Clinical trial NCT04418245: CT Biomarkers Identification by Artificial Intelligence for COVID-19 Prognosis
Official title: Identification of Thoracic CT Scan Biomarkers by Deep Learning for Evaluating the Prognosis of Patients With COVID-19 Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Covid-19
Keywords: low dose CT scan
biomarkers
artificial intelligence
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized for Covid-19 confirmed by RT-PCR and undergoing CT scan

Brief summary: The study hypothesis is that low-dose computed tomography (LDCT) coupled with artificial intelligence by deep learning would generate imaging biomarkers linked to the patient's short- and medium-term prognosis.

The purpose of this study is to rapidly make available an early decision-making tool (from the first hospital consultation of the patient with symptoms related to SARS-CoV-2) based on the integration of several biomarkers (clinical, biological, imaging by thoracic scanner) allowing both personalized medicine and better anticipation of the patient's evolution in terms of care organization.


Eligibility criteria: Inclusion Criteria:

* Patients positive for SARS-CoV-2 according to RT-PCR test between 1st March and 31st May 2020
* Patients undergoing low dose CT scan to establish Covid-19 lung damage
* Available for at least 8 days follow-up

Exclusion Criteria:

• Patients opposing the retrospective use of their data

Primary outcomes:
measure: Vital status
timeFrame: Day 8
measure: Patient requiring more than 3 liters of oxygen to maintain a saturation >95% (intensive care unit or resuscitation department)
timeFrame: Day 8
measure: Percentage of lung affected on CT
timeFrame: Day 0
measure: Percentage of lung affected by ground glass opacity on scan
timeFrame: Day 0
measure: Percentage of lung affected by condensation on scan
timeFrame: Day 0
Secondary outcomes:
measure: Vital status
timeFrame: Day 16
measure: Vital status
timeFrame: Day 30
measure: Length of hospitalization
timeFrame: Maximum 30 days
measure: rehospitalization
timeFrame: Day 30
measure: Duration of intubation
timeFrame: Day 30
measure: Percentage of lung affected on CT
timeFrame: Day 16
measure: Percentage of lung affected by ground glass opacity on scan
timeFrame: Day 16
measure: Percentage of lung affected by condensation on scan
timeFrame: Day 16
measure: Software operating time
timeFrame: End of study (August 2020)
measure: C-reactive protein levels
timeFrame: Admission Day 0
measure: lactate dehydrogenase
timeFrame: Admission Day 0
measure: lymphocytemia
timeFrame: Admission Day 0
measure: D Dimers level
timeFrame: Admission Day 0
measure: Time until onset of symptoms
timeFrame: Admission Day 0
measure: Time between RT-PCR positive results and first scan
timeFrame: Admission Day 0
measure: Age
timeFrame: Admission Day 0
measure: BMI> 30
timeFrame: Admission Day 0
measure: Medical history of cardiovascular disease
timeFrame: Admission Day 0
measure: Diabetes
timeFrame: Admission Day 0
measure: Medical history of respiratory disease
timeFrame: Admission Day 0
measure: Medical history of immunosuppressed condition
timeFrame: Admission Day 0
measure: Current or previous history of smoking
timeFrame: Admission Day 0
measure: Calculate a prognostic score from clinical, biological and CT parameters
timeFrame: Day 8
measure: Calculate a prognostic score from clinical and biological parameters only
timeFrame: Day 8
measure: Compare receiver operating curves of prognostic scores with and without CT parameters
timeFrame: Day 8
Other outcomes:
Locations:
city: Marseille
country: France
facility: CHU la Timone
city: Montpellier
country: France
facility: CHU Montpellier
city: Nîmes
country: France
facility: CHU de Nimes
city: Poitiers
country: France
facility: CHU Poitiers
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Fort-de-France
country: Martinique
facility: CHU Martinique
Study officials:
affiliation: CHU Nimes
name: Julien Frandon
role: PRINCIPAL_INVESTIGATOR
References: