Follow-up of Respiratory Sequelae of Hospitalized Patients With COVID-19

NCT04505631 | Completed

• 2 other identifiers: GHRMSA 1052IDRCB 2020-A01089-30
• Study Type: observational
• Target: 332
• Locations: 1 country
• Sites: 14

Brief Summary

The objective of this multicenter observational study is to describe respiratory sequelae of COVID-19 patients hospitalized for severe pneumonia requiring oxygen supply.

Conditions

Covid19; Dyspnea

Keywords

COVID19; PNEUMOPATHY; DYSPNEA

Outcome Measures

Primary Outcomes (1)

• Presence of respiratory sequelae

  The presence of respiratory sequelae will be assessed by low dose thoracic tomodensitometry

  6 months after hospital discharge

Secondary Outcomes (31)

• Presence of respiratory sequelae on low dose thoracic tomodensitometry

  3 months after hospital discharge

• Forced vital capacity (FVC, %)

  6 months after hospital discharge

• Forced vital capacity (FVC, %)

  3 months after hospital discharge

• Forced expiratory volume in 1 second (FEV1, %)

  6 months after hospital discharge

• Forced expiratory volume in 1 second (FEV1, %)

  3 months after hospital discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been hospitalized for severe pneumonia due to SARS-CoV-2 infection will be seen in consultation at approximately 3 and 6 months after hospital discharge, as per standard practice.

You may qualify if:

• Age ≥ 18 years old
• SARS-CoV-2 infection proven by RT-PCR and/or retrospective serology and/or a COVID-19 syndrome with evocative chest CT scan
• Hospitalized for severe pneumonia due to SARS-CoV-2 infection requiring oxygen supply

You may not qualify if:

• Not hospitalized for a severe COVID-19 infection
• Absence of respiratory symptoms at V1 (3 months after hospital discharge), defined as: absence of residual exertional dyspnea and persistent pulmonary infiltrates on follow-up chest radiography at 1 month (if available), transcutaneous oxyhemoglobin saturation \>94% and normal pulmonary auscultation
• Patient with pre-existing chronic lung disease prior to the first episode of COVID-19: chronic obstructive pulmonary disease confirmed by respiratory function testing with a forced expiratory volume in one second (FEV1) \< 50% and/or a diffusing capacity for carbon monoxide (DLCO) \< 60%, fibrotic lung disease or chronic respiratory failure (on long-term oxygen therapy)
• Opposition to participation in the study
• Patient under legal protection
• Patient not affiliated to/beneficiary of a social security scheme

Sponsors & Collaborators

• Groupe Hospitalier de la Region de Mulhouse et Sud Alsace: lead

Study Sites (14)

Groupe Hospitalier de Mulhouse et de la Région Sud-Alsace

Mulhouse, Alsace, 68100, France

Location

Centre Hospitalier de la Côte Basque - Bayonne

Bayonne, France

Location

Centre Hospitalier Métropole Savoie

Chambéry, France

Location

Centre Hospitalier Colmar

Colmar, France

Location

Centre Hospitalier Douai

Douai, France

Location

Centre Hospitalier de Dunkerque

Dunkirk, France

Location

Centre Hospitalier Départemental Vendée - La Roche sur Yon

La Roche-sur-Yon, France

Location

Centre Hospitalier du Mans

Le Mans, France

Location

Centre Hospitalier Robert Boulin - Libourne

Libourne, France

Location

Centre Hospitalier Régional Metz-Thioville

Metz, France

Location

Centre Hospitalier Annecy Genevois

Metz-Tessy, France

Location

Centre Hospitalier Le Raincy Montfermeil

Montfermeil, France

Location

Centre Hospitalier Régional Orléans

Orléans, France

Location

Centre Hospitalier de Soissons

Soissons, France

Location

Related Publications (1)

• Calcaianu G, Degoul S, Michau B, Payen T, Gschwend A, Fore M, Iamandi C, Morel H, Oster JP, Bizieux A, Nocent-Ejnaini C, Carvallo C, Romanet S, Goupil F, Leurs A, Legrand MG, Portel L, Claustre J, Calcaianu M, Bresson D, Debieuvre D. Mid-term pulmonary sequelae after hospitalisation for COVID-19: The French SISCOVID cohort. Respir Med Res. 2022 Nov;82:100933. doi: 10.1016/j.resmer.2022.100933. Epub 2022 Jun 14.

  PMID: 35905553 RESULT

MeSH Terms

Conditions

COVID-19; Dyspnea; Lung Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• George-Daniel Calcaianu, MD

  GHRMSA hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 10, 2020
• Study Start: June 10, 2020
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (14)