Prediction of Clinical Course in COVID19 Patients

NCT04377685 | Completed

• 2 other identifiers: 20CH109IRBN652020/CHUSTE
• Study Type: observational
• Target: 826
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID 19

Keywords

COVID 19; chest CT scan

Outcome Measures

Primary Outcomes (1)

• diagnostic of COVID disease composite

  The diagnostoc of COVID disease is composite of: * CT features wich will include presence/location/laterality of morphological CT abonormal densities (ground glass opacities, consolidations, reticulations), * pulmonary vessels size, * distribution and abnormalities, * local / global CT-ventilation index (CT-VI) severity, * radiomic features (shape features, 1st-order and 2nd order statistics) Analysis of CT-Scan results.

  On admission to the hospital

Study Arms (1)

COVID19 patients

Patient tested positive for SARS-CoV-2 who had a CT scan

Other: CT-Scan

Interventions

CT-Scan OTHER

Chest CT scan on admission to the hospital

COVID19 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient admitted to the emergency room of COVID-19 confirmed by RT-PCR

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• INSA Rennes: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Centre National pour le Recherche Scientifique (CNRS): collaborator
• Université de Lyon: collaborator
• Jean Monnet University: collaborator

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42100, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pierre CROISILLE, PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 6, 2020
• Study Start: March 1, 2020
• Primary Completion: November 28, 2020
• Study Completion: December 26, 2020
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)