Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04505631
Recruitment Status : Recruiting
First Posted : August 10, 2020
Last Update Posted : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

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.

Condition or disease
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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Follow-up of Respiratory Sequelae of Patients Hospitalized With SARS-CoV-2: a Prospective Multicenter Observational Study
Actual Study Start Date : June 10, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04505631


Contacts
Layout table for location contacts
Contact: Marie Diesel +33 3 89 64 84 28 marie.diesel@ghrmsa.fr

Locations
Layout table for location information
France
Groupe Hospitalier de Mulhouse et de la Région Sud-Alsace Recruiting
Mulhouse, Alsace, France, 68100
Contact: George-Daniel Calcaianu, MD    + 33 3 89 64 70 28    george-daniel.calcaianu@ghrmsa.fr   
Sub-Investigator: Didier Debieuvre, MD         
Centre Hospitalier de la Côte Basque - Bayonne Recruiting
Bayonne, France
Contact: Cécilia Nocent-Ejnaini, MD         
Centre Hospitalier Métropole Savoie Recruiting
Chambéry, France
Contact: Johanna Claustre, MD         
Centre Hospitalier Colmar Recruiting
Colmar, France
Contact: Jean-Philippe Oster, MD         
Centre Hospitalier Douai Recruiting
Douai, France
Contact: Stéphanie Romanet, MD         
Centre Hospitalier de Dunkerque Recruiting
Dunkerque, France
Contact: Amélie Leurs, MD         
Centre Hospitalier Départemental Vendée - La Roche sur Yon Recruiting
La Roche-sur-Yon, France
Contact: Acya Bizieux, MD         
Centre Hospitalier du Mans Recruiting
Le Mans, France
Contact: François Goupil, MD         
Centre Hospitalier Robert Boulin - Libourne Recruiting
Libourne, France
Contact: Laurent Portel, MD         
Centre Hospitalier Annecy Genevois Recruiting
Metz-Tessy, France
Contact: Stéphane Hominal, MD         
Centre Hospitalier Régional Metz-Thioville Recruiting
Metz, France
Contact: Nadine Paillot, MD         
Centre Hospitalier Le Raincy Montfermeil Recruiting
Montfermeil, France
Contact: Cécile Carvallo, MD         
Centre Hospitalier Régional Orléans Recruiting
Orléans, France
Contact: Hugues Morel, MD         
Centre Hospitalier de Soissons Recruiting
Soissons, France
Contact: Marie-Germaine Legrand, MD         
Sponsors and Collaborators
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Investigators
Layout table for investigator information
Principal Investigator: George-Daniel Calcaianu, MD GHRMSA hospital
Layout table for additonal information
Responsible Party: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
ClinicalTrials.gov Identifier: NCT04505631    
Other Study ID Numbers: GHR 1052
IDRCB 2020-A01089-30 ( Other Identifier: ANSM )
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace:
COVID19
PNEUMOPATHY
DYSPNEA
Additional relevant MeSH terms:
Layout table for MeSH terms
Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory