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OpenTrials
Completed

NCT Number: NCT04371471

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

STC-19 score

Diagnostic Test

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

Primary outcomes

  1. Number of Participants With Normal and Above Triage (STC-19) Score

    Time frame: Day 0

    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

Secondary outcomes

  1. Number of Participants With Normal and Above Genito-thyroid Index (GTi) Value

    Time frame: Day 5

    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

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Rochelle Ré Aunis

Other

Collaborators

  • NumaHealth International

Registry information

Official study title

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

Acronym: STC-19

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 1, 2020
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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