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

• Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis (Other)
• Overall Status: Completed
• CT.gov ID: NCT04371471
• Collaborator: NumaHealth International (Other)
• Enrollment: 91
• Location: 1
• Actual Duration (Months): 2
• Patients Per Site Per Month: 46.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2 Acute Respiratory Disease; Covid19	Diagnostic Test: STC-19 score

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 Design

• Study Type: Observational
• Actual Enrollment: 91 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: On-admission Multifactorial Evaluation of Inflammation as Prognostic Marker of Death in Patients Diagnosed With Coronavirus Infectious Disease (COVID-19) Syndrome
• Actual Study Start Date: Mar 1, 2020
• Actual Primary Completion Date: Apr 30, 2020
• Actual Study Completion Date: Apr 30, 2020

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Groupe Hospitalier de la Rochelle Ré Aunis	La Rochelle		France

Sponsors and Collaborators

• Groupe Hospitalier de la Rochelle Ré Aunis
• 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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 30, 2022

More Information

Publications

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

• Responsible Party: Groupe Hospitalier de la Rochelle Ré Aunis
• ClinicalTrials.gov Identifier: NCT04371471
• Other Study ID Numbers: 2020/P04/288
• First Posted: May 1, 2020
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Respiration Disorders; Respiratory Tract Diseases

Study Results

Participant Flow

Arm/Group Title	Patient With Covid-19
Arm/Group Description	Patient with clinical signs of CoV-2-SARS infection and signs of severity STC-19 score: Score calculated by an algorithm using a vital sign (systolic blood pressure) and biomarkers (complete blood count with differential)
Period Title: Overall Study
STARTED	91
COMPLETED	81
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Patient With Covid-19
Arm/Group Description	Patient with clinical signs of CoV-2-SARS infection and signs of severity STC-19 score: Score calculated by an algorithm using a vital sign (systolic blood pressure) and biomarkers (complete blood count with differential)
Overall Participants	91
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	31 34.1%
>=65 years	60 65.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.9 (16.4)
Sex: Female, Male (Count of Participants)
Female	32 35.2%
Male	59 64.8%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
France	91 100%
Body mass index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	27.2 (5.4)
Hypertension (Count of Participants)
Count of Participants [Participants]	54 59.3%
Diabetes (Count of Participants)
Count of Participants [Participants]	67 73.6%
Chronic respiratory disease (Count of Participants)
Count of Participants [Participants]	71 78%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Normal and Above Triage (STC-19) Score
Description	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
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alive Within 29 Days of Hospitalization	Death Within 29 Days of Hospitalization
Arm/Group Description	Patients admitted through the emergency department and confirmed to be positive for SARS CoV-2. Still living at day 29 after hospitalization	Patients admitted through the emergency department and confirmed to be positive for SARS CoV-2. Death due to coronavirus disease (COVID-19) was defined as death prior to day 29. Any deaths from day 29 days onward were considered as death from complications of COVID-19.
Measure Participants	56	25
Normal value	52 57.1%	12 NaN
Above normal value	4 4.4%	5 NaN
Missing data	0 0%	8 NaN
Normal value	55 60.4%	0 NaN
Above normal value	0 0%	21 NaN
Missing data	1 1.1%	4 NaN

2. Secondary Outcome

Title	Number of Participants With Normal and Above Genito-thyroid Index (GTi) Value
Description	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
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Alive Within 29 Days of Hospitalization	Death Within 29 Days of Hospitalization
Arm/Group Description	Patients admitted through the emergency department and confirmed to be positive for SARS CoV-2. Still living at day 29 after hospitalization	Patients admitted through the emergency department and confirmed to be positive for SARS CoV-2. Death due to COVID-19 was defined as death prior to day 29. Any deaths from day 29 days onward were considered as death from complications of COVID-19.
Measure Participants	56	25
Normal value	33 36.3%	4 NaN
Above normal value	11 12.1%	10 NaN
Missing data	12 13.2%	11 NaN

Adverse Events

Time Frame	28 days
Arm/Group Title	Patient With Covid-19
Arm/Group Description	Patient with clinical signs of CoV-2-SARS infection and signs of severity STC-19 score: Score calculated by an algorithm using biomarkers
All Cause Mortality
	Patient With Covid-19
	Affected / at Risk (%)	# Events
Total	25/81 (30.9%)
Serious Adverse Events
	Patient With Covid-19
	Affected / at Risk (%)	# Events
Total	0/81 (0%)
Other (Not Including Serious) Adverse Events
	Patient With Covid-19
	Affected / at Risk (%)	# Events
Total	0/81 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.