An observational study in SARS-CoV-2 Acute Respiratory Disease and Covid19, sponsored by Groupe Hospitalier de la Rochelle Ré Aunis. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-19.
Sponsored by Groupe Hospitalier de la Rochelle Ré Aunis · Observational
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 91 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Groupe Hospitalier de la Rochelle Ré Aunis is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
Exclusion Criteria:
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)
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
Time frame: Day 0
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
Time frame: Day 5
| Milestone | Patient With Covid-19 |
|---|---|
| Started | 91 |
| Completed | 81 |
| Not completed | 10 |
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
| Participants | Alive Within 29 Days of Hospitalization | Death Within 29 Days of Hospitalization |
|---|---|---|
| Genito-thyroid index — Normal value | 52 | 12 |
| Genito-thyroid index — Above normal value | 4 | 5 |
| Genito-thyroid index — Missing data | 0 | 8 |
| Cortisol index adjusted — Normal value | 55 | 0 |
| Cortisol index adjusted — Above normal value | 0 | 21 |
| Cortisol index adjusted — Missing data | 1 | 4 |
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
| Participants | Alive Within 29 Days of Hospitalization | Death Within 29 Days of Hospitalization |
|---|---|---|
| Normal value | 33 | 4 |
| Above normal value | 11 | 10 |
| Missing data | 12 | 11 |
Collected over 28 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patient With Covid-19 | 25/81 (30.9%) | 0/81 (0%) | 0/81 (0%) |
| Age, Categorical(Participants) | Patient With Covid-19 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 31 |
| >=65 years | 60 |
| Age, Continuous(years) | Patient With Covid-19 |
|---|---|
| Mean | 69.9 ± 16.4 |
| Sex: Female, Male(Participants) | Patient With Covid-19 |
|---|---|
| Female | 32 |
| Male | 59 |
| Race and Ethnicity Not Collected(Participants) | Patient With Covid-19 |
|---|
| Region of Enrollment(participants) | Patient With Covid-19 |
|---|---|
| France | 91 |
| Body mass index(kg/m^2) | Patient With Covid-19 |
|---|---|
| Mean | 27.2 ± 5.4 |
| Hypertension(Participants) | Patient With Covid-19 |
|---|---|
| Count of participants | 54 |
| Diabetes(Participants) | Patient With Covid-19 |
|---|---|
| Count of participants | 67 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Csr
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Groupe Hospitalier de la Rochelle Ré Aunis