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

Sponsor

University of Milano Bicocca (Other)

Overall Status

Completed

CT.gov ID

NCT04435327

Collaborator

(none)

300

Enrollment

Location

17.4

Actual Duration (Months)

17.3

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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:

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).

Study Design

Study Type:

Observational

Actual 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 :

Oct 5, 2020

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Mar 18, 2022

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

Reduction of Diffusion of Lung CO (DLCO, single breath technique) [T1 at 6 months from discharge]
Reduction below 80% of predicted values of DLCO
Reduction of Diffusion of Lung CO (DLCO, single breath technique) [T2 at 12 months from discharge]
Reduction below 80% of predicted values of DLCO

Secondary Outcome Measures

Alterations in 6 minute walking test (6MWT) [T1 at 6 months from discharge]
reduction in maximum distance walked
Alterations in 6 minute walking test (6MWT) [T2 at 12 months from discharge]
reduction in maximum distance walked
Alterations in 6 minute walking test (6MWT) [T1 at 6 months from discharge]
reduction in oxygen saturation nadir
Alterations in 6 minute walking test (6MWT) [T2 at 12 months from discharge]
reduction in oxygen saturation nadir
Alterations of pletismography [T1 at 6 months from discharge]
reduction of Forced Vital Capacity (FVC, %)
Alterations of pletismography [T2 at 12 months from discharge]
reduction of Forced Vital Capacity (FVC, %)
Alterations of pletismography [T1 at 6 months from discharge]
reduction of Forced Vital Capacity (FVC, L)
Alterations of pletismography [T2 at 12 months from discharge]
reduction of Forced Vital Capacity (FVC, L)
Alterations of pletismography [T1 at 6 months from discharge]
reduction of Vital Capacity (VC, %)
Alterations of pletismography [T2 at 12 months from discharge]
reduction of Vital Capacity (VC, %)
Alterations of pletismography [T1 at 6 months from discharge]
reduction of Vital Capacity (VC, L)
Alterations of pletismography [T2 at 12 months from discharge]
reduction of Vital Capacity (VC, L)
Alterations of pletismography [T1 at 6 months from discharge]
reduction of Forced Expiratory Volume in the 1st second (FEV1, L)
Alterations of pletismography [T1 at 6 months from discharge]
reduction of Forced Expiratory Volume in the 1st second (FEV1, %)
Alterations of pletismography [T2 at 12 months from discharge]
reduction of Forced Expiratory Volume in the 1st second (FEV1, L)
Alterations of pletismography [T2 at 12 months from discharge]
reduction of Forced Expiratory Volume in the 1st second (FEV1, L%)
Alterations of pletismography [T1 at 6 months from discharge]
reduction of Total Lung Capacity (TLC, L)
Alterations of pletismography [T1 at 6 months from discharge]
reduction of Total Lung Capacity (TLC, %)
Alterations of pletismography [T2 at 12 months from discharge]
reduction of Total Lung Capacity (TLC, L)
Alterations of pletismography [T2 at 12 months from discharge]
reduction of Total Lung Capacity (TLC, %)
Alterations of pletismography [T1 at 6 months from discharge]
alterations of Residual Volume (RV,%)
Alterations of pletismography [T1 at 6 months from discharge]
alterations of Residual Volume (RV, L)
Alterations of pletismography [T2 at 12 months from discharge]
alterations of Residual Volume (RV, L)
Alterations of pletismography [T2 at 12 months from discharge]
alterations of Residual Volume (RV, %)
Alterations of pletismography [T1 at 6 months from discharge]
increase of Specific Airway Resistance (sRAW) (absolute value)
Alterations of pletismography [T1 at 6 months from discharge]
increase of Specific Airway Resistance (sRAW) (%)
Alterations of pletismography [T2 at 12 months from discharge]
increase of Specific Airway Resistance (sRAW) (absolute value)
Alterations of pletismography [T2 at 12 months from discharge]
increase of Specific Airway Resistance (sRAW) (%)
Alterations of pletismography [T1 at 6 months from discharge]
alterations of Motley Index (VR/CPT)
Alterations of pletismography [T2 at 12 months from discharge]
alterations of Motley Index (VR/CPT)
Alterations of pletismography [T1 at 6 months from discharge]
alterations of Tiffeneau Index (IT)
Alterations of pletismography [T2 at 12 months from discharge]
alterations of Tiffeneau Index (IT)
Alterations of Arterial Blood Gas Analysis [T1 at 6 months from discharge]
reduction of PaO2 mmHg
Alterations of Arterial Blood Gas Analysis [T2 at 12 months from discharge]
reduction of PaO2 mmHg
Alterations of Arterial Blood Gas Analysis [T1 at 6 months from discharge]
alteration of PaCO2 mmHg
Alterations of Arterial Blood Gas Analysis [T2 at 12 months from discharge]
alteration of PaCO2 mmHg
Abnormal Dyspnea Score [T1 at 6 months from discharge]
Modified Medical Research Council - mMRC > 0 (minimum 0, maximum 4; higher score means worse outcome)
Abnormal Dyspnea Score [T2 at 12 months from discharge]
Modified Medical Research Council - mMRC > 0(minimum 0, maximum 4; higher score means worse outcome)
Presence and extension of abnormal pulmonary lung sounds at auscultation [T1 at 6 months from discharge]
Presence and extension of abnormal pulmonary lung sounds at auscultation
Presence and extension of abnormal pulmonary lung sounds at auscultation [T2 at 12 months from discharge]
Presence and extension of abnormal pulmonary lung sounds at auscultation
Presence and extension of radiological alterations at chest X-ray [T1 at 6 months from discharge]
Presence and extension of radiological alterations at chest X-ray
Presence and extension of radiological alterations at chest CT scan [T2 at 12 months from discharge]
Presence and extension of radiological alterations at chest CT scan

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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