CT Biomarkers Identification by Artificial Intelligence for COVID-19 Prognosis (COVID 19-IA)

March 7, 2025 updated by: Centre Hospitalier Universitaire de Nīmes

Identification of Thoracic CT Scan Biomarkers by Deep Learning for Evaluating the Prognosis of Patients With COVID-19 Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France
        • CHU La Timone
      • Montpellier, France
        • CHU Montpellier
      • Nîmes, France
        • CHU de Nîmes
      • Poitiers, France
        • CHU Poitiers
      • Strasbourg, France
        • CHU Strasbourg
  • Martinique
      • Fort-de-France, Martinique
        • CHU Martinique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized for Covid-19 confirmed by RT-PCR and undergoing CT scan

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients positive for SARS-CoV-2
Diagnostic test: Imaging by thoracic scanner
Low-dose computed tomography

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vital status
Time Frame: Day 8
Dead/alive
Day 8
Patient requiring more than 3 liters of oxygen to maintain a saturation >95% (intensive care unit or resuscitation department)
Time Frame: Day 8
Yes/no
Day 8
Percentage of lung affected on CT
Time Frame: Day 0
% ground glass and condensation calculated by deep learning
Day 0
Percentage of lung affected by ground glass opacity on scan
Time Frame: Day 0
% calculated by deep learning
Day 0
Percentage of lung affected by condensation on scan
Time Frame: Day 0
% calculated by deep learning
Day 0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Vital status
Time Frame: Day 16
Dead/alive
Day 16
Vital status
Time Frame: Day 30
Dead/alive
Day 30
Length of hospitalization
Time Frame: Maximum 30 days
Days
Maximum 30 days
rehospitalization
Time Frame: Day 30
Yes/no
Day 30
Duration of intubation
Time Frame: Day 30
Days
Day 30
Percentage of lung affected on CT
Time Frame: Day 16
% ground glass and condensation calculated by deep learning
Day 16
Percentage of lung affected by ground glass opacity on scan
Time Frame: Day 16
% calculated by deep learning
Day 16
Percentage of lung affected by condensation on scan
Time Frame: Day 16
% calculated by deep learning
Day 16
Software operating time
Time Frame: End of study (August 2020)
Speed of image loading and image processing depending of brand of scanner
End of study (August 2020)
C-reactive protein levels
Time Frame: Admission Day 0
mg/L
Admission Day 0
lactate dehydrogenase
Time Frame: Admission Day 0
U/L
Admission Day 0
lymphocytemia
Time Frame: Admission Day 0
g/L
Admission Day 0
D Dimers level
Time Frame: Admission Day 0
µg/L
Admission Day 0
Time until onset of symptoms
Time Frame: Admission Day 0
Days
Admission Day 0
Time between RT-PCR positive results and first scan
Time Frame: Admission Day 0
Hours
Admission Day 0
Age
Time Frame: Admission Day 0
Years
Admission Day 0
BMI> 30
Time Frame: Admission Day 0
Yes/no:
Admission Day 0
Medical history of cardiovascular disease
Time Frame: Admission Day 0
Yes/no: hypertension, coronary artery disease, congestive heart failure, cardiac arrhythmia
Admission Day 0
Diabetes
Time Frame: Admission Day 0
Yes/no
Admission Day 0
Medical history of respiratory disease
Time Frame: Admission Day 0
Yes/no: Chronic obstructive pulmonary disease, chronic respiratory failure
Admission Day 0
Medical history of immunosuppressed condition
Time Frame: Admission Day 0
Yes/no: steroid use, pre-existing immunological condition, current chemotherapy for cancer
Admission Day 0
Current or previous history of smoking
Time Frame: Admission Day 0
Yes/no:
Admission Day 0
Calculate a prognostic score from clinical, biological and CT parameters
Time Frame: Day 8
Deep learning algorithm
Day 8
Calculate a prognostic score from clinical and biological parameters only
Time Frame: Day 8
Deep learning algorithm
Day 8
Compare receiver operating curves of prognostic scores with and without CT parameters
Time Frame: Day 8
Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Julien Frandon, CHU Nimes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2021

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIMAO/2020/COVID 19-IA/JF-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Dietary Supplements

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