Clinical trial NCT04327180: PREdiction of DIagnosed Covid-19 infecTion in IUC Patients
Official title: PCR-COVID-19 Predictors of Positivity in Patients Admitted to ICU for Respiratory Infection: A Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection Viral
Coronavirus
ARDS
Pneumonia
Keywords: critical care
biology of infectious agent
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The selection of patients will be carried out by a Doctor of Medicine practising within the ICU Lille Hospital taking care of patients suspected of infection with COVID-19.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: within 24 hours of admission to ICU
Secondary outcomes:
measure: Coinfections
timeFrame: during ICU stay, up to 28 days
measure: Respiratory dysfunction requiring mechanical ventilation
timeFrame: during ICU stay, up to 28 days
measure: Sequential Organ Failure Assessment (SOFA) Score
timeFrame: during ICU stay, up to 28 days
measure: SAPS II score
timeFrame: at admission
measure: Disseminated Intravascular Coagulation (DIC) score
timeFrame: during ICU stay, up to 28 days
measure: Number of days on vasopressive amines
timeFrame: during ICU stay, up to 28 days
measure: Occurrence of an event of venous or arterial thromboembolic disease
timeFrame: during ICU stay, up to 28 days
measure: Number of days with extra renal treatment (ERA)
timeFrame: during ICU stay, up to 28 days
measure: Number of patients alive after ICU stay less than 28 days will be tracked
timeFrame: At 28 day
measure: Short Form 36
timeFrame: at 9 months +/- 3 months after ICU stay
measure: Hospital anxiety and depression scale (HADS)
timeFrame: at 9 months +/- 3 months after ICU stay
measure: Impact of Event Scale - revised (IES-R)
timeFrame: at 9 months +/- 3 months after ICU stay
measure: Post-traumatic stress disorder Checklist version DSM-5 (PSL-5)
timeFrame: at 9 months +/- 3 months after ICU stay
measure: Modified Medical Research Council (MMRC) Dyspnea Scale
timeFrame: at 9 months +/- 3 months after ICU stay
measure: Correlation between number of patient deaths and all predictors for Covid-19 including anamnestic, clinical, biological, radiological parameters
timeFrame: until day 28 after admission of ICU
measure: Viral clearance
timeFrame: through study completion, an average of 28 days
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, ICU, CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: Julien Poissy, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: