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Completed

NCT Number: NCT04435327

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

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.

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Key information

About this study

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:

  • patients who received only oxygen therapy
  • patients who received non invasive ventilation (NIV-CPAP)
  • 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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Registry information

Official study title

SequelaeCov: a Prospective Study on Lung Damage Caused by SARS-CoV-2 Pneumonia

Acronym: SequelaeCov

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jun 17, 2020
Registry last updated
May 4, 2022

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.

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