Clinical trial NCT04377685: Prediction of Clinical Course in COVID19 Patients
Official title: Prediction of Clinical Course in COVID19 Patients Using Unsupervised Classification Approaches of Clinical, Biological and the Multiparametric Signature of the Chest CT Scan Performed at Admission
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID 19
Keywords: COVID 19
chest CT scan
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: INSA Rennes
name: Institut National de la Santé Et de la Recherche Médicale, France
name: Centre National pour le Recherche Scientifique (CNRS)
name: Université de Lyon
name: Jean Monnet University
First posted: 2020-05-06
Enrollment: 826
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient admitted to the emergency room of COVID-19 confirmed by RT-PCR

Brief summary: In the context of the COVID19 pandemic and containment, chest CT is currently frequently performed on admission, looking for suggestive signs and basic abnormalities of COVID19 compatible viral pneumonitis pending confirmation of identification of viral RNA by reverse-transcription polymerase chain reaction(PCR), with a reported sensitivity of 56-88% in the first few days, slightly higher than PCR (60%) (1). Nevertheless, currently established radiological abnormalities are not specific for COVID19 and the specificity of the chest CT is \~25% when PCR is used as a reference (1). Deconfinement and its consequences will complicate the triage of COVID patients and the role of the scanner, with the expected impact of a decrease in the prevalence of infection in the emergency department and an increase in the number of "all-round" patients, including patients with non-COVID viral infiltrates or pneumopathies.

In addition, there are currently no imaging criteria to complement the clinical and biological data that can predict the progression of lung disease from the initial data.

Detailed description: In image processing, computational medical imaging has demonstrated its ability to predict a therapeutic response or a particular evolution after extracting relevant anatomical, functional or even non-visually perceptible information from the volume of images, making it possible to construct a powerful radiomic signature or to use robust anatomical/functional measurements to provide estimates of ventilation or vascular state. By combining these data extracted from the scanner with the standard clinical-biological data produced at admission during triage, our ambition is to build a predictive model using unsupervised classification approaches capable of helping predict clinical evolution with the aim of optimizing the management of the resource.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* clinical suspicion of COVID-19 confirmed by RT-PCR
* CT scan at ER admission
* RT-PCR sampling

Exclusion Criteria:

* CT scan failure or loss of CT data
* RT-PCR initial results unavailable

Primary outcomes:
measure: diagnostic of COVID disease composite
timeFrame: On admission to the hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Pierre CROISILLE, PhD
role: PRINCIPAL_INVESTIGATOR
References: