France, 

References & Publications (7)

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. — View Citation

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. — View Citation

Groeneweg FL, Karst H, de Kloet ER, Joëls 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. Review. — View Citation

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 — View Citation

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. Review. — View Citation

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. Review. — View Citation

Selye H. THE SIGNIFICANCE OF THE ADRENALS FOR ADAPTATION. Science. 1937 Mar 5;85(2201):247-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Day 0
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	Day 5