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

NCT ID: NCT04371471

Last Updated: 2022-07-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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SARS-CoV-2 Acute Respiratory Disease Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patient with COVID-19

Patient with clinical signs of CoV-2-SARS infection and signs of severity

STC-19 score

Intervention Type DIAGNOSTIC_TEST

Score calculated by an algorithm using a vital sign (systolic blood pressure) and biomarkers (complete blood count with differential)

Interventions

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STC-19 score

Score calculated by an algorithm using a vital sign (systolic blood pressure) and biomarkers (complete blood count with differential)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NumaHealth International

INDUSTRY

Sponsor Role collaborator

Groupe Hospitalier de la Rochelle Ré Aunis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Chalvet, MD

Role: STUDY_DIRECTOR

Numa Health International

Kamyar M. Hedayat, MD

Role: STUDY_DIRECTOR

Numa Health International

Jean-Claude Lapraz, MD

Role: STUDY_DIRECTOR

Numa Health International

Serge Bénéteaud, MD

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier de la Rochelle Ré Aunis

Locations

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Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 17841381 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29357129 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24084075 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21357682 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21034463 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23049706 (View on PubMed)

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.

Reference Type RESULT
PMID: 35733873 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2020/P04/288

Identifier Type: -

Identifier Source: org_study_id

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