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2019-nCoV (COVID-19)eChoVidNCT04335019

Interest of the Use of Pulmonary Ultrasound in the Referral of Patients With or Suspected COVID-19 +

An observational study of 2019-nCoV (COVID-19) and Interstitial Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The recent pandemic due to the SARS-CoV2 results in a pulmonary infection in major symptomatic patients. Because of the large number of patients and the risk of acute respiratory distress syndrome (which seems to occur in almost 5% of patients), there is a real challenge to improve physician ability to screen between… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
2019-nCoV (COVID-19), Interstitial Pneumonia
What is being tested?
Pulmonary ultrasound
How many people
328 participants
Where
1 siteFrance
Study dates
2 Apr 2020to 26 May 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Suspected of COVID-19 infection or having a systematic COVID-19 screening

Who may be able to join

  • > 18 years old
  • Suspected of COVID-19 infection or having a systematic COVID-19 screening

Who cannot join

  • Patients on whom the ultrasonographic examination is not feasible for technical reasons (morbid obesity, thoracic extensive subcutaneous emphysema, absorbent subcutaneous infiltrations, ...)
  • Patients with comorbidities justifying priority intensive care, not linked to the COVID-19 condition

Trial locations and contacts

1 site in 1 country.

France1 site
  • Urgences - Hôpital Cochin APHP

    Paris, 75014

Other trials in France

About this study

The recent pandemic due to the SARS-CoV2 results in a pulmonary infection in major symptomatic patients. Because of the large number of patients and the risk of acute respiratory distress syndrome (which seems to occur in almost 5% of patients), there is a real challenge to improve physician ability to screen between patients those who will require specific surveillance and those who can be sent back home. The recent French official recommendation of the French radiology society prescribe that chest X-ray do not have any place in the COVID-19+ management whereas the WHO stipulate that ultrasound machines may be useful for these patients [1-2]. Moreover, scattered recent publications tend to stress the interest of quick ultrasound imaging for COVID-19 suspected patients for screening purpose [2-5].

The aim of this observational historico-prospective study is to assess the risk of severe clinical outcomes (admission in continuous care unit (USC), invasive respiratory assistance, death) in patients suspected or diagnosed COVID-19+ as a function of initial pulmonary ultrasound abnormalities. These clinical outcomes are assessed through phone calls at D5, D15, M1.

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The secondary objectives are:

  • Assessing the concordance between the severity of pulmonary lesions as detected by pulmonary ultrasound devices and the ones detected by CT-scanner, for patients who will undergo these two examinations.
  • Assessing the compared performances in detecting ultrasound pulmonary lesions for patients suspected or diagnosed COVID-19+, between an experimented operator and a newly trained operator.
  • Evaluate in suspected or COVID-19 patients, the risk of clinical worsening based on pulmonary ultrasound abnormalities during follow-up of hospitalized patients.
  • Evaluate the ultrasound evolution profiles of pulmonary lesions in patients whose clinical evolution is favorable.
  • Evaluate the incidence of thromboembolic events in patients who worsen secondarily.
Read the detailed description

The practitioners involved at each site are

  • either emergency physicians who are experts in pulmonary ultrasound
  • either newly trained doctors who have received 30 minutes quick training in the fundamentals of pulmonary ultrasound.

The data collected under this protocol consists in:

  • data from clinical examination: blood pressure, heart rate, respiratory rate, saturation, signs of confusion, body temperature, calculation of the CRB65 and qSOFA score, date of onset of symptoms
  • Former patient journey: home, hospital, nursing home, others
  • Medical background
  • Recent use in the context of NSAID symptomatology
  • Long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) in the context of a known pathology
  • Results and date of PCR-Covid-19 test
  • Pulmonary ultrasound results: quotation in 8 fields (right antero-superior, left antero-superior, right antero-inferior, left antero-inferior, right postero-superior, left postero-superior, right postero-inferior and postero-upper left).
  • The operator's identity and level of expertise will be indicated.

Patients follow-up happens at D5, D15 and D28 through phone call. After verifying their identity using the initials entered and their date of birth, the patient or the referring person in the medical file is asked where the patient is currently (home, non ICU department, ICU department) and whether the patient is in respiratory assistance (invasive or not). In the event of notification of death, the date of occurrence will be indicated.

Patients are informed orally (in the event of altered state of consciousness, their close relative present will benefit from this information) that they will be contacted remotely (at D5, D15 and D28) to inquire about their development.

Patients hospitalized in most of the hospitals participating in the research will be offered a daily assessment of their clinical status, an ultrasound within 24-48 hours of the start of hospitalization, two other ultrasounds performed between D5 and D10. A final ultrasound will be performed before leaving the service.

In the event of worsening, a compression ultrasound of the lower limbs and a simple cardiac ultrasound is performed in search of signs of DVT or an acute pulmonary heart on a 4-point compression ultrasound and echocardiography which will be performed in the event of clinical worsening following the inclusion of the following :

  • Evidence of a thrombus proximal to 4-point echo compression due to non-compressibility and / or absence of color doppler flow during a venous flushing maneuver
  • Evidence of dilation of the ventricle Dt with VD / VG ratio> 1 or presence of a paradoxical septum.
  • A search for the occurrence of one of these 3 events
  • Addressing in intensive care units
  • Mechanical ventilation
  • Death. In the event of notification of death, the date of occurrence will be indicated.

The report of the examination will be given on a standardized examination sheet with identification of the patient on each examination + identifier of the clinician operator.

The data will be kept for remote reading by a referent. All these examinations are carried out as part of the management of patients for the treatment of their COVID infection.

Patients are also informed:

  • that any new information arising during the participation to the study, which could possibly modify his non opposition to this very participation, will be given
  • of the right to have communication of information, held by the investigators, concerning their health, during or at the end of the research.
  • Results of the chest scanner: typical COVID-19 and extent of the damage (minimal, moderate, severe)
  • Initial patient orientation: return home, simple hospitalization or continuous care unit (USC), with or without respiratory assistance (and of what type: invasive or non-invasive), death (date of death)
  • Whether or not to take chloroquine (on D0, D5, D15 or D28)
  • Patient follow-up: same data as during the initial orientation on day 0, day 5, day 15 and D28.
Being tested
Pulmonary ultrasound
Keywords
Pulmonary ultrasound, Diagnosis improvement, Screening, 2019-nCoV (COVID-19), Chest CT
Medical subject headings
COVID-19, Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulmonary ultrasoundOther

    Pulmonary ultrasound results: quotation in 8 fields (right antero-superior, left antero-superior, right antero-inferior, left antero-inferior, right postero-superior, left postero-superior, right postero-inferior and postero-upper left).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Association of pulmonary lesions on ultrasound on D0 classified according to three stages of severity

    Association of pulmonary lesions on ultrasound on D0 classified according to three stages of severity

    • There are few B lines at the lung bases
    • Bi-lateralization of B lines, numerous diffuse and / or curtain sign
    • Presence of signs of pulmonary consolidation, hepatization of the lung and air bronchogram)

    Measured: at day 0

Secondary outcomes (11)
  1. Assessment of the agreement between a newly trained operator and an experienced operator of classification in one of the three stages of ultrasound gravity, by Cohen's kappa coefficient.

    The operator's identity and level of expertise will be indicated:

    • emergency physicians who are experts in pulmonary ultrasound
    • newly trained doctors who have received 30 minutes quick training in the fundamentals of pulmonary ultrasound.

    Pulmonary ultrasound results:

    quotation in 8 fields (right antero-superior, left antero-superior, right antero-inferior, left antero-inferior, right postero-superior, left postero-superior, right postero-inferior and postero-upper left).

    Measured: at day 0

  2. Estimate in patients who had a CT-scan on D0, the agreement in the evaluation of the severity of lung lesions via ultrasound vs. CT-scan, by Cohen's kappa coefficient

    Pulmonary ultrasound results: quotation in 8 fields (right antero-superior, left antero-superior, right antero-inferior, left antero-inferior, right postero-superior, left postero-superior, right postero-inferior and postero-upper left).

    Results of the chest scanner: typical COVID-19 and extent of the damage (minimal, moderate, severe)

    Measured: at day 0

  3. Measurement of the cumulative incidence of invasive mechanical ventilation

    A search for the occurrence of one of these 3 events

    • Addressing in intensive care units
    • Mechanical ventilation
    • Death. In the event of notification of death, the date of occurrence will be indicated.

    Measured: at day 5

  4. Measurement of survival

    Patients follow-up happens at D5 through phone call. After verifying their identity using the initials entered and their date of birth, the patient or the referring person in the medical file is asked where the patient is currently (home, non ICU department, ICU department) and whether the patient is in respiratory assistance (invasive or not). In the event of notification of death, the date of occurrence will be indicated.

    Measured: at day 5

  5. Measurement of the cumulative incidence of invasive mechanical ventilation

    A search for the occurrence of one of these 3 events

    • Addressing in intensive care units
    • Mechanical ventilation
    • Death. In the event of notification of death, the date of occurrence will be indicated.

    Measured: at day 15

  6. Measurement of survival

    Patients follow-up happens at D15 through phone call. After verifying their identity using the initials entered and their date of birth, the patient or the referring person in the medical file is asked where the patient is currently (home, non ICU department, ICU department) and whether the patient is in respiratory assistance (invasive or not). In the event of notification of death, the date of occurrence will be indicated.

    Measured: at day 15

  7. Measurement of the cumulative incidence of invasive mechanical ventilation

    A search for the occurrence of one of these 3 events

    • Addressing in intensive care units
    • Mechanical ventilation
    • Death. In the event of notification of death, the date of occurrence will be indicated.

    Measured: at day 28

  8. Measurement of survival

    Patients follow-up happens at D28 through phone call. After verifying their identity using the initials entered and their date of birth, the patient or the referring person in the medical file is asked where the patient is currently (home, non ICU department, ICU department) and whether the patient is in respiratory assistance (invasive or not). In the event of notification of death, the date of occurrence will be indicated.

    Measured: at day 28

  9. Association of the worsening of pulmonary lesions with the ultrasound

    The kinetics of evolution of the pulmonary lesions with the favorable clinical evolution follow theses events:

    • stopping oxygen therapy
    • discharge from hospital
    • Presence of signs of DVT or an acute pulmonary heart on 4-point compression ultrasound and echocardiography

    Measured: Within 48 hours of arrival in the service

  10. Association of the worsening of pulmonary lesions with the ultrasound

    The kinetics of evolution of the pulmonary lesions with the favorable clinical evolution follow theses events:

    • stopping oxygen therapy
    • discharge from hospital
    • Presence of signs of DVT or an acute pulmonary heart on 4-point compression ultrasound and echocardiography

    Measured: Between the 5th and 10 days of hospitalization

  11. Association of the worsening of pulmonary lesions with the ultrasound

    The kinetics of evolution of the pulmonary lesions with the favorable clinical evolution follow theses events:

    • stopping oxygen therapy
    • discharge from hospital
    • Presence of signs of DVT or an acute pulmonary heart on 4-point compression ultrasound and echocardiography

    Measured: just before discharge from hospital or in case of worsening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2020
  2. Study start2 Apr 2020
  3. Primary completion26 May 2020
  4. Study completion26 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
328 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04335019
Sponsor's protocol ID
APHP200390
Other IDs
2020-A00768-31
Acronym
eChoVid
Status last verified
Nov 2021
First submitted
2 Apr 2020
Last updated
1 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • The recommendations of the French Radiology Society in the context of COVID-19 [Internet]. [cited 2020 Apr 1]. Available from: http://www.thema-radiologie.fr/actualites/2618/les-recommandations-de-la-societe-francaise-de-radiologie-dans-un-contexte-de-covid-19.html

  • WHO | Disease Commodity Packages [Internet]. [cited 2020 Apr 1]. Available from: https://www.who.int/emergencies/what-we-do/prevention-readiness/disease-commodity-packages/en/

  • Peng QY, Wang XT, Zhang LN; Chinese Critical Care Ultrasound Study Group (CCUSG). Findings of lung ultrasonography of novel corona virus pneumonia during the 2019-2020 epidemic. Intensive Care Med. 2020 May;46(5):849-850. doi: 10.1007/s00134-020-05996-6. Epub 2020 Mar 12. No abstract available.

    PubMed 32166346
  • Poggiali E, Dacrema A, Bastoni D, Tinelli V, Demichele E, Mateo Ramos P, Marciano T, Silva M, Vercelli A, Magnacavallo A. Can Lung US Help Critical Care Clinicians in the Early Diagnosis of Novel Coronavirus (COVID-19) Pneumonia? Radiology. 2020 Jun;295(3):E6. doi: 10.1148/radiol.2020200847. Epub 2020 Mar 13. No abstract available.

    PubMed 32167853
  • Buonsenso D, Pata D, Chiaretti A. COVID-19 outbreak: less stethoscope, more ultrasound. Lancet Respir Med. 2020 May;8(5):e27. doi: 10.1016/S2213-2600(20)30120-X. Epub 2020 Mar 20. No abstract available.

    PubMed 32203708

Questions about this trial

What is this clinical trial studying?

An observational study of 2019-nCoV (COVID-19) and Interstitial Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Association of pulmonary lesions on ultrasound on D0 classified according to three stages of severity (time frame: at day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04335019, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.

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