NCT04418245

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2020

Geographic Reach
2 countries

6 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

June 4, 2020

Last Update Submit

March 7, 2025

Conditions

Keywords

low dose CT scanbiomarkersartificial intelligence

Outcome Measures

Primary Outcomes (5)

  • Vital status

    Dead/alive

    Day 8

  • Patient requiring more than 3 liters of oxygen to maintain a saturation >95% (intensive care unit or resuscitation department)

    Yes/no

    Day 8

  • Percentage of lung affected on CT

    % ground glass and condensation calculated by deep learning

    Day 0

  • Percentage of lung affected by ground glass opacity on scan

    % calculated by deep learning

    Day 0

  • Percentage of lung affected by condensation on scan

    % calculated by deep learning

    Day 0

Secondary Outcomes (25)

  • Vital status

    Day 16

  • Vital status

    Day 30

  • Length of hospitalization

    Maximum 30 days

  • rehospitalization

    Day 30

  • Duration of intubation

    Day 30

  • +20 more secondary outcomes

Study Arms (1)

Patients positive for SARS-CoV-2

Diagnostic Test: Imaging by thoracic scanner

Interventions

Low-dose computed tomography

Patients positive for SARS-CoV-2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Patients opposing the retrospective use of their data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHU la Timone

Marseille, France

Location

CHU Montpellier

Montpellier, France

Location

CHU de Nimes

Nîmes, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Strasbourg

Strasbourg, France

Location

CHU Martinique

Fort-de-France, Martinique

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Julien Frandon

    CHU Nimes

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2020

First Posted

June 5, 2020

Study Start

March 1, 2020

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

March 10, 2025

Record last verified: 2025-03

Locations