NCT04338100

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
307

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 8, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2020

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2020

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

March 31, 2020

Last Update Submit

March 7, 2022

Conditions

COVIDCoronavirus Infection

Keywords

COVID-19SARS-CoV-2POCUSLung ultrasonographyRisk-stratification

Outcome Measures

Primary Outcomes (1)

  • Risk of unfavourable outcome at D14

    To assess, in patients with confirmed or probable SARS-CoV-2 infection, chest ultrasonography capacity, using the POCUS score for ARDS, to identify patients with unfavourable outcome at D14. Unfavourable outcome is defined by intubation with mechanical ventilation requirement or death (Stage ≥ 6 on "Ordinal Scale for Clinical Improvement" of the World Health Organization) within 14 days of inclusion. We will determine the 95% confidence interval of the AUC of the ROC curve and consider POCUS capacity as clinically relevant if the lower limit of the 95% confidence interval is at least 0.7.

    14 days

Secondary Outcomes (7)

  • Risk of unfavourable outcome over time

    14 days

  • Risk-stratification threshold values

    14 days

  • Adding value of POCUS score to previous risk-stratification clinical rules

    14 days

  • POCUS score and patient clinical status at D14

    14 days

  • POCUS and CT scan correlation

    14 days

  • +2 more secondary outcomes

Study Arms (1)

Chest Ultrasound

Only one arm, all included patients having chest ultrasonography.

Procedure: Follow-up at 14 days

Interventions

Follow-up at 14 daysPROCEDURE

Point of care chest ultrasonography and 14-day follow-up to assess the evolution of the infection and care requirement (invasive ventilation or death)

Chest Ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults patients consulting emergency department with non-severe suspected or confirmed SARS-CoV-2 infection (COVID-19)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Florence DUPRIEZ

Brussels, BE 1200, Belgium

Location

MORIN François

Angers, 49933, France

Location

COUTURAUD Francis

Brest, 29200, France

Location

BAUDIN Laure

Cholet, 49325, France

Location

TAZAROURTE Karim

Lyon, 69002, France

Location

LE CONTE Philippe

Nantes, 44093, France

Location

MARJANOVIC Nicolas

Poitiers, 86000, France

Location

SOULAT Louis

Rennes, 35033, France

Location

JOLY Luc-Marie

Rouen, 76000, France

Location

DELOMAS Thomas

Saint-Lô, 50000, France

Location

FLAMENT Thomas

Tours, 37044, France

Location

Related Publications (5)

  • Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

    PMID: 32109013RESULT

  • Rodriguez-Morales AJ, Cardona-Ospina JA, Gutierrez-Ocampo E, Villamizar-Pena R, Holguin-Rivera Y, Escalera-Antezana JP, Alvarado-Arnez LE, Bonilla-Aldana DK, Franco-Paredes C, Henao-Martinez AF, Paniz-Mondolfi A, Lagos-Grisales GJ, Ramirez-Vallejo E, Suarez JA, Zambrano LI, Villamil-Gomez WE, Balbin-Ramon GJ, Rabaan AA, Harapan H, Dhama K, Nishiura H, Kataoka H, Ahmad T, Sah R; Latin American Network of Coronavirus Disease 2019-COVID-19 Research (LANCOVID-19). Electronic address: https://www.lancovid.org. Clinical, laboratory and imaging features of COVID-19: A systematic review and meta-analysis. Travel Med Infect Dis. 2020 Mar-Apr;34:101623. doi: 10.1016/j.tmaid.2020.101623. Epub 2020 Mar 13.

    PMID: 32179124RESULT

  • Lichtenstein DA, Meziere GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol. Chest. 2008 Jul;134(1):117-25. doi: 10.1378/chest.07-2800. Epub 2008 Apr 10.

    PMID: 18403664RESULT

  • Zhao Z, Jiang L, Xi X, Jiang Q, Zhu B, Wang M, Xing J, Zhang D. Prognostic value of extravascular lung water assessed with lung ultrasound score by chest sonography in patients with acute respiratory distress syndrome. BMC Pulm Med. 2015 Aug 23;15:98. doi: 10.1186/s12890-015-0091-2.

    PMID: 26298866RESULT

  • Morin F, Douillet D, Hamel JF, Rakotonjanahary J, Dupriez F, Savary D, Aube C, Riou J, Dubee V, Roy PM. Point-of-care ultrasonography for risk stratification of non-critical COVID-19 patients on admission (POCUSCO): a study protocol of an international study. BMJ Open. 2021 Feb 10;11(2):e041118. doi: 10.1136/bmjopen-2020-041118.

    PMID: 33568367DERIVED

Related Links

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Philippe LE CONTE, Pr

    University Hospital of Nantes

    PRINCIPAL INVESTIGATOR

  • Thomas FLAMENT, Dr

    University Hospital of Tours

    PRINCIPAL INVESTIGATOR

  • Louis SOULAT, Pr

    University Hospital of Rennes

    PRINCIPAL INVESTIGATOR

  • Nicolas MARJANOVIC, Dr

    University Hospital of Poitiers

    PRINCIPAL INVESTIGATOR

  • Francis COUTURAUD, Dr

    University Hospital of Brest

    PRINCIPAL INVESTIGATOR

  • Laure BAUDIN, Dr

    Hospital of Cholet

    PRINCIPAL INVESTIGATOR

  • Karim TAZAROURTE, Pr

    Hospices Civils de Lyon (University Hospital of Lyon)

    PRINCIPAL INVESTIGATOR

  • Thomas DELOMAS, Dr

    Hospital of Saint-Lô

    PRINCIPAL INVESTIGATOR

  • Luc-Marie JOLY, Pr

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 8, 2020

Study Start

April 8, 2020

Primary Completion

June 5, 2020

Study Completion

June 23, 2020

Last Updated

March 22, 2022

Record last verified: 2020-03

Locations

BE(1)FR(10)