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

SARS-Cov-2 Clinical Trial

— COVID-Scan  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04355715
• Other study ID #: RECHMPL20_0223
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: October 20, 2020

Study information

• Verified date: December 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 20, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID 19
• SARS-Cov-2

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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