Combination of Chest Scanography and Nasal Viral Detection Test to Detect COVID-19 Positive Patients Before Surgical Intervention in a University Hospital During Coronavirus Pandemia (COVID-Scan)

Evaluation of a COVID-19 Screening Strategy Combining Chest Low Dose CT and RT-PCR Test for Patients Admitted for Surgical or Interventional Procedures During the COVID 19 Outbreak

This research aims to improve the screening for COVID-19 upon admission to the Montpellier University Hospital for an act under general anesthesia or at high risk of transmission of the virus. Indeed, routine nasal swabs present many false negatives (60 to 70%) and many patients with the coronavirus have little or no symptoms. Performing a chest CT scan can reveal early signs very suggestive of viral pneumoniae due to the new coronavirus without additional risk compared to a simple chest X-ray (no injection of contrast medium, low exposure).

The objective is to assess the sensitivity of the diagnosis of COVID-19 by carrying out a nasopharyngeal RT-PCR and a low dose thoracic scanography at the hospital admission of patients scheduled to a procedure under general anesthesia or at risk of aerosolization (surgery, endoscopy, procedures involving risk of interventional radiology) in order to limit the risks of transmission to healthcare professionals or other patients and to rationalize the use of protective equipment.

This is an observational research without modification of care in the setting of COVID-19 pandemia. All clinical and biological data will be issued from routine care and medical charts. Routine use of CT scan and nasal swabs is an institutional approved strategy. Serologic tests will be performed as soon as available from serum collection collected after routine blood analysis. All data will be anonymously recorded after information and non-opposition of the patient.

Study Overview

• Status: Completed
• Conditions: COVID 19; SARS-Cov-2

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UH Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to hospital for a surgical or interventional procedure under general anesthesia or at risk of aerosolization during the COVID-19 outbreak and screened with chest CT-scan and nasopharyngeal RT-PCR to detect SARS-Cov-2 infection or carriage

Description

Inclusion criteria:

• Scheduled or unscheduled surgical or interventional procedure with at least one night in hospital
• Chest CT-scan within the first 24 hours
• Nasopharyngeal swaps within 24 hours before or after hospital admission

Exclusion criteria :

• Age under 18 years
• Patient with restriction of freedom
• Vital surgical emergency
• Direct admission to the COVID dedicated hospital
• Opposition to data utilization

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmed diagnosis of COVID-19 infection	One of the following criteria: Viral pneumonia, positive COVID-19 RT-PCR, or COVID-19 seroconversion (new onset of specific IgM or increased rate of specific IgG)	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of unexpected COVID-19 positive patients admitted to the hospital	Number of patients admitted to the hospital for an invasive procedure with COVID-19 detected by the combined strategy CT-scan plus RT-PCR at admission	24 hours from hospital admission
Number of contaminating events avoided by the early detection of COVID-19 patients	Number of events at high risk of viral transmission performed under accurate protection in COVID-19 patients detected by the early combined strategy, among hospitalization, unprotected in-hospital transportation, unprotected invasive procedure, in-bed chest X-ray, respiratory physiotherapy.	Hospital stay up to 15 days
Incidence of SARS-Cov-2 seroconversion	Modification of serologic status between hospital admission and day 15 or hospital discharge which ever occurs first.	15 days

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Philippe Gaudard, MD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 20, 2020

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Chest CT-scan; COVID-19 infection or paucy-symptomatic carriage; In-hospital screening
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: RECHMPL20_0223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No