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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05226403
Other study ID # 2020-A01225-34
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date December 31, 2021

Study information

Verified date February 2022
Source Geprovas
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. 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. 2. And presenting, at the time of inclusion between the 5th and 10th day of infection, one of the respiratory signs of severity felt: - Dyspnea, shortness of breath or difficulty in breathing - Chest pain or tightness Exclusion Criteria: 1. 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 2. The presence of acute respiratory signs clearly having a cause other than a COVID-19 infection.

Study Design


Locations

Country Name City State
France GEPROVAS Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
Geprovas

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Clinical Signs Clinical signs positives in the cas of presence one of these elements: Hypoxia, Tachypnée, Pathological pulmonary auscultation. Day 5 and Day 10
Secondary Ultrasound signs Ultrasound signs positives in the case of presence one of these elements: Disappearance of lines A, Appearance of three lines B, Appearance of pulmonary condensation. Between day 5 and day 10
Secondary Evolution and complication Number of deaths and patients admitted to hospital for worsening of respiratory signs of infection Day 14 of infection
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