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COVID-Scan: 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

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04355715
Collaborator
(none)
200
Enrollment
1
Location
18.7
Actual Duration (Months)
10.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Apr 1, 2019
    Actual Primary Completion Date :
    Oct 1, 2020
    Actual Study Completion Date :
    Oct 20, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Confirmed diagnosis of COVID-19 infection [15 days]

      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)

    Secondary Outcome Measures

    1. Incidence of unexpected COVID-19 positive patients admitted to the hospital [24 hours from hospital admission]

      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

    2. Number of contaminating events avoided by the early detection of COVID-19 patients [Hospital stay up to 15 days]

      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.

    3. Incidence of SARS-Cov-2 seroconversion [15 days]

      Modification of serologic status between hospital admission and day 15 or hospital discharge which ever occurs first.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uh Montpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04355715
    Other Study ID Numbers:
    • RECHMPL20_0223
    First Posted:
    Apr 21, 2020
    Last Update Posted:
    Dec 29, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    COVID-19 infection or paucy-symptomatic carriage
    In-hospital screening
    Chest CT-scan
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Dec 29, 2020