Pandemic Triage Score in Patients With Known or Suspected Severe Acute Respiratory Syndrome (SARS) CoronaVirus (CoV) 2 Infection (STC-19)

July 6, 2022 updated by: Groupe Hospitalier de la Rochelle Ré Aunis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

91

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Rochelle, France
        • Groupe Hospitalier de la Rochelle Ré Aunis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient with COVID-19
Patient with clinical signs of CoV-2-SARS infection and signs of severity
Diagnostic test: STC-19 score
Score calculated by an algorithm using a vital sign (systolic blood pressure) and biomarkers (complete blood count with differential)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier de la Rochelle Ré Aunis

Collaborators

NumaHealth International

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

April 30, 2020

First Submitted That Met QC Criteria

April 30, 2020

First Posted (Actual)

May 1, 2020

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 6, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/P04/288

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be made available with publication and up to 15 years after the end of the study

IPD Sharing Access Criteria

A Digital Object Identifier will be provided

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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