Clinical trial NCT04371471: Pandemic Triage Score in Patients With Known or Suspected Severe Acute Respiratory Syndrome (SARS) CoronaVirus (CoV) 2 Infection
Official title: On-admission Multifactorial Evaluation of Inflammation as Prognostic Marker of Death in Patients Diagnosed With Coronavirus Infectious Disease (COVID-19) Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2 Acute Respiratory Disease
Covid19
Lead sponsor: Groupe Hospitalier de la Rochelle Ré Aunis
Sponsor class: OTHER
Collaborators: name: NumaHealth International
First posted: 2020-05-01
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Normal and Above Triage (STC-19) Score
timeFrame: Day 0
Secondary outcomes:
measure: Number of Participants With Normal and Above Genito-thyroid Index (GTi) Value
timeFrame: Day 5
Other outcomes:
Locations:
city: La Rochelle
country: France
facility: Groupe Hospitalier de la Rochelle Ré Aunis
Study officials:
affiliation: Numa Health International
name: David Chalvet, MD
role: STUDY_DIRECTOR
affiliation: Numa Health International
name: Kamyar M. Hedayat, MD
role: STUDY_DIRECTOR
affiliation: Numa Health International
name: Jean-Claude Lapraz, MD
role: STUDY_DIRECTOR
affiliation: Groupe Hospitalier de la Rochelle Ré Aunis
name: Serge Bénéteaud, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
citation: 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.
citation: 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.
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.
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. eCollection 2022.