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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04435327
Recruitment Status : Completed
First Posted : June 17, 2020
Last Update Posted : May 4, 2022
Sponsor:
Information provided by (Responsible Party):
University of Milano Bicocca

Tracking Information
First Submitted Date June 12, 2020
First Posted Date June 17, 2020
Last Update Posted Date May 4, 2022
Actual Study Start Date October 5, 2020
Actual Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 16, 2020)
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 16, 2020)
  • Alterations in 6 minute walking test (6MWT) [ Time Frame: T1 at 6 months from discharge ]
    reduction in maximum distance walked
  • Alterations in 6 minute walking test (6MWT) [ Time Frame: T2 at 12 months from discharge ]
    reduction in maximum distance walked
  • Alterations in 6 minute walking test (6MWT) [ Time Frame: T1 at 6 months from discharge ]
    reduction in oxygen saturation nadir
  • Alterations in 6 minute walking test (6MWT) [ Time Frame: T2 at 12 months from discharge ]
    reduction in oxygen saturation nadir
  • Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    reduction of Forced Vital Capacity (FVC, %)
  • Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    reduction of Forced Vital Capacity (FVC, %)
  • Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    reduction of Forced Vital Capacity (FVC, L)
  • Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    reduction of Forced Vital Capacity (FVC, L)
  • Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    reduction of Vital Capacity (VC, %)
  • Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    reduction of Vital Capacity (VC, %)
  • Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    reduction of Vital Capacity (VC, L)
  • Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    reduction of Vital Capacity (VC, L)
  • Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    reduction of Forced Expiratory Volume in the 1st second (FEV1, L)
  • Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    reduction of Forced Expiratory Volume in the 1st second (FEV1, %)
  • Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    reduction of Forced Expiratory Volume in the 1st second (FEV1, L)
  • Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    reduction of Forced Expiratory Volume in the 1st second (FEV1, L%)
  • Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    reduction of Total Lung Capacity (TLC, L)
  • Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    reduction of Total Lung Capacity (TLC, %)
  • Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    reduction of Total Lung Capacity (TLC, L)
  • Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    reduction of Total Lung Capacity (TLC, %)
  • Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    alterations of Residual Volume (RV,%)
  • Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    alterations of Residual Volume (RV, L)
  • Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    alterations of Residual Volume (RV, L)
  • Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    alterations of Residual Volume (RV, %)
  • Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    increase of Specific Airway Resistance (sRAW) (absolute value)
  • Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    increase of Specific Airway Resistance (sRAW) (%)
  • Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    increase of Specific Airway Resistance (sRAW) (absolute value)
  • Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    increase of Specific Airway Resistance (sRAW) (%)
  • Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    alterations of Motley Index (VR/CPT)
  • Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    alterations of Motley Index (VR/CPT)
  • Alterations of pletismography [ Time Frame: T1 at 6 months from discharge ]
    alterations of Tiffeneau Index (IT)
  • Alterations of pletismography [ Time Frame: T2 at 12 months from discharge ]
    alterations of Tiffeneau Index (IT)
  • Alterations of Arterial Blood Gas Analysis [ Time Frame: T1 at 6 months from discharge ]
    reduction of PaO2 mmHg
  • Alterations of Arterial Blood Gas Analysis [ Time Frame: T2 at 12 months from discharge ]
    reduction of PaO2 mmHg
  • Alterations of Arterial Blood Gas Analysis [ Time Frame: T1 at 6 months from discharge ]
    alteration of PaCO2 mmHg
  • Alterations of Arterial Blood Gas Analysis [ Time Frame: T2 at 12 months from discharge ]
    alteration of PaCO2 mmHg
  • 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)
  • 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)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Lung Damage Caused by SARS-CoV-2 Pneumonia (COVID-19)
Official Title SequelaeCov: a Prospective Study on Lung Damage Caused by SARS-CoV-2 Pneumonia
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with respiratory failure (P/F < 300) due to SARS-CoV-2 pneumonia
Condition
  • COVID
  • Pneumonia, Viral
  • Barotrauma
  • Interstitial Lung Disease
  • Bronchiectasis Adult
  • Emphysema
Intervention Not Provided
Study Groups/Cohorts
  • 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)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 16, 2020)
300
Original Estimated Enrollment Same as current
Actual Study Completion Date March 18, 2022
Actual Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04435327
Other Study ID Numbers SequelaeCov
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party University of Milano Bicocca
Original Responsible Party Same as current
Current Study Sponsor University of Milano Bicocca
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Milano Bicocca
Verification Date January 2022