<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04435327</url>
  </required_header>
  <id_info>
    <org_study_id>SequelaeCov</org_study_id>
    <nct_id>NCT04435327</nct_id>
  </id_info>
  <brief_title>Lung Damage Caused by SARS-CoV-2 Pneumonia (COVID-19)</brief_title>
  <acronym>SequelaeCov</acronym>
  <official_title>SequelaeCov: a Prospective Study on Lung Damage Caused by SARS-CoV-2 Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Milano Bicocca</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Milano Bicocca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pneumonia is a recurrent element of COVID-19 infection, it is often associated with&#xD;
      development of respiratory failure and patients frequently need various degrees of oxygen&#xD;
      therapy up to non invasive ventilation (NIV-CPAP) and invasive mechanical ventilation (IMV).&#xD;
&#xD;
      Main purpose of this study is to evaluate with non invasive clinical instruments&#xD;
      (pletysmography, Diffusion lung capacity for carbon monoxide -DLCO-, six minute walking test&#xD;
      and dyspnea scores) and radiological tools (chest X-ray and chest CT scan) the development of&#xD;
      medium-to-long term pulmonary sequelae caused by SARS-CoV-2 pneumonia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SARS-CoV-2 related disease started in December 2019 in the Chinese city of Wuhan, rapidly&#xD;
      spread and became an international health emergency.&#xD;
&#xD;
      Pneumonia is a frequent element of COVID-19, its pathogenic mechanisms are not entirely known&#xD;
      and some patients develop various degrees of respiratory failure and need oxygen therapy up&#xD;
      to NIV-CPAP) and IMV.&#xD;
&#xD;
      Some pathology studies in COVID-19 pneumonia show ARDS-like lesions associated to&#xD;
      inflammatory reaction. It is known that pulmonary inflammatory damage can lead to fibrotic&#xD;
      sequelae or to the development of pulmonary emphysema.&#xD;
&#xD;
      The main target of the study is to use non invasive methods (pletysmography, DLCO assessment,&#xD;
      six minute walking test and dyspnea scores) and radiological tools (chest X-ray and chest CT&#xD;
      scan) to identify pulmonary sequelae in patients hospitalised because of respiratory failure&#xD;
      in COVID-19 pneumonia.&#xD;
&#xD;
      Study design: multicentre observational cohort study. Patients will be divided in three arms&#xD;
      according to maximum ventilatory/oxygen support received during hospital stay:&#xD;
&#xD;
        1. patients who received only oxygen therapy&#xD;
&#xD;
        2. patients who received non invasive ventilation (NIV-CPAP)&#xD;
&#xD;
        3. patients who received invasive mechanical ventilation (IMV)&#xD;
&#xD;
      All patients undergo a clinical evaluation at 6 months from hospital discharge (T1) and a&#xD;
      second clinical evaluation at 12 months from hospital discharge (T2).&#xD;
&#xD;
      During (T1) patients undergo spirometry with pletysmography and DLCO assessment, six minute&#xD;
      walking test, standard chest X-ray, arterial blood gas analysis if SaO2 &lt; 93% in room air,&#xD;
      dyspnea score and presence and extension of lung sounds at pulmonary auscultation.&#xD;
&#xD;
      During (T2) patients will undergo spirometry with pletysmography and DLCO assessment, six&#xD;
      minute walking test, High Resolution CT scan (HRTC) of the thorax, arterial blood gas&#xD;
      analysis if SaO2 &lt; 93% in room air, dyspnea score and presence and extension of lung sounds&#xD;
      at pulmonary auscultation).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2020</start_date>
  <completion_date type="Actual">March 18, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of Diffusion of Lung CO (DLCO, single breath technique)</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>Reduction below 80% of predicted values of DLCO</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduction of Diffusion of Lung CO (DLCO, single breath technique)</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>Reduction below 80% of predicted values of DLCO</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alterations in 6 minute walking test (6MWT)</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>reduction in maximum distance walked</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations in 6 minute walking test (6MWT)</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>reduction in maximum distance walked</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations in 6 minute walking test (6MWT)</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>reduction in oxygen saturation nadir</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations in 6 minute walking test (6MWT)</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>reduction in oxygen saturation nadir</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>reduction of Forced Vital Capacity (FVC, %)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>reduction of Forced Vital Capacity (FVC, %)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>reduction of Forced Vital Capacity (FVC, L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>reduction of Forced Vital Capacity (FVC, L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>reduction of Vital Capacity (VC, %)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>reduction of Vital Capacity (VC, %)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>reduction of Vital Capacity (VC, L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>reduction of Vital Capacity (VC, L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>reduction of Forced Expiratory Volume in the 1st second (FEV1, L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>reduction of Forced Expiratory Volume in the 1st second (FEV1, %)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>reduction of Forced Expiratory Volume in the 1st second (FEV1, L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>reduction of Forced Expiratory Volume in the 1st second (FEV1, L%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>reduction of Total Lung Capacity (TLC, L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>reduction of Total Lung Capacity (TLC, %)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>reduction of Total Lung Capacity (TLC, L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>reduction of Total Lung Capacity (TLC, %)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>alterations of Residual Volume (RV,%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>alterations of Residual Volume (RV, L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>alterations of Residual Volume (RV, L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>alterations of Residual Volume (RV, %)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>increase of Specific Airway Resistance (sRAW) (absolute value)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>increase of Specific Airway Resistance (sRAW) (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>increase of Specific Airway Resistance (sRAW) (absolute value)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>increase of Specific Airway Resistance (sRAW) (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>alterations of Motley Index (VR/CPT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>alterations of Motley Index (VR/CPT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>alterations of Tiffeneau Index (IT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of pletismography</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>alterations of Tiffeneau Index (IT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of Arterial Blood Gas Analysis</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>reduction of PaO2 mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of Arterial Blood Gas Analysis</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>reduction of PaO2 mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of Arterial Blood Gas Analysis</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>alteration of PaCO2 mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alterations of Arterial Blood Gas Analysis</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>alteration of PaCO2 mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abnormal Dyspnea Score</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>Modified Medical Research Council - mMRC &gt; 0 (minimum 0, maximum 4; higher score means worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abnormal Dyspnea Score</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>Modified Medical Research Council - mMRC &gt; 0(minimum 0, maximum 4; higher score means worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence and extension of abnormal pulmonary lung sounds at auscultation</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>Presence and extension of abnormal pulmonary lung sounds at auscultation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence and extension of abnormal pulmonary lung sounds at auscultation</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>Presence and extension of abnormal pulmonary lung sounds at auscultation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence and extension of radiological alterations at chest X-ray</measure>
    <time_frame>T1 at 6 months from discharge</time_frame>
    <description>Presence and extension of radiological alterations at chest X-ray</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence and extension of radiological alterations at chest CT scan</measure>
    <time_frame>T2 at 12 months from discharge</time_frame>
    <description>Presence and extension of radiological alterations at chest CT scan</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>COVID</condition>
  <condition>Pneumonia, Viral</condition>
  <condition>Barotrauma</condition>
  <condition>Interstitial Lung Disease</condition>
  <condition>Bronchiectasis Adult</condition>
  <condition>Emphysema</condition>
  <arm_group>
    <arm_group_label>Oxygen therapy</arm_group_label>
    <description>Patients who were hospitalised due to COVID-19 pneumonia and received only oxygen support therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non invasive ventilation (NIV/CPAP)</arm_group_label>
    <description>Patients who were hospitalised due to COVID-19 pneumonia and received non invasive ventilation (NIV/CPAP) as maximum support therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Invasive ventilation</arm_group_label>
    <description>Patients who were hospitalised due to COVID-19 pneumonia and received invasive mechanical ventilation (IMV)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with respiratory failure (P/F &lt; 300) due to SARS-CoV-2 pneumonia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 and ≤ 80 years&#xD;
&#xD;
          -  Able to sign informed consent to participate in the study&#xD;
&#xD;
          -  Real time PCR diagnosis od SARS-CoV-2 infection&#xD;
&#xD;
          -  Hospital admission due to clinical/instrumental diagnosis of interstitial pneumonia&#xD;
&#xD;
          -  Presence of acute respiratory failure (PaO2/FiO2 &lt;300 mm Hg) at the moment of hospital&#xD;
             admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe renal failure defined as glomerular filtration rate (GFR) &lt; 30 ml/min at&#xD;
             hospital discharge&#xD;
&#xD;
          -  Cardiovascular failure NYHA class IV (patient unable to perform any activity) at&#xD;
             hospital discharge&#xD;
&#xD;
          -  Active solid or hematological malignancies at hospital discharge&#xD;
&#xD;
          -  Prior diagnosis of chronic obstructive pulmonary disease (COPD), pulmonary emphysema,&#xD;
             pulmonary fibrosis, bronchiectasis associated or not associated to cystic fibrosis&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Suspected bacterial or fungine pulmonary superinfection during hospital stay&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>San Gerardo Hospital</name>
      <address>
        <city>Monza</city>
        <state>MB</state>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>34515212</PMID>
  </results_reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>April 27, 2022</last_update_submitted>
  <last_update_submitted_qc>April 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Pneumonia, Viral</mesh_term>
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Interstitial</mesh_term>
    <mesh_term>Bronchiectasis</mesh_term>
    <mesh_term>Emphysema</mesh_term>
    <mesh_term>Barotrauma</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04435327
org study id: SequelaeCov
nct id: NCT04435327
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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).
observational model: Cohort
time perspective: Prospective
measure: Reduction of Diffusion of Lung CO (DLCO, single breath technique)
time frame: T1 at 6 months from discharge
description: Reduction below 80% of predicted values of DLCO
measure: Reduction of Diffusion of Lung CO (DLCO, single breath technique)
time frame: T2 at 12 months from discharge
description: Reduction below 80% of predicted values of DLCO
measure: Alterations in 6 minute walking test (6MWT)
time frame: T1 at 6 months from discharge
description: reduction in maximum distance walked
measure: Alterations in 6 minute walking test (6MWT)
time frame: T2 at 12 months from discharge
description: reduction in maximum distance walked
measure: Alterations in 6 minute walking test (6MWT)
time frame: T1 at 6 months from discharge
description: reduction in oxygen saturation nadir
measure: Alterations in 6 minute walking test (6MWT)
time frame: T2 at 12 months from discharge
description: reduction in oxygen saturation nadir
measure: Alterations of pletismography
time frame: T1 at 6 months from discharge
description: reduction of Forced Vital Capacity (FVC, %)
measure: Alterations of pletismography
time frame: T2 at 12 months from discharge
description: reduction of Forced Vital Capacity (FVC, %)
measure: Alterations of pletismography
time frame: T1 at 6 months from discharge
description: reduction of Forced Vital Capacity (FVC, L)
measure: Alterations of pletismography
time frame: T2 at 12 months from discharge
description: reduction of Forced Vital Capacity (FVC, L)
measure: Alterations of pletismography
time frame: T1 at 6 months from discharge
description: reduction of Vital Capacity (VC, %)
measure: Alterations of pletismography
time frame: T2 at 12 months from discharge
description: reduction of Vital Capacity (VC, %)
measure: Alterations of pletismography
time frame: T1 at 6 months from discharge
description: reduction of Vital Capacity (VC, L)
measure: Alterations of pletismography
time frame: T2 at 12 months from discharge
description: reduction of Vital Capacity (VC, L)
measure: Alterations of pletismography
time frame: T1 at 6 months from discharge
description: reduction of Forced Expiratory Volume in the 1st second (FEV1, L)
measure: Alterations of pletismography
time frame: T1 at 6 months from discharge
description: reduction of Forced Expiratory Volume in the 1st second (FEV1, %)
measure: Alterations of pletismography
time frame: T2 at 12 months from discharge
description: reduction of Forced Expiratory Volume in the 1st second (FEV1, L)
measure: Alterations of pletismography
time frame: T2 at 12 months from discharge
description: reduction of Forced Expiratory Volume in the 1st second (FEV1, L%)
measure: Alterations of pletismography
time frame: T1 at 6 months from discharge
description: reduction of Total Lung Capacity (TLC, L)
measure: Alterations of pletismography
time frame: T1 at 6 months from discharge
description: reduction of Total Lung Capacity (TLC, %)
measure: Alterations of pletismography
time frame: T2 at 12 months from discharge
description: reduction of Total Lung Capacity (TLC, L)
measure: Alterations of pletismography
time frame: T2 at 12 months from discharge
description: reduction of Total Lung Capacity (TLC, %)
measure: Alterations of pletismography
time frame: T1 at 6 months from discharge
description: alterations of Residual Volume (RV,%)
measure: Alterations of pletismography
time frame: T1 at 6 months from discharge
description: alterations of Residual Volume (RV, L)
measure: Alterations of pletismography
time frame: T2 at 12 months from discharge
description: alterations of Residual Volume (RV, L)
measure: Alterations of pletismography
time frame: T2 at 12 months from discharge
description: alterations of Residual Volume (RV, %)
measure: Alterations of pletismography
time frame: T1 at 6 months from discharge
description: increase of Specific Airway Resistance (sRAW) (absolute value)
measure: Alterations of pletismography
time frame: T1 at 6 months from discharge
description: increase of Specific Airway Resistance (sRAW) (%)
measure: Alterations of pletismography
time frame: T2 at 12 months from discharge
description: increase of Specific Airway Resistance (sRAW) (absolute value)
measure: Alterations of pletismography
time frame: T2 at 12 months from discharge
description: increase of Specific Airway Resistance (sRAW) (%)
measure: Alterations of pletismography
time frame: T1 at 6 months from discharge
description: alterations of Motley Index (VR/CPT)
measure: Alterations of pletismography
time frame: T2 at 12 months from discharge
description: alterations of Motley Index (VR/CPT)
measure: Alterations of pletismography
time frame: T1 at 6 months from discharge
description: alterations of Tiffeneau Index (IT)
measure: Alterations of pletismography
time frame: T2 at 12 months from discharge
description: alterations of Tiffeneau Index (IT)
measure: Alterations of Arterial Blood Gas Analysis
time frame: T1 at 6 months from discharge
description: reduction of PaO2 mmHg
measure: Alterations of Arterial Blood Gas Analysis
time frame: T2 at 12 months from discharge
description: reduction of PaO2 mmHg
measure: Alterations of Arterial Blood Gas Analysis
time frame: T1 at 6 months from discharge
description: alteration of PaCO2 mmHg
measure: Alterations of Arterial Blood Gas Analysis
time frame: T2 at 12 months from discharge
description: alteration of PaCO2 mmHg
measure: Abnormal Dyspnea Score
time frame: T1 at 6 months from discharge
description: Modified Medical Research Council - mMRC > 0 (minimum 0, maximum 4; higher score means worse outcome)
measure: Abnormal Dyspnea Score
time frame: T2 at 12 months from discharge
description: Modified Medical Research Council - mMRC > 0(minimum 0, maximum 4; higher score means worse outcome)
measure: Presence and extension of abnormal pulmonary lung sounds at auscultation
time frame: T1 at 6 months from discharge
description: Presence and extension of abnormal pulmonary lung sounds at auscultation
measure: Presence and extension of abnormal pulmonary lung sounds at auscultation
time frame: T2 at 12 months from discharge
description: Presence and extension of abnormal pulmonary lung sounds at auscultation
measure: Presence and extension of radiological alterations at chest X-ray
time frame: T1 at 6 months from discharge
description: Presence and extension of radiological alterations at chest X-ray
measure: Presence and extension of radiological alterations at chest CT scan
time frame: T2 at 12 months from discharge
description: Presence and extension of radiological alterations at chest CT scan
arm group label: Oxygen therapy
description: Patients who were hospitalised due to COVID-19 pneumonia and received only oxygen support therapy.
arm group label: Non invasive ventilation (NIV/CPAP)
description: Patients who were hospitalised due to COVID-19 pneumonia and received non invasive ventilation (NIV/CPAP) as maximum support therapy
arm group label: Invasive ventilation
description: Patients who were hospitalised due to COVID-19 pneumonia and received invasive mechanical ventilation (IMV)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Italy
citation: 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
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Pneumonia, Viral
mesh term: Lung Diseases
mesh term: Lung Diseases, Interstitial
mesh term: Bronchiectasis
mesh term: Emphysema
mesh term: Barotrauma