Clinical trial NCT04338100: Point Of Care UltraSonography for Risk-stratification of COVID-19 Patients
Official title: Point Of Care UltraSonography to Perform Risk-stratification of Patients With Suspected or Confirmed COVID-19 - POCUSCO Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Coronavirus Infection
Keywords: COVID-19
SARS-CoV-2
POCUS
Lung ultrasonography
Risk-stratification
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-04-08
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults patients consulting emergency department with non-severe suspected or confirmed SARS-CoV-2 infection (COVID-19)

Brief summary: COVID-19 pandemic has developed worldwide in less than 4 months. While most patients have a mild or uncomplicated disease (80%), approximately 15% need hospital care and 5% intensive care. Severe cases are characterized by pulmonary involvement which may progress to acute respiratory distress syndrome (ARDS). Early identification of patients who are likely to get worse is therefore a major issue.

While, chest X-ray has poor diagnostic performances, pulmonary computed tomography (CT scan) seems very sensitive (97%) and quite specific of COVID-19. Sub-pleural bilateral ground-glass pattern can precede the positivity of RT-PCR for SARS-CoV-2. CT scan is now considered as the best imaging test to assess COVID-19 patients and is recommended as first-line diagnosis tool by the French Society of Radiology (SFR). However, performing CT scan in all or many patients with suspected COVID-19 may result in radiology department overload, especially, taking into account bio-cleaning between patients. Moreover, CT scan may lead to adverse effects including induced cancer due to the cumulative diagnostic irradiation.

Chest ultrasonography may be an alternative to CT scan. It is a simple, non-invasive, non-irradiating, inexpensive and available at the point of care (POCUS). Most of emergency physicians and many other specialists (pneumologists, infectious disease or intensive care physicians) are trained to perform chest POCUS and use it in their everyday practice. Multiple studies have demonstrated its superiority to chest X-ray for the detection of pneumonia. In ARDS, a scoring has been developed and has shown good correlation with mortality. POCUS is very effective in detecting peripheral patterns and seems appropriate to explore COVID-19 patients.

Previous studies suggest its interest in SARSCov2 infections for initial patient assessment and identification of lung damage. However, its performances have never been scientifically evaluated to date.

Our main hypothesis is that point of care lung ultrasonography performed during the initial examination may identify high-risk COVID-19 patients.

Detailed description: Patients consulting in the emergeny department of participating centres for suspected or confirmed COVID-19 are checked for inclusion and non-inclusion criteria and asked for study participation.

Including patients have point-of-care lung ultrasonography (POCUS) performed within 48 hours following ED admission. The severity of lung damage is assessed using the lung ultrasonography score on 36 points for ARDS (POCUS score).

Apart POCUS score assessment, patients are managed as usual.

If a chest CT scan is performed, its result is collected and, in particular, the quantification of the extent of pulmonary lesions in percentage from 0 to 100%, carried out according to the recommendations of the French Society of Radiology.

For hospitalized patients, if possible, a second chest ultrasonography is performed on Day 5 +/- 3. The extent of lung damage is assessed by the POCUS score.

A follow-up is carried out on day 14 (D14) and the patient's status according to the "Ordinal Scale for Clinical Improvement" for COVID-19 from WHO is recorded.

Eligibility criteria: Inclusion Criteria:

* Patient with COVID-19 confirmed by positive RT-PCR or considered as probable by the in-charge physician,
* ≥18 years old,
* Not requiring respiratory assistance and/or other intensive care
* Not subject to a limitation of active therapeutics

Exclusion Criteria:

* History of pneumonectomy
* Any reason making chest ultrasonography impossible
* Any reason making 14-day follow-up impossible
* Patient opposition to research participation.

Primary outcomes:
measure: Risk of unfavourable outcome at D14
timeFrame: 14 days
Secondary outcomes:
measure: Risk of unfavourable outcome over time
timeFrame: 14 days
measure: Risk-stratification threshold values
timeFrame: 14 days
measure: Adding value of POCUS score to previous risk-stratification clinical rules
timeFrame: 14 days
measure: POCUS score and patient clinical status at D14
timeFrame: 14 days
measure: POCUS and CT scan correlation
timeFrame: 14 days
measure: POCUS versus CT scan risk-stratification performances
timeFrame: 14 days
measure: POCUS score evolution performances
timeFrame: 14 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Florence DUPRIEZ
city: Angers
country: France
facility: MORIN François
city: Brest
country: France
facility: COUTURAUD Francis
city: Cholet
country: France
facility: BAUDIN Laure
city: Lyon
country: France
facility: TAZAROURTE Karim
city: Nantes
country: France
facility: LE CONTE Philippe
city: Poitiers
country: France
facility: MARJANOVIC Nicolas
city: Rennes
country: France
facility: SOULAT Louis
city: Rouen
country: France
facility: JOLY Luc-Marie
city: Saint-Lô
country: France
facility: DELOMAS Thomas
city: Tours
country: France
facility: FLAMENT Thomas
Study officials:
affiliation: University Hospital of Nantes
name: Philippe LE CONTE, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Tours
name: Thomas FLAMENT, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Rennes
name: Louis SOULAT, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Poitiers
name: Nicolas MARJANOVIC, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Brest
name: Francis COUTURAUD, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital of Cholet
name: Laure BAUDIN, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospices Civils de Lyon (University Hospital of Lyon)
name: Karim TAZAROURTE, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital of Saint-Lô
name: Thomas DELOMAS, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Rouen
name: Luc-Marie JOLY, Pr
role: PRINCIPAL_INVESTIGATOR
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