NCT05226403

Brief Summary

COVID-19 infection are characterized by fever and signs of acute respiratory infection. A worsening of respiratory symptoms that can lead to respiratory failure. The decompensation can then be brutal and require rapid recourse to respiratory assistance. The contribution of clinical examination (auscultation and monitoring of oxygen saturation in particular) remains unsatisfactory in predicting an unfavorable course. The interest of pulmonary ultrasound is known in the management of pulmonary infections. However, estimating the severity of lung damage at an early stage could be of great help in monitoring and caring for patients. Ultrasound could meet this need in general practice, the chest scanner is often unavailable in these situations. Ultrasound signs are associated with severe forms. The contribution of pulmonary ultrasound seems particularly interesting in the context of the reassessment of patients during the worsening phase of symptoms (D5-D10). Estimate the prevalence of ultrasound signs in patients with an acute respiratory infection suspected or confirmed to be COVID-19, at the time of the worsening phase (between D5 and D10 of the onset of symptoms). The prevalence of ultrasound lung lesions under COVID-19 may be essential to consider the development of the ultrasound tool in primary care. Indeed, if the contribution of ultrasound is now recognized in intensive care or emergency, its place in general medicine still raises questions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
Last Updated

February 7, 2022

Status Verified

February 1, 2022

Enrollment Period

1.5 years

First QC Date

January 26, 2022

Last Update Submit

February 4, 2022

Conditions

Keywords

COVID19

Outcome Measures

Primary Outcomes (1)

  • Ultrasound Signs

    Frequency of the presence of at least one ultrasound sign in the subjects included

    Between day 5 and day 10 of infection

Secondary Outcomes (3)

  • Clinical Signs

    Day 5 and Day 10

  • Ultrasound signs

    Between day 5 and day 10

  • Evolution and complication

    Day 14 of infection

Eligibility Criteria

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

Adults with acute respiratory infection linked to COVID-19

You may qualify if:

  • Patients over 18 years of age with :
  • a clinical symptomatology suggesting an acute respiratory infection linked to COVID-19 defined by the following two categories of symptoms:
  • Sudden fever (or a feeling of fever)
  • Respiratory signs (cough, dyspnea, chest tightness) Or
  • an acute respiratory infection confirmed to COVID-19 by the result of RT-PCR screening tests.
  • Dyspnea, shortness of breath or difficulty in breathing
  • Chest pain or tightness

You may not qualify if:

  • The presence of a severe form during the initial consultation. A severe form is defined by the presence of the following signs:
  • Polypnea\> 22 / min
  • systolic BP \<90 mmHg
  • Sp02 \<90%
  • Altered consciousness, confusion, drowsiness
  • Dehydration
  • Alteration of the general condition in the elderly
  • The presence of acute respiratory signs clearly having a cause other than a COVID-19 infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GEPROVAS

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

COVID-19Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

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

Study Record Dates

First Submitted

January 26, 2022

First Posted

February 7, 2022

Study Start

July 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 7, 2022

Record last verified: 2022-02

Locations