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

NCT04435327 | Completed

• 1 other identifier: SequelaeCov
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Reduction of Diffusion of Lung CO (DLCO, single breath technique)

  Reduction below 80% of predicted values of DLCO

  T1 at 6 months from discharge

• Reduction of Diffusion of Lung CO (DLCO, single breath technique)

  Reduction below 80% of predicted values of DLCO

  T2 at 12 months from discharge

Secondary Outcomes (42)

• Alterations in 6 minute walking test (6MWT)

  T1 at 6 months from discharge

• Alterations in 6 minute walking test (6MWT)

  T2 at 12 months from discharge

• Alterations in 6 minute walking test (6MWT)

  T1 at 6 months from discharge

• Alterations in 6 minute walking test (6MWT)

  T2 at 12 months from discharge

• Alterations of pletismography

  T1 at 6 months from discharge

Study Arms (3)

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)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with respiratory failure (P/F \< 300) due to SARS-CoV-2 pneumonia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

San Gerardo Hospital

Monza, MB, 20900, Italy

Location

Related Publications (1)

• Faverio P, Luppi F, Rebora P, Busnelli S, Stainer A, Catalano M, Parachini L, Monzani A, Galimberti S, Bini F, Bodini BD, Betti M, De Giacomi F, Scarpazza P, Oggionni E, Scartabellati A, Bilucaglia L, Ceruti P, Modina D, Harari S, Caminati A, Valsecchi MG, Bellani G, Foti G, Pesci A. Six-Month Pulmonary Impairment after Severe COVID-19: A Prospective, Multicentre Follow-Up Study. Respiration. 2021;100(11):1078-1087. doi: 10.1159/000518141. Epub 2021 Aug 19.

  PMID: 34515212 RESULT

MeSH Terms

Conditions

Pneumonia, Viral; Barotrauma; Lung Diseases, Interstitial; Emphysema

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 17, 2020
• Study Start: October 5, 2020
• Primary Completion: December 31, 2021
• Study Completion: March 18, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-01

Locations

IT (1)