NCT05074927

Brief Summary

The current state of knowledge shows the presence of respiratory sequelae after acute infection with COVID-19 and the importance of these long-term respiratory dysfunctions have to be determined. Aim of our study is describe diaphragmatic amplitude using diaphragm ultrasonography in patients recovering from SARS-CoV-2 pneumonia at 3 and 6 months after the acute episode.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

September 30, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

January 31, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2023

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2026

Completed
Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

1.4 years

First QC Date

September 30, 2021

Last Update Submit

June 25, 2026

Conditions

COVID-19

Keywords

Lung functionDiaphragm ultrasonographyChronic Inflammatory Rheumatism

Outcome Measures

Primary Outcomes (1)

  • The change diaphragmatic amplitude using diaphragm ultrasonography in patients recovering from SARS-CoV-2 pneumonia.

    Diaphragmatic amplitude assessed by ultrasound at M0 and M3.

    at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges

Secondary Outcomes (8)

  • the correlation between the values of diaphragmatic travel and Pi max and Pe max at M0 and M3.

    at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges

  • the difference in diaphragmatic amplitude between M0 and M3.

    at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges

  • the difference in FEV1 between M0 and M3.

    at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges

  • the difference in FVC between M0 and M3.

    at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges

  • the difference in DLCO between M0 and M3.

    at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges

  • +3 more secondary outcomes

Study Arms (1)

Cohort

OTHER

All patients with confirmed COVID-19 who had been discharged from CHRU Hospital in Limoges (France)

Diagnostic Test: diaphragm ultrasonography

Interventions

diaphragm ultrasonographyDIAGNOSTIC_TEST

For all patients with confirmed COVID-19 who had been discharged from CHRU Hospital in Limoges (France) : diaphragm ultrasonography at 3 (M0) and 6 months (M3) after the end of his hospitalisation

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • SARS-CoV-2 infection proven by RT-PCR.
  • Patient hospitalised for the management of SARS-CoV-2 infection and included 3 months after the end of his hospitalisation at the CHU of Limoges.
  • Patient of legal age.
  • Patient affiliated to a social security regime.
  • Patient having given informed consent

You may not qualify if:

  • Known pregnancy.
  • Patients who are contraindicated to perform the 6-minute walk test.
  • Patients unable to understand or adhere to the protocol.
  • Patients deprived of liberty.
  • Patients under court order, tutorship or curatorship.
  • Minor patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Dupuytren

Limoges, 87042, France

Location

chu Limoges

Limoges, 87042, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • VINCENT François, Pr

    CHU Limoges

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2021

First Posted

October 12, 2021

Study Start

January 31, 2022

Primary Completion

July 13, 2023

Study Completion

July 13, 2026

Last Updated

June 26, 2026

Record last verified: 2026-06

Locations

FR(2)