Covid19, SARS-CoV-2 Acute Respiratory Disease
Conditions
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.
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.
Interventions
DIAGNOSTIC_TESTSTC-19 score
Score calculated by an algorithm using a vital sign (systolic blood pressure) and biomarkers (complete blood count with differential)
Sponsors
NumaHealth International
Groupe Hospitalier de la Rochelle Ré Aunis
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient With Covid-19 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) | 91 |
| Total | 91 |
Baseline characteristics
| Characteristic | Patient With Covid-19 | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 60 Participants | — |
| Age, Categorical Between 18 and 65 years | 31 Participants | — |
| Age, Continuous | 69.9 years STANDARD_DEVIATION 16.4 | — |
| Body mass index | 27.2 kg/m^2 STANDARD_DEVIATION 5.4 | — |
| Chronic respiratory disease | 71 Participants | — |
| Diabetes | 67 Participants | — |
| Hypertension | 54 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 91 participants | — |
| Sex: Female, Male Female | 32 Participants | — |
| Sex: Female, Male Male | 59 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 25 / 81 |
| other Total, other adverse events | 0 / 81 |
| serious Total, serious adverse events | 0 / 81 |
Outcome results
Primary
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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Alive Within 29 Days of Hospitalization | Number of Participants With Normal and Above Triage (STC-19) Score | Genito-thyroid index | Normal value | 52 Participants |
| Alive Within 29 Days of Hospitalization | Number of Participants With Normal and Above Triage (STC-19) Score | Genito-thyroid index | Above normal value | 4 Participants |
| Alive Within 29 Days of Hospitalization | Number of Participants With Normal and Above Triage (STC-19) Score | Genito-thyroid index | Missing data | 0 Participants |
| Alive Within 29 Days of Hospitalization | Number of Participants With Normal and Above Triage (STC-19) Score | Cortisol index adjusted | Normal value | 55 Participants |
| Alive Within 29 Days of Hospitalization | Number of Participants With Normal and Above Triage (STC-19) Score | Cortisol index adjusted | Above normal value | 0 Participants |
| Alive Within 29 Days of Hospitalization | Number of Participants With Normal and Above Triage (STC-19) Score | Cortisol index adjusted | Missing data | 1 Participants |
| Death Within 29 Days of Hospitalization | Number of Participants With Normal and Above Triage (STC-19) Score | Cortisol index adjusted | Above normal value | 21 Participants |
| Death Within 29 Days of Hospitalization | Number of Participants With Normal and Above Triage (STC-19) Score | Genito-thyroid index | Normal value | 12 Participants |
| Death Within 29 Days of Hospitalization | Number of Participants With Normal and Above Triage (STC-19) Score | Cortisol index adjusted | Normal value | 0 Participants |
| Death Within 29 Days of Hospitalization | Number of Participants With Normal and Above Triage (STC-19) Score | Genito-thyroid index | Above normal value | 5 Participants |
| Death Within 29 Days of Hospitalization | Number of Participants With Normal and Above Triage (STC-19) Score | Cortisol index adjusted | Missing data | 4 Participants |
| Death Within 29 Days of Hospitalization | Number of Participants With Normal and Above Triage (STC-19) Score | Genito-thyroid index | Missing data | 8 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Alive Within 29 Days of Hospitalization | Number of Participants With Normal and Above Genito-thyroid Index (GTi) Value | Normal value | 33 Participants |
| Alive Within 29 Days of Hospitalization | Number of Participants With Normal and Above Genito-thyroid Index (GTi) Value | Above normal value | 11 Participants |
| Alive Within 29 Days of Hospitalization | Number of Participants With Normal and Above Genito-thyroid Index (GTi) Value | Missing data | 12 Participants |
| Death Within 29 Days of Hospitalization | Number of Participants With Normal and Above Genito-thyroid Index (GTi) Value | Normal value | 4 Participants |
| Death Within 29 Days of Hospitalization | Number of Participants With Normal and Above Genito-thyroid Index (GTi) Value | Above normal value | 10 Participants |
| Death Within 29 Days of Hospitalization | Number of Participants With Normal and Above Genito-thyroid Index (GTi) Value | Missing data | 11 Participants |