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

Completed

• Conditions: Interstitial Lung Disease; Pneumonia, Viral; Emphysema; Barotrauma; COVID; Bronchiectasis Adult

• Registration Number: NCT04435327
• Lead Sponsor: 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.

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).

Study Timeline

• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2020-06-16
• Study First Posted: 2020-06-17
• Study Start: 2020-10-05
• Primary Completion: 2021-12-31
• Status Verified: 2022-01
• Study Completion: 2022-03-18
• Last Update Submitted: 2022-04-27
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Alterations of Arterial Blood Gas Analysis	T2 at 12 months from discharge	alteration of PaCO2 mmHg
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	T2 at 12 months from discharge	Presence and extension of abnormal pulmonary lung sounds at auscultation
Alterations in 6 minute walking test (6MWT)	T2 at 12 months from discharge	reduction in oxygen saturation nadir
Alterations of pletismography	T2 at 12 months from discharge	alterations of Tiffeneau Index (IT)
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

Trial Locations

Locations (1)

San Gerardo Hospital; 🇮🇹 Monza, MB, Italy