Skip to main content
OpenTrials
Completed

NCT Number: NCT04505631

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier de Mulhouse et de la Région Sud-Alsace, Mulhouse, Alsace, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Presence of respiratory sequelae

    Time frame: 6 months after hospital discharge

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

Secondary outcomes

  1. Presence of respiratory sequelae on low dose thoracic tomodensitometry

    Time frame: 3 months after hospital discharge

  2. Forced vital capacity (FVC, %)

    Time frame: 6 months after hospital discharge

    Respiratory functional exploration

  3. Forced vital capacity (FVC, %)

    Time frame: 3 months after hospital discharge

    Respiratory functional exploration

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

    Time frame: 6 months after hospital discharge

    Respiratory functional exploration

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

    Time frame: 3 months after hospital discharge

    Respiratory functional exploration

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

    Time frame: 6 months after hospital discharge

    Respiratory functional exploration

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

    Time frame: 3 months after hospital discharge

    Respiratory functional exploration

  8. Total lung capacity (TLC, %)

    Time frame: 6 months after hospital discharge

    Respiratory functional exploration

  9. Total lung capacity (TLC, %)

    Time frame: 3 months after hospital discharge

    Respiratory functional exploration

  10. Residual volume (RV, %)

    Time frame: 6 months after hospital discharge

    Respiratory functional exploration

  11. Residual volume (RV, %)

    Time frame: 3 months after hospital discharge

    Respiratory functional exploration

  12. RV/TLC ratio (%)

    Time frame: 6 months after hospital discharge

    Respiratory functional exploration

  13. RV/TLC ratio (%)

    Time frame: 3 months after hospital discharge

    Respiratory functional exploration

  14. Maximal inspiratory pressure (MIP, %)

    Time frame: 6 months after hospital discharge

    Respiratory functional exploration

  15. Maximal inspiratory pressure (MIP, %)

    Time frame: 3 months after hospital discharge

    Respiratory functional exploration

  16. Maximal expiratory pressure (MEP, %)

    Time frame: 6 months after hospital discharge

    Respiratory functional exploration

  17. Maximal expiratory pressure (MEP, %)

    Time frame: 3 months after hospital discharge

    Respiratory functional exploration

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

    Time frame: 6 months after hospital discharge

    Respiratory functional exploration

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

    Time frame: 3 months after hospital discharge

    Respiratory functional exploration

  20. pH

    Time frame: 6 months after hospital discharge

    Arterial gasometry will be performed under ambient air and under oxygen

  21. pH

    Time frame: 3 months after hospital discharge

    Arterial gasometry will be performed under ambient air and under oxygen

  22. Arterial oxygen partial pressure (PaO2, mmHg)

    Time frame: 6 months after hospital discharge

    Arterial gasometry will be performed under ambient air and under oxygen

  23. Arterial oxygen partial pressure (PaO2, mmHg)

    Time frame: 3 months after hospital discharge

    Arterial gasometry will be performed under ambient air and under oxygen

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

    Time frame: 6 months after hospital discharge

    Arterial gasometry will be performed under ambient air and under oxygen

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

    Time frame: 3 months after hospital discharge

    Arterial gasometry will be performed under ambient air and under oxygen

  26. Bicarbonate concentration (mmol/L)

    Time frame: 6 months after hospital discharge

    Arterial gasometry will be performed under ambient air and under oxygen

  27. Bicarbonate concentration (mmol/L)

    Time frame: 3 months after hospital discharge

    Arterial gasometry will be performed under ambient air and under oxygen

  28. Arterial oxygen saturation (SaO2, %)

    Time frame: 6 months after hospital discharge

    Arterial gasometry will be performed under ambient air and under oxygen

  29. Arterial oxygen saturation (SaO2, %)

    Time frame: 3 months after hospital discharge

    Arterial gasometry will be performed under ambient air and under oxygen

  30. Six-minute walk test

    Time frame: 6 months after hospital discharge

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

  31. Six-minute walk test

    Time frame: 3 months after hospital discharge

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

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Other

Registry information

Official study title

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

Acronym: SISCOVID

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 10, 2020
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.