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.
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.
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.
Read more
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.
- Conditions
- 2019-nCoV (COVID-19), Interstitial Pneumonia
- 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.
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)
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
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
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
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
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
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
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
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
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
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
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.
- First posted6 Apr 2020
- Study start2 Apr 2020
- Primary completion26 May 2020
- Study completion26 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 2019-nCoV (COVID-19)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehdi BENCHOUFI, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
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 32166346Poggiali 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 32167853Buonsenso 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Use of Pulmonary Ultrasound in the Referral of Patients With or Suspected COVID-19 +
- ClinicalTrials.gov ID
- NCT04335019
- Acronym / sponsor ID
- eChoVid / APHP200390
- Conditions
- 2019-nCoV (COVID-19), Interstitial Pneumonia
- Keywords
- Pulmonary ultrasound, Diagnosis improvement, Screening, 2019-nCoV (COVID-19), Chest CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 26 May 2020 (actual)
- Study completion
- 26 May 2020 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Suspected of COVID-19 infection or having a systematic COVID-19 screening
Key inclusion criteria (2 listed)
- > 18 years old
- Suspected of COVID-19 infection or having a systematic COVID-19 screening
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary ultrasoundPulmonary 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). | Other | – |
Primary outcome
Association of pulmonary lesions on ultrasound on D0 classified according to three stages of severity
Time frame: at day 0
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)
11 secondary outcomes
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.
Time frame: at day 0
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
Time frame: at day 0
Measurement of the cumulative incidence of invasive mechanical ventilation
Time frame: at day 5
Measurement of survival
Time frame: at day 5
Measurement of the cumulative incidence of invasive mechanical ventilation
Time frame: at day 15
Measurement of survival
Time frame: at day 15
Measurement of the cumulative incidence of invasive mechanical ventilation
Time frame: at day 28
Measurement of survival
Time frame: at day 28
Association of the worsening of pulmonary lesions with the ultrasound
Time frame: Within 48 hours of arrival in the service
Association of the worsening of pulmonary lesions with the ultrasound
Time frame: Between the 5th and 10 days of hospitalization
Association of the worsening of pulmonary lesions with the ultrasound
Time frame: just before discharge from hospital or in case of worsening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- BackgroundThe 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
- BackgroundWHO | Disease Commodity Packages [Internet]. [cited 2020 Apr 1]. Available from: https://www.who.int/emergencies/what-we-do/prevention-readiness/disease-commodity-packages/en/
- Background: PubMed 32166346Peng 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.
- Background: PubMed 32167853Poggiali 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.
- Background: PubMed 32203708Buonsenso 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehdi BENCHOUFI, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
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.