Follow-up of Respiratory Sequelae of Hospitalized Patients With COVID-19 (SISCOVID)

Follow-up of Respiratory Sequelae of Patients Hospitalized With SARS-CoV-2: a Prospective Multicenter Observational Study

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

Study Overview

• Status: Completed
• Conditions: Covid19; Dyspnea

Detailed Description

Main objective To assess respiratory sequelae after SARS-CoV-2 infection in hospitalized patients with severe pneumonia requiring oxygen supply and followed up for 6 months after hospital discharge (see primary and secondary outcomes).

Secondary objectives

To describe pulmonary sequelae according to :

• the unit in which the patient was hospitalized,
• the maximum oxygen flow rate required during hospitalization,
• McCabe score,
• age,
• tobacco consumption,
• biological data (e.g. blood count, CRP, fibrinogen, LDH, albumin, D-dimer, ferritin),
• number of days from onset of symptoms to hospitalization,
• co-morbidities (e.g. diabetes, hypertension, coronary artery disease/heart failure, mild to moderate COPD/respiratory failure, overweight),
• concomitant treatments (e.g. non-steroidal anti-inflammatory drugs, corticosteroids, immunosuppressants, ACE inhibitors)
• specific drug treatments administered to treat COVID-19 infection,
• non-drug treatments (invasive ventilation, non-invasive ventilation, postural treatment) to manage respiratory disorders of COVID-19 infection.

To assess the impact of factors of social inequality on the severity of COVID-19 infection.

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

• Study Type: Observational
• Enrollment (Actual): 332

Contacts and Locations

Study Locations

• France
  • Bayonne, France
    • Centre Hospitalier de la Côte Basque - Bayonne
  • Chambéry, France
    • Centre Hospitalier Metropole Savoie
  • Colmar, France
    • Centre Hospitalier Colmar
  • Douai, France
    • Centre Hospitalier Douai
  • Dunkerque, France
    • Centre Hospitalier de Dunkerque
  • La Roche-sur-Yon, France
    • Centre Hospitalier Départemental Vendée - La Roche sur Yon
  • Le Mans, France
    • Centre Hospitalier du Mans
  • Libourne, France
    • Centre Hospitalier Robert Boulin - Libourne
  • Metz, France
    • Centre Hospitalier Régional Metz-Thioville
  • Metz-Tessy, France
    • Centre Hospitalier Annecy Genevois
  • Montfermeil, France
    • Centre Hospitalier Le Raincy Montfermeil
  • Orléans, France
    • Centre Hospitalier Régional Orléans
  • Soissons, France
    • Centre Hospitalier de Soissons
  • Alsace
    • Mulhouse, Alsace, France, 68100
      • Groupe Hospitalier de Mulhouse et de la Région Sud-Alsace

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion criteria:

• 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

Exclusion criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of respiratory sequelae	The presence of respiratory sequelae will be assessed by low dose thoracic tomodensitometry	6 months after hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of respiratory sequelae on low dose thoracic tomodensitometry		3 months after hospital discharge
Forced vital capacity (FVC, %)	Respiratory functional exploration	6 months after hospital discharge
Forced vital capacity (FVC, %)	Respiratory functional exploration	3 months after hospital discharge
Forced expiratory volume in 1 second (FEV1, %)	Respiratory functional exploration	6 months after hospital discharge
Forced expiratory volume in 1 second (FEV1, %)	Respiratory functional exploration	3 months after hospital discharge
Tiffeneau-Pinelli index (FEV1/FVC, %)	Respiratory functional exploration	6 months after hospital discharge
Tiffeneau-Pinelli index (FEV1/FVC, %)	Respiratory functional exploration	3 months after hospital discharge
Total lung capacity (TLC, %)	Respiratory functional exploration	6 months after hospital discharge
Total lung capacity (TLC, %)	Respiratory functional exploration	3 months after hospital discharge
Residual volume (RV, %)	Respiratory functional exploration	6 months after hospital discharge
Residual volume (RV, %)	Respiratory functional exploration	3 months after hospital discharge
RV/TLC ratio (%)	Respiratory functional exploration	6 months after hospital discharge
RV/TLC ratio (%)	Respiratory functional exploration	3 months after hospital discharge
Maximal inspiratory pressure (MIP, %)	Respiratory functional exploration	6 months after hospital discharge
Maximal inspiratory pressure (MIP, %)	Respiratory functional exploration	3 months after hospital discharge
Maximal expiratory pressure (MEP, %)	Respiratory functional exploration	6 months after hospital discharge
Maximal expiratory pressure (MEP, %)	Respiratory functional exploration	3 months after hospital discharge
Diffusion capacity of the lungs for carbon monoxide (DLCO, %)	Respiratory functional exploration	6 months after hospital discharge
Diffusion capacity of the lungs for carbon monoxide (DLCO, %)	Respiratory functional exploration	3 months after hospital discharge
pH	Arterial gasometry will be performed under ambient air and under oxygen	6 months after hospital discharge
pH	Arterial gasometry will be performed under ambient air and under oxygen	3 months after hospital discharge
Arterial oxygen partial pressure (PaO2, mmHg)	Arterial gasometry will be performed under ambient air and under oxygen	6 months after hospital discharge
Arterial oxygen partial pressure (PaO2, mmHg)	Arterial gasometry will be performed under ambient air and under oxygen	3 months after hospital discharge
Arterial carbon dioxide partial pressure (PaCO2, mmHg)	Arterial gasometry will be performed under ambient air and under oxygen	6 months after hospital discharge
Arterial carbon dioxide partial pressure (PaCO2, mmHg)	Arterial gasometry will be performed under ambient air and under oxygen	3 months after hospital discharge
Bicarbonate concentration (mmol/L)	Arterial gasometry will be performed under ambient air and under oxygen	6 months after hospital discharge
Bicarbonate concentration (mmol/L)	Arterial gasometry will be performed under ambient air and under oxygen	3 months after hospital discharge
Arterial oxygen saturation (SaO2, %)	Arterial gasometry will be performed under ambient air and under oxygen	6 months after hospital discharge
Arterial oxygen saturation (SaO2, %)	Arterial gasometry will be performed under ambient air and under oxygen	3 months after hospital discharge
Six-minute walk test	Six-minute walk test will be performed under ambient air and under oxygen	6 months after hospital discharge
Six-minute walk test	Six-minute walk test will be performed under ambient air and under oxygen	3 months after hospital discharge

Collaborators and Investigators

• Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
• Investigators: Principal Investigator: George-Daniel Calcaianu, MD, GHRMSA hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2020
• Primary Completion (Actual): January 15, 2021
• Study Completion (Actual): January 15, 2021

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: COVID19; PNEUMOPATHY; DYSPNEA
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Signs and Symptoms, Respiratory; COVID-19; Dyspnea
• Other Study ID Numbers: GHR 1052; IDRCB 2020-A01089-30 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No