PREdiction of DIagnosed Covid-19 infecTion in IUC Patients

Study Overview
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Brief Summary
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Coronavirus 2019 (COVID-19) is a respiratory tropism virus transmitted through droplets emitted into the environment of infected persons. The symptoms can be extremely varied and the course can range from spontaneous healing without sequelae to death. Currently, the diagnosis of certainty for resuscitation patients (by definition severe) is based on searching for a fragment of virus genetic material within the epithelial cells of the respiratory tree, up and/or down, by PCR. It is to be expected that the epidemic peak will make it difficult (if not impossible) to respect the stereotypical path that is currently in place, due to the lack of space in the specific unit. This will require optimization of care pathways and use of the specific sectors. It is therefore necessary to define the simple criteria, available from the moment patients are admitted, to predict the result of the COVID-19 PCR.

Official Title
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PCR-COVID-19 Predictors of Positivity in Patients Admitted to ICU for Respiratory Infection: A Prospective Observational Cohort Study

Conditions
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Infection Viral, Coronavirus, ARDS, Pneumonia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patient admitted in ICU Lille Hospital and hospitalized in the unit Emergent Biological Risk (REB) before a suspicion of infection with COVID-19 Clinical infectious syndrome: fever (>38°C) or hypothermia ( 36°C), chill, fever at home a severe respiratory table defined by: Oxygen demand > 3 L/min in the presence of significant comorbidity (pregnancy, chronic respiratory disease, chronic heart disease, hemopathy, cirrhosis) or > 6 L/min in the absence of comorbidity or a respiratory rate > 30 cycles per minute the need for mechanical, invasive or non-invasive ventilation the need for humidified high-flow oxygen therapy Exclusion Criteria: Patient already included in study for first stay Cirrhosis CHILD C Major surgery in the last 7 days Minor patient Patient under guardianship or curatorship Refusal to participate No social security coverage.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients suspected of infection with COVID-19.<br>Patients included with positive PCR and patients with negative PCR included | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between nasal and deep PCR positivity for Covid-19 patients performed and all predictors for Covid-19 patients performed within 24 hours of admission to ICU |  | within 24 hours of admission to ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coinfections | Assessment of viral, bacterial, fungal and parasitic rate in confirmed and unconfirmed patients for COVID-19 | during ICU stay, up to 28 days | 
| Respiratory dysfunction requiring mechanical ventilation | it will be reported the evolution of respiratory dysfunction in patients infected with COVID-19 admitted to ICU during their stay and requiring mechanical ventilation (during, Pao2/FIO2 ratio,,features of artificial ventilation features of extra-bodied respiratory assistance) | during ICU stay, up to 28 days | 
| Sequential Organ Failure Assessment (SOFA) Score | the SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure). | during ICU stay, up to 28 days | 
| SAPS II score | APS II was designed to measure the severity of disease for patients admitted to Intensive care units 24 hours after admission to the ICU, the measurement has been completed and resulted in an integer point score between 0 and 163 and a predicted mortality between 0% and 100%. | at admission | 
| Disseminated Intravascular Coagulation (DIC) score | The DIC Score was developed by the The International Society of Thrombosis and Haemostasis (ISTH.) The DIC score calculator accounts of the following four parameters.Each of the four parameters evaluated above have values that are weighted with a number of points varying from 0 to 3. By summing the points given to the choices, a final result between 0 and 8 is obtained | during ICU stay, up to 28 days | 
| Number of days on vasopressive amines |  | during ICU stay, up to 28 days | 
| Occurrence of an event of venous or arterial thromboembolic disease |  | during ICU stay, up to 28 days | 
| Number of days with extra renal treatment (ERA) |  | during ICU stay, up to 28 days | 
| Number of patients alive after ICU stay less than 28 days will be tracked |  | At 28 day | 
| Short Form 36 | measuring the long-term impact of confirmed COVID-19 infection. assessment of quality of life according to 8 areas: physical activity (and related limitations), body pain, perception of one's own health, mental health (and related limitations), social life and vitality. | at 9 months +/- 3 months after ICU stay | 
| Hospital anxiety and depression scale (HADS) | The scale allows to detect anxiety and depression using 14 items rated from 0-3. Measuring the long-term impact of confirmed COVID-19 infection | at 9 months +/- 3 months after ICU stay | 
| Impact of Event Scale - revised (IES-R) | 22-item self-report measure that assesses subjective distress caused by traumatic events Items are rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The IES-R yields a total score (ranging from 0 to 88) Measuring the long-term impact of confirmed COVID-19 infection | at 9 months +/- 3 months after ICU stay | 
| Post-traumatic stress disorder Checklist version DSM-5 (PSL-5) | Question the stressful experience or event, followed by 20 multiple-choice questions. Measuring the long-term impact of confirmed COVID-19 infection | at 9 months +/- 3 months after ICU stay | 
| Modified Medical Research Council (MMRC) Dyspnea Scale | The mMRC Dyspnea Scale stratifies severity of dyspnea in respiratory diseases Measuring the long-term impact of confirmed COVID-19 infection | at 9 months +/- 3 months after ICU stay | 
| Correlation between number of patient deaths and all predictors for Covid-19 including anamnestic, clinical, biological, radiological parameters |  | until day 28 after admission of ICU | 
| Viral clearance | Evolution of viral clearance in nasal and depp PCR during ICU | through study completion, an average of 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critical care, biology of infectious agent