SARS-CoV-2 Acute Respiratory DiseaseSTC-19NCT04371471
Pandemic Triage Score in Patients With Known or Suspected Severe Acute Respiratory Syndrome (SARS) CoronaVirus (CoV) 2 Infection
An observational study of SARS-CoV-2 Acute Respiratory Disease and Covid19, run by Groupe Hospitalier de la Rochelle Ré Aunis at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2 Acute Respiratory Disease, Covid19
- What is being tested?
- STC-19 score
- How many people
- 91 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 30 Apr 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- SARS-CoV-2 Acute Respiratory Disease, Covid19
- Being tested
- STC-19 score
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STC-19 scoreDiagnostic test
Score calculated by an algorithm using a vital sign (systolic blood pressure) and biomarkers (complete blood count with differential)
| Study group | Role | What they receive |
|---|---|---|
| Patient with COVID-19 | Patient with clinical signs of CoV-2-SARS infection and signs of severity Receives: Diagnostic Test: STC-19 score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Normal and Above Triage (STC-19) Score
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
Measured: Day 0
Secondary outcomes (1)
Number of Participants With Normal and Above Genito-thyroid Index (GTi) Value
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
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start1 Mar 2020
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 Acute Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
- Sponsor type
- University, hospital or other
- Collaborators
- NumaHealth International
- Responsible party
- Sponsor
- Investigators
- David Chalvet, MD, Study director, Numa Health InternationalKamyar M. Hedayat, MD, Study director, Numa Health InternationalJean-Claude Lapraz, MD, Study director, Numa Health InternationalSerge Bénéteaud, MD, Principal investigator, Groupe Hospitalier de la Rochelle Ré Aunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371471
- Sponsor's protocol ID
- 2020/P04/288
- Acronym
- STC-19
- Status last verified
- Jul 2022
- First submitted
- 30 Apr 2020
- Last updated
- 19 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 17841381Peeters 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.
PubMed 29357129Oakley 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.
PubMed 24084075Groeneweg 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.
PubMed 21357682de 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.
PubMed 21034463de 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.
PubMed 23049706Hedayat 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.
PubMed 35733873
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On-admission Multifactorial Evaluation of Inflammation as Prognostic Marker of Death in Patients Diagnosed With Coronavirus Infectious Disease (COVID-19) Syndrome
- ClinicalTrials.gov ID
- NCT04371471
- Acronym / sponsor ID
- STC-19 / 2020/P04/288
- Conditions
- SARS-CoV-2 Acute Respiratory Disease, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré AunisUniversity, hospital or other
- Collaborators
- NumaHealth International
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 1 May 2020 (actual)
- Results
- Posted 7 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with COVID-19 | – | Diagnostic Test: STC-19 scorePatient with clinical signs of CoV-2-SARS infection and signs of severity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STC-19 scoreScore calculated by an algorithm using a vital sign (systolic blood pressure) and biomarkers (complete blood count with differential) | Diagnostic test | Patient with COVID-19 |
Primary outcome
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
1 secondary outcome
Number of Participants With Normal and Above Genito-thyroid Index (GTi) Value
Time frame: Day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17841381Selye 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.
- Background: PubMed 29357129Peeters 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.
- Background: PubMed 24084075Oakley 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.
- Background: PubMed 21357682Groeneweg 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.
- Background: PubMed 21034463de 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.
- Background: PubMed 23049706de 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.
- Results publication: PubMed 35733873Hedayat 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Chalvet, MD study director
Numa Health International
Kamyar M. Hedayat, MD study director
Numa Health International
Jean-Claude Lapraz, MD study director
Numa Health International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 Acute Respiratory Disease and Covid19, run by Groupe Hospitalier de la Rochelle Ré Aunis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Normal and Above Triage (STC-19) Score (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04371471, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.