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

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Oct 2021

Status
unknown

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

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
3 days until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

October 12, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

September 30, 2021

Last Update Submit

October 8, 2021

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

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

Central Study Contacts

VINCENT François, Pr

CONTACT

05 55 05 61 45francois.vincent@chu-limoges.fr

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

October 15, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

October 12, 2021

Record last verified: 2021-09