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

Lung Damage Caused by SARS-CoV-2 Pneumonia (COVID-19) (SequelaeCov)

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: NCT04435327
Recruitment Status : Recruiting
First Posted : June 17, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
University of Milano Bicocca

Brief Summary:

Pneumonia is a recurrent element of COVID-19 infection, it is often associated with development of respiratory failure and patients frequently need various degrees of oxygen therapy up to non invasive ventilation (NIV-CPAP) and invasive mechanical ventilation (IMV).

Main purpose of this study is to evaluate with non invasive clinical instruments (pletysmography, Diffusion lung capacity for carbon monoxide -DLCO-, six minute walking test and dyspnea scores) and radiological tools (chest X-ray and chest CT scan) the development of medium-to-long term pulmonary sequelae caused by SARS-CoV-2 pneumonia.


Condition or disease
COVID Pneumonia, Viral Barotrauma Interstitial Lung Disease Bronchiectasis Adult Emphysema

Detailed Description:

SARS-CoV-2 related disease started in December 2019 in the Chinese city of Wuhan, rapidly spread and became an international health emergency.

Pneumonia is a frequent element of COVID-19, its pathogenic mechanisms are not entirely known and some patients develop various degrees of respiratory failure and need oxygen therapy up to NIV-CPAP) and IMV.

Some pathology studies in COVID-19 pneumonia show ARDS-like lesions associated to inflammatory reaction. It is known that pulmonary inflammatory damage can lead to fibrotic sequelae or to the development of pulmonary emphysema.

The main target of the study is to use non invasive methods (pletysmography, DLCO assessment, six minute walking test and dyspnea scores) and radiological tools (chest X-ray and chest CT scan) to identify pulmonary sequelae in patients hospitalised because of respiratory failure in COVID-19 pneumonia.

Study design: multicentre observational cohort study. Patients will be divided in three arms according to maximum ventilatory/oxygen support received during hospital stay:

  1. patients who received only oxygen therapy
  2. patients who received non invasive ventilation (NIV-CPAP)
  3. patients who received invasive mechanical ventilation (IMV)

All patients undergo a clinical evaluation at 6 months from hospital discharge (T1) and a second clinical evaluation at 12 months from hospital discharge (T2).

During (T1) patients undergo spirometry with pletysmography and DLCO assessment, six minute walking test, standard chest X-ray, arterial blood gas analysis if SaO2 < 93% in room air, dyspnea score and presence and extension of lung sounds at pulmonary auscultation.

During (T2) patients will undergo spirometry with pletysmography and DLCO assessment, six minute walking test, High Resolution CT scan (HRTC) of the thorax, arterial blood gas analysis if SaO2 < 93% in room air, dyspnea score and presence and extension of lung sounds at pulmonary auscultation).

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SequelaeCov: a Prospective Study on Lung Damage Caused by SARS-CoV-2 Pneumonia
Actual Study Start Date : August 17, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort
Oxygen therapy
Patients who were hospitalised due to COVID-19 pneumonia and received only oxygen support therapy.
Non invasive ventilation (NIV/CPAP)
Patients who were hospitalised due to COVID-19 pneumonia and received non invasive ventilation (NIV/CPAP) as maximum support therapy
Invasive ventilation
Patients who were hospitalised due to COVID-19 pneumonia and received invasive mechanical ventilation (IMV)



Primary Outcome Measures :
  1. Reduction of Diffusion of Lung CO (DLCO, single breath technique) [ Time Frame: T1 at 6 months from discharge ]
    Reduction below 80% of predicted values of DLCO

  2. Reduction of Diffusion of Lung CO (DLCO, single breath technique) [ Time Frame: T2 at 12 months from discharge ]
    Reduction below 80% of predicted values of DLCO


Secondary Outcome Measures :
  1. Alterations in 6 minute walking test (6MWT) [ Time Frame: T1 at 6 months from discharge ]
    reduction in maximum distance walked

  2. Alterations in 6 minute walking test (6MWT) [ Time Frame: T2 at 12 months from discharge ]
    reduction in maximum distance walked

  3. Alterations in 6 minute walking test (6MWT) [ Time Frame: T1 at 6 months from discharge ]
    reduction in oxygen saturation nadir

  4. Alterations in 6 minute walking test (6MWT) [ Time Frame: T2 at 12 months from discharge ]
    reduction in oxygen saturation nadir

  5. Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    reduction of Forced Vital Capacity (FVC, %)

  6. Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    reduction of Forced Vital Capacity (FVC, %)

  7. Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    reduction of Forced Vital Capacity (FVC, L)

  8. Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    reduction of Forced Vital Capacity (FVC, L)

  9. Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    reduction of Vital Capacity (VC, %)

  10. Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    reduction of Vital Capacity (VC, %)

  11. Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    reduction of Vital Capacity (VC, L)

  12. Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    reduction of Vital Capacity (VC, L)

  13. Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    reduction of Forced Expiratory Volume in the 1st second (FEV1, L)

  14. Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    reduction of Forced Expiratory Volume in the 1st second (FEV1, %)

  15. Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    reduction of Forced Expiratory Volume in the 1st second (FEV1, L)

  16. Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    reduction of Forced Expiratory Volume in the 1st second (FEV1, L%)

  17. Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    reduction of Total Lung Capacity (TLC, L)

  18. Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    reduction of Total Lung Capacity (TLC, %)

  19. Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    reduction of Total Lung Capacity (TLC, L)

  20. Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    reduction of Total Lung Capacity (TLC, %)

  21. Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    alterations of Residual Volume (RV,%)

  22. Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    alterations of Residual Volume (RV, L)

  23. Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    alterations of Residual Volume (RV, L)

  24. Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    alterations of Residual Volume (RV, %)

  25. Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    increase of Specific Airway Resistance (sRAW) (absolute value)

  26. Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    increase of Specific Airway Resistance (sRAW) (%)

  27. Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    increase of Specific Airway Resistance (sRAW) (absolute value)

  28. Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    increase of Specific Airway Resistance (sRAW) (%)

  29. Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    alterations of Motley Index (VR/CPT)

  30. Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    alterations of Motley Index (VR/CPT)

  31. Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    alterations of Tiffeneau Index (IT)

  32. Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    alterations of Tiffeneau Index (IT)

  33. Alterations of Arterial Blood Gas Analysis [ Time Frame: T1 at 6 months from discharge ]
    reduction of PaO2 mmHg

  34. Alterations of Arterial Blood Gas Analysis [ Time Frame: T2 at 12 months from discharge ]
    reduction of PaO2 mmHg

  35. Alterations of Arterial Blood Gas Analysis [ Time Frame: T1 at 6 months from discharge ]
    alteration of PaCO2 mmHg

  36. Alterations of Arterial Blood Gas Analysis [ Time Frame: T2 at 12 months from discharge ]
    alteration of PaCO2 mmHg

  37. Abnormal Dyspnea Score [ Time Frame: T1 at 6 months from discharge ]
    Modified Medical Research Council - mMRC > 0 (minimum 0, maximum 4; higher score means worse outcome)

  38. Abnormal Dyspnea Score [ Time Frame: T2 at 12 months from discharge ]
    Modified Medical Research Council - mMRC > 0(minimum 0, maximum 4; higher score means worse outcome)

  39. Presence and extension of abnormal pulmonary lung sounds at auscultation [ Time Frame: T1 at 6 months from discharge ]
    Presence and extension of abnormal pulmonary lung sounds at auscultation

  40. Presence and extension of abnormal pulmonary lung sounds at auscultation [ Time Frame: T2 at 12 months from discharge ]
    Presence and extension of abnormal pulmonary lung sounds at auscultation

  41. Presence and extension of radiological alterations at chest X-ray [ Time Frame: T1 at 6 months from discharge ]
    Presence and extension of radiological alterations at chest X-ray

  42. Presence and extension of radiological alterations at chest CT scan [ Time Frame: T2 at 12 months from discharge ]
    Presence and extension of radiological alterations at chest CT scan



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 to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with respiratory failure (P/F < 300) due to SARS-CoV-2 pneumonia
Criteria

Inclusion Criteria:

  • Age ≥ 18 and ≤ 80 years
  • Able to sign informed consent to participate in the study
  • Real time PCR diagnosis od SARS-CoV-2 infection
  • Hospital admission due to clinical/instrumental diagnosis of interstitial pneumonia
  • Presence of acute respiratory failure (PaO2/FiO2 <300 mm Hg) at the moment of hospital admission

Exclusion Criteria:

  • Severe renal failure defined as glomerular filtration rate (GFR) < 30 ml/min at hospital discharge
  • Cardiovascular failure NYHA class IV (patient unable to perform any activity) at hospital discharge
  • Active solid or hematological malignancies at hospital discharge
  • Prior diagnosis of chronic obstructive pulmonary disease (COPD), pulmonary emphysema, pulmonary fibrosis, bronchiectasis associated or not associated to cystic fibrosis
  • Pregnancy or breastfeeding
  • Suspected bacterial or fungine pulmonary superinfection during hospital stay

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): NCT04435327


Contacts
Layout table for location contacts
Contact: Paola Faverio, MD +390392339040 paola.faverio@unimib.it

Locations
Layout table for location information
Italy
San Gerardo Hospital Recruiting
Monza, MB, Italy, 20900
Contact: Paola Faverio, MD       paola.faverio@unimib.it   
Sponsors and Collaborators
University of Milano Bicocca
Layout table for additonal information
Responsible Party: University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT04435327    
Other Study ID Numbers: SequelaeCov
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia, Viral
Pneumonia
Lung Diseases
Bronchiectasis
Lung Diseases, Interstitial
Emphysema
Barotrauma
Respiratory Tract Diseases
Respiratory Tract Infections
Pathologic Processes
Bronchial Diseases
Virus Diseases
Wounds and Injuries