AzTrials
AzTrials

Covid19SISCOVIDNCT04505631

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

An observational study of Covid19 and Dyspnea, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 14 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19, Dyspnea
How many people
332 participants
Where
14 sitesFrance
Study dates
10 Jun 2020to 15 Jan 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

France14 sites

  • Centre Hospitalier de la Côte Basque - Bayonne

    Bayonne

  • Centre Hospitalier Métropole Savoie

    Chambéry

  • Centre Hospitalier Colmar

    Colmar

  • Centre Hospitalier Douai

    Douai

  • Centre Hospitalier de Dunkerque

    Dunkirk

  • Centre Hospitalier Départemental Vendée - La Roche sur Yon

    La Roche-sur-Yon

  • Centre Hospitalier du Mans

    Le Mans

  • Centre Hospitalier Robert Boulin - Libourne

    Libourne

  • Centre Hospitalier Régional Metz-Thioville

    Metz

  • Centre Hospitalier Annecy Genevois

    Metz-Tessy

  • Centre Hospitalier Le Raincy Montfermeil

    Montfermeil

  • Groupe Hospitalier de Mulhouse et de la Région Sud-Alsace

    Mulhouse, Alsace, 68100

  • Centre Hospitalier Régional Orléans

    Orléans

  • Centre Hospitalier de Soissons

    Soissons

Other trials in France

About this study

Official title: 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.

Read the 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.

Conditions
Covid19, Dyspnea
Keywords
COVID19, PNEUMOPATHY, DYSPNEA
Medical subject headings
COVID-19, Dyspnea, Lung Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of respiratory sequelae

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

    Measured: 6 months after hospital discharge

Secondary outcomes (31)

  1. Presence of respiratory sequelae on low dose thoracic tomodensitometry

    Measured: 3 months after hospital discharge

  2. Forced vital capacity (FVC, %)

    Respiratory functional exploration

    Measured: 6 months after hospital discharge

  3. Forced vital capacity (FVC, %)

    Respiratory functional exploration

    Measured: 3 months after hospital discharge

  4. Forced expiratory volume in 1 second (FEV1, %)

    Respiratory functional exploration

    Measured: 6 months after hospital discharge

  5. Forced expiratory volume in 1 second (FEV1, %)

    Respiratory functional exploration

    Measured: 3 months after hospital discharge

  6. Tiffeneau-Pinelli index (FEV1/FVC, %)

    Respiratory functional exploration

    Measured: 6 months after hospital discharge

  7. Tiffeneau-Pinelli index (FEV1/FVC, %)

    Respiratory functional exploration

    Measured: 3 months after hospital discharge

  8. Total lung capacity (TLC, %)

    Respiratory functional exploration

    Measured: 6 months after hospital discharge

  9. Total lung capacity (TLC, %)

    Respiratory functional exploration

    Measured: 3 months after hospital discharge

  10. Residual volume (RV, %)

    Respiratory functional exploration

    Measured: 6 months after hospital discharge

  11. Residual volume (RV, %)

    Respiratory functional exploration

    Measured: 3 months after hospital discharge

  12. RV/TLC ratio (%)

    Respiratory functional exploration

    Measured: 6 months after hospital discharge

  13. RV/TLC ratio (%)

    Respiratory functional exploration

    Measured: 3 months after hospital discharge

  14. Maximal inspiratory pressure (MIP, %)

    Respiratory functional exploration

    Measured: 6 months after hospital discharge

  15. Maximal inspiratory pressure (MIP, %)

    Respiratory functional exploration

    Measured: 3 months after hospital discharge

  16. Maximal expiratory pressure (MEP, %)

    Respiratory functional exploration

    Measured: 6 months after hospital discharge

  17. Maximal expiratory pressure (MEP, %)

    Respiratory functional exploration

    Measured: 3 months after hospital discharge

  18. Diffusion capacity of the lungs for carbon monoxide (DLCO, %)

    Respiratory functional exploration

    Measured: 6 months after hospital discharge

  19. Diffusion capacity of the lungs for carbon monoxide (DLCO, %)

    Respiratory functional exploration

    Measured: 3 months after hospital discharge

  20. pH

    Arterial gasometry will be performed under ambient air and under oxygen

    Measured: 6 months after hospital discharge

  21. pH

    Arterial gasometry will be performed under ambient air and under oxygen

    Measured: 3 months after hospital discharge

  22. Arterial oxygen partial pressure (PaO2, mmHg)

    Arterial gasometry will be performed under ambient air and under oxygen

    Measured: 6 months after hospital discharge

  23. Arterial oxygen partial pressure (PaO2, mmHg)

    Arterial gasometry will be performed under ambient air and under oxygen

    Measured: 3 months after hospital discharge

  24. Arterial carbon dioxide partial pressure (PaCO2, mmHg)

    Arterial gasometry will be performed under ambient air and under oxygen

    Measured: 6 months after hospital discharge

  25. Arterial carbon dioxide partial pressure (PaCO2, mmHg)

    Arterial gasometry will be performed under ambient air and under oxygen

    Measured: 3 months after hospital discharge

  26. Bicarbonate concentration (mmol/L)

    Arterial gasometry will be performed under ambient air and under oxygen

    Measured: 6 months after hospital discharge

  27. Bicarbonate concentration (mmol/L)

    Arterial gasometry will be performed under ambient air and under oxygen

    Measured: 3 months after hospital discharge

  28. Arterial oxygen saturation (SaO2, %)

    Arterial gasometry will be performed under ambient air and under oxygen

    Measured: 6 months after hospital discharge

  29. Arterial oxygen saturation (SaO2, %)

    Arterial gasometry will be performed under ambient air and under oxygen

    Measured: 3 months after hospital discharge

  30. Six-minute walk test

    Six-minute walk test will be performed under ambient air and under oxygen

    Measured: 6 months after hospital discharge

  31. Six-minute walk test

    Six-minute walk test will be performed under ambient air and under oxygen

    Measured: 3 months after hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2020
  2. Study start10 Jun 2020
  3. Primary completion15 Jan 2021
  4. Study completion15 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
332 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04505631
Sponsor's protocol ID
GHRMSA 1052
Other IDs
IDRCB 2020-A01089-30
Acronym
SISCOVID
Status last verified
Nov 2025
First submitted
3 Aug 2020
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35905553

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and Dyspnea, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of respiratory sequelae (time frame: 6 months after hospital discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04505631, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in