<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/NCT04410107</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0169</org_study_id>
    <nct_id>NCT04410107</nct_id>
  </id_info>
  <brief_title>Lung Function, Exercise Capacity and Health-Related Quality of Life After Severe COVID-19</brief_title>
  <official_title>Short and Long Term Assessment of Lung Function, Exercise Capacity and Health-Related Quality of Life in Survivors of Severe COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Rio Grande do Sul</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Conselho Nacional de Desenvolvimento Científico e Tecnológico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Moinhos de Vento</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Federal University of Health Science of Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidade de Passo Fundo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Nossa Senhora da Conceicao</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of Rio Grande do Sul</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>
      Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly&#xD;
      emergent coronavirus (SARS-CoV-2) that can progress to severe disease requiring&#xD;
      hospitalization and oxygen support in around14% of the cases and 5% require admission in&#xD;
      intensive care unit. The medium and long-term impact in survivors of severe COVID-19 on lung&#xD;
      function, exercise capacity and health-related quality of life remains to be determined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a&#xD;
      newly emergent coronavirus (severe acute respiratory syndrome coronavirus 2; SARS-CoV-2) that&#xD;
      was first recognized in Wuhan, China, in December 2019. Currently, this infection reached&#xD;
      pandemic levels causing serious diseases in 14% of cases and the potential to progress to&#xD;
      acute respiratory distress syndrome (ARDS) with the need for invasive ventilatory support and&#xD;
      prolonged hospitalization in intensive care units (ICU). The overall lethality is 2% and the&#xD;
      lethality of cases admitted to the ICU varies from 26 to 50%. The medium and long-term impact&#xD;
      in survivors of severe COVID-19 on lung function, exercise capacity and health related&#xD;
      quality of life (HRQoL) remains to be determined.&#xD;
&#xD;
      Aims: To evaluate the early (Visit1: 2-6 months after acute disease) and late (Visit 2: 9-15&#xD;
      months and Visit 3: 18-24 months) effects of severe acute respiratory syndrome on lung&#xD;
      function, exercise capacity, respiratory symptoms and HRQoL in patients with confirmed&#xD;
      diagnosis of SARS-CoV-2 infection.&#xD;
&#xD;
      Material and methods: Prospective cohort of subjects with laboratory confirmed severe&#xD;
      COVID-19 (respiratory rate&gt; 30 breaths/ min; severe respiratory distress; oxyhemoglobin&#xD;
      saturation in room air ≤93% or pulmonary involvement&gt; 50% in chest images). Participants will&#xD;
      perform spirometry before and after bronchodilator, lung volumes by body plethysmography,&#xD;
      lung diffusion capacity of carbon monoxide, respiratory system resistance by impulse&#xD;
      oscillometry and 6-minute walk test (6MWT) after 2-6 months (Visit 1) , 9-15 months (Visit&#xD;
      2), and 18-24 months (Visit 3) of severe COVID-19. When abnormalities in these pulmonary&#xD;
      function tests and/or 6MWT were detected, a cardiopulmonary exercise test will be performed.&#xD;
      Clinical, laboratory and chest image data during the severe COVID-19 hospitalization will be&#xD;
      obtained from medical records.&#xD;
&#xD;
      The minimum sample size was estimated as 134 participants to assess at least 5 independent&#xD;
      factors to predict lung function, HRQoL and exercise capacity at the early assessment.&#xD;
      Notwithstanding, the investigators plan to invite to participate all survivors of severe&#xD;
      COVID-19 admitted in hospitals of the state of Rio Grande do Sul (Brazil).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 15, 2020</start_date>
  <completion_date type="Anticipated">July 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</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>Forced expiratory volume in the first second/forced vital capacity</measure>
    <time_frame>6 months</time_frame>
    <description>ratio obtained from measured values during spirometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total lung capacity</measure>
    <time_frame>6 months</time_frame>
    <description>obtained from plethysmography (% of predicted)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lung diffusion capacity for carbon monoxide</measure>
    <time_frame>6 months</time_frame>
    <description>obtained from single-breathe maneuver (% of predicted)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>6-minute walk test distance</measure>
    <time_frame>6 months</time_frame>
    <description>distance walked during the test (m)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short-form 36 questionnaire (SF-36)</measure>
    <time_frame>6 months</time_frame>
    <description>scores range between 0 and 100 with higher scores indicating a better HRQoL</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Forced expiratory volume in the first second/forced vital capacity</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>ratio obtained from measured values during spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced vital capacity</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>% of predicted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual volume/total lung capacity</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>ratio obtained from measured values during plethysmography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inspiratory capacity/total lung capacity</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>ratio obtained from measured values during plethysmography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Airway resistance (Raw)</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>obtained from body plethysmography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung diffusion capacity for carbon monoxide</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>obtained from single-breathe maneuver (% of predicted)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resistance at 20Hz and 5Hz (R5-R20)</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>obtained from Impulse oscillometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reactance at 5Hz (X5)</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>obtained from Impulse oscillometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resonant frequency (Fres)</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>obtained from Impulse oscillometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reactance area (AХ)</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>obtained from Impulse oscillometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-minute walk test distance</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>distance walked during the test (m)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse oximetry (SpO2) at rest</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>before 6-minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse oximetry (SpO2) during exercise</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>at the end of 6-minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory symptoms adapted from American Thoracic Society Questionnaire</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>descriptive/qualitative questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short-form 36 questionnaire (SF-36)</measure>
    <time_frame>12 and 24 months</time_frame>
    <description>scores range between 0 and 100 with higher scores indicating a better HRQoL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen uptake at peak exercise</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>from incremental Cardiopulmonary exercise test (% of predicted)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minute-ventilation/carbon dioxide output during exercise</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>from incremental Cardiopulmonary exercise test (L/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspnea during exercise</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>from incremental Cardiopulmonary exercise test (measured with 10-point categorical Borg scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inspiratory capacity during exercise</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>from incremental Cardiopulmonary exercise test (L and % of predicted)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Anxiety Inventory (BAI)</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>total score ranges from 0 to 63; higher score indicating higher anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory (BDI)</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>total scores ranges from 0 to 63; higher score is worse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-traumatic stress symptoms questionnaire</measure>
    <time_frame>6, 12 and 24 months</time_frame>
    <description>17-item, 5 likert-scale each item; higher score indicating more symptoms</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">134</enrollment>
  <condition>COVID-19</condition>
  <condition>SARS-CoV-2 Infection</condition>
  <arm_group>
    <arm_group_label>Severe Pneumonia</arm_group_label>
    <description>Presence of fever or suspected lower respiratory infection, plus one of the following criteria:&#xD;
1) respiratory rate&gt; 30 movements / min; 2) severe respiratory distress 3) Pulse oximetry (SpO2) ≤93% in room air; and/or 3) Pulmonary infiltrates&gt; 50% on chest imaging within 24-48hrs of symptom onset.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acute respiratory distress syndrome (ARDS)</arm_group_label>
    <description>Onset: acute, i.e. within 1 week of known clinical insult or new or worsening respiratory symptoms; and&#xD;
Chest imaging (e.g. X-ray or CT scan): bilateral opacities, not fully explained by effusions, lobar/lung collapse or nodules; and&#xD;
Origin of pulmonary edema: respiratory failure not fully explained by cardiac failure or fluid overload; and&#xD;
Degree of hypoxemia: arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) ≤ 300 mm Hg with positive end-expiratory pressure ≥ 5 cm H2O.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Lung Function tests</intervention_name>
    <description>Spirometry before and after bronchodilator, lung volumes by body plethysmography, lung diffusion capacity of carbon monoxide (DLCO), respiratory system resistance by impulse oscillometry (IOS)</description>
    <arm_group_label>Acute respiratory distress syndrome (ARDS)</arm_group_label>
    <arm_group_label>Severe Pneumonia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Exercise capacity</intervention_name>
    <description>6-minute walk test (6MWT distance)</description>
    <arm_group_label>Acute respiratory distress syndrome (ARDS)</arm_group_label>
    <arm_group_label>Severe Pneumonia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Exercise physiology</intervention_name>
    <description>Cardiopulmonary exercise test (CPET)</description>
    <arm_group_label>Acute respiratory distress syndrome (ARDS)</arm_group_label>
    <arm_group_label>Severe Pneumonia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Health-related quality of life</intervention_name>
    <description>Short-Form Health Survey Questionnaire (SF-36)</description>
    <arm_group_label>Acute respiratory distress syndrome (ARDS)</arm_group_label>
    <arm_group_label>Severe Pneumonia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening</intervention_name>
    <description>Adapted translation American Thoracic Society respiratory symptoms questionnaire;&#xD;
Beck Anxiety Inventory (BAI) and Beck's depression Inventory (BDI);&#xD;
Questionnaire for screening for post-traumatic stress symptoms (PTSD).</description>
    <arm_group_label>Acute respiratory distress syndrome (ARDS)</arm_group_label>
    <arm_group_label>Severe Pneumonia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects that survived severe COVID-19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previous laboratory confirmation of SARS-Cov-2 infection defined as a positive result&#xD;
             of reverse polymerase-transcriptase chain reaction test in real-time of a sample taken&#xD;
             by nasal and/or pharyngeal swab; and&#xD;
&#xD;
          -  Severe pneumonia defined by the presence of fever or suspected lower respiratory&#xD;
             infection, plus one of the following criteria: respiratory rate&gt; 30 movements/min;&#xD;
             severe respiratory distress; SpO2≤93% in room air; or pulmonary infiltrates&gt;50% on&#xD;
             chest imaging within 24-48hrs of acute symptoms onset; and/or&#xD;
&#xD;
          -  Acute respiratory distress syndrome (ARDS) defined according to COVID-19 operational&#xD;
             management guide of World Health Organization and classified as mild (200 mmHg &lt;PaO2 /&#xD;
             FiO2 ≤ 300 mmHg), moderate (100 mmHg &lt;PaO2 / FiO2 ≤ 200 mmHg) or severe (PaO2 / FiO2 ≤&#xD;
             100 mmHg). When the PaO2 is not available, SpO2 / FiO2 ≤ 315 suggests ARDS.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of clinical stability for 2 months before inclusion (including those who remain&#xD;
             hospitalized);&#xD;
&#xD;
          -  Active respiratory tract infection (of any cause); or&#xD;
&#xD;
          -  Any clinical condition that prevents the performance of the study procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Danilo C Berton, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal do Rio Grande do Sul/Hospital de Clínicas de Porto Alegre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade de Passo Fundo</name>
      <address>
        <city>Passo Fundo</city>
        <state>Rio Grande Do Sul</state>
        <zip>99052-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Moinhos de Vento</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90035-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre/Universidade Federal do Rio Grande do Sul</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90035-003</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univesidade de Ciências da Saúde de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90050-170</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nossa Senhora da Conceição</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>91350-200</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>December 19, 2022</last_update_submitted>
  <last_update_submitted_qc>December 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Rio Grande do Sul</investigator_affiliation>
    <investigator_full_name>Danilo C Berton, MD</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>Severe Acute Respiratory Syndrome Coronavirus 2</keyword>
  <keyword>Pneumonia</keyword>
  <keyword>Respiratory Distress Syndrome, Adult</keyword>
  <keyword>Respiratory Function Tests</keyword>
  <keyword>Exercise</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04410107
org study id: 2020-0169
nct id: NCT04410107
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly
      emergent coronavirus (SARS-CoV-2) that can progress to severe disease requiring
      hospitalization and oxygen support in around14% of the cases and 5% require admission in
      intensive care unit. The medium and long-term impact in survivors of severe COVID-19 on lung
      function, exercise capacity and health-related quality of life remains to be determined.
Background: Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a
      newly emergent coronavirus (severe acute respiratory syndrome coronavirus 2; SARS-CoV-2) that
      was first recognized in Wuhan, China, in December 2019. Currently, this infection reached
      pandemic levels causing serious diseases in 14% of cases and the potential to progress to
      acute respiratory distress syndrome (ARDS) with the need for invasive ventilatory support and
      prolonged hospitalization in intensive care units (ICU). The overall lethality is 2% and the
      lethality of cases admitted to the ICU varies from 26 to 50%. The medium and long-term impact
      in survivors of severe COVID-19 on lung function, exercise capacity and health related
      quality of life (HRQoL) remains to be determined.

      Aims: To evaluate the early (Visit1: 2-6 months after acute disease) and late (Visit 2: 9-15
      months and Visit 3: 18-24 months) effects of severe acute respiratory syndrome on lung
      function, exercise capacity, respiratory symptoms and HRQoL in patients with confirmed
      diagnosis of SARS-CoV-2 infection.

      Material and methods: Prospective cohort of subjects with laboratory confirmed severe
      COVID-19 (respiratory rate> 30 breaths/ min; severe respiratory distress; oxyhemoglobin
      saturation in room air ≤93% or pulmonary involvement> 50% in chest images). Participants will
      perform spirometry before and after bronchodilator, lung volumes by body plethysmography,
      lung diffusion capacity of carbon monoxide, respiratory system resistance by impulse
      oscillometry and 6-minute walk test (6MWT) after 2-6 months (Visit 1) , 9-15 months (Visit
      2), and 18-24 months (Visit 3) of severe COVID-19. When abnormalities in these pulmonary
      function tests and/or 6MWT were detected, a cardiopulmonary exercise test will be performed.
      Clinical, laboratory and chest image data during the severe COVID-19 hospitalization will be
      obtained from medical records.

      The minimum sample size was estimated as 134 participants to assess at least 5 independent
      factors to predict lung function, HRQoL and exercise capacity at the early assessment.
      Notwithstanding, the investigators plan to invite to participate all survivors of severe
      COVID-19 admitted in hospitals of the state of Rio Grande do Sul (Brazil).
observational model: Cohort
time perspective: Prospective
measure: Forced expiratory volume in the first second/forced vital capacity
time frame: 6 months
description: ratio obtained from measured values during spirometry
measure: Total lung capacity
time frame: 6 months
description: obtained from plethysmography (% of predicted)
measure: Lung diffusion capacity for carbon monoxide
time frame: 6 months
description: obtained from single-breathe maneuver (% of predicted)
measure: 6-minute walk test distance
time frame: 6 months
description: distance walked during the test (m)
measure: Short-form 36 questionnaire (SF-36)
time frame: 6 months
description: scores range between 0 and 100 with higher scores indicating a better HRQoL
measure: Forced expiratory volume in the first second/forced vital capacity
time frame: 12 and 24 months
description: ratio obtained from measured values during spirometry
measure: Forced vital capacity
time frame: 6, 12 and 24 months
description: % of predicted
measure: Residual volume/total lung capacity
time frame: 6, 12 and 24 months
description: ratio obtained from measured values during plethysmography
measure: Inspiratory capacity/total lung capacity
time frame: 6, 12 and 24 months
description: ratio obtained from measured values during plethysmography
measure: Airway resistance (Raw)
time frame: 6, 12 and 24 months
description: obtained from body plethysmography
measure: Lung diffusion capacity for carbon monoxide
time frame: 12 and 24 months
description: obtained from single-breathe maneuver (% of predicted)
measure: Resistance at 20Hz and 5Hz (R5-R20)
time frame: 6, 12 and 24 months
description: obtained from Impulse oscillometry
measure: Reactance at 5Hz (X5)
time frame: 6, 12 and 24 months
description: obtained from Impulse oscillometry
measure: Resonant frequency (Fres)
time frame: 6, 12 and 24 months
description: obtained from Impulse oscillometry
measure: Reactance area (AХ)
time frame: 6, 12 and 24 months
description: obtained from Impulse oscillometry
measure: 6-minute walk test distance
time frame: 12 and 24 months
description: distance walked during the test (m)
measure: Pulse oximetry (SpO2) at rest
time frame: 6, 12 and 24 months
description: before 6-minute walk test
measure: Pulse oximetry (SpO2) during exercise
time frame: 6, 12 and 24 months
description: at the end of 6-minute walk test
measure: Respiratory symptoms adapted from American Thoracic Society Questionnaire
time frame: 6, 12 and 24 months
description: descriptive/qualitative questionnaire
measure: Short-form 36 questionnaire (SF-36)
time frame: 12 and 24 months
description: scores range between 0 and 100 with higher scores indicating a better HRQoL
measure: Oxygen uptake at peak exercise
time frame: 6, 12 and 24 months
description: from incremental Cardiopulmonary exercise test (% of predicted)
measure: Minute-ventilation/carbon dioxide output during exercise
time frame: 6, 12 and 24 months
description: from incremental Cardiopulmonary exercise test (L/L)
measure: Dyspnea during exercise
time frame: 6, 12 and 24 months
description: from incremental Cardiopulmonary exercise test (measured with 10-point categorical Borg scale)
measure: Inspiratory capacity during exercise
time frame: 6, 12 and 24 months
description: from incremental Cardiopulmonary exercise test (L and % of predicted)
measure: Beck Anxiety Inventory (BAI)
time frame: 6, 12 and 24 months
description: total score ranges from 0 to 63; higher score indicating higher anxiety
measure: Beck Depression Inventory (BDI)
time frame: 6, 12 and 24 months
description: total scores ranges from 0 to 63; higher score is worse
measure: Post-traumatic stress symptoms questionnaire
time frame: 6, 12 and 24 months
description: 17-item, 5 likert-scale each item; higher score indicating more symptoms
arm group label: Severe Pneumonia
description: Presence of fever or suspected lower respiratory infection, plus one of the following criteria:
1) respiratory rate> 30 movements / min; 2) severe respiratory distress 3) Pulse oximetry (SpO2) ≤93% in room air; and/or 3) Pulmonary infiltrates> 50% on chest imaging within 24-48hrs of symptom onset.
arm group label: Acute respiratory distress syndrome (ARDS)
description: Onset: acute, i.e. within 1 week of known clinical insult or new or worsening respiratory symptoms; and
Chest imaging (e.g. X-ray or CT scan): bilateral opacities, not fully explained by effusions, lobar/lung collapse or nodules; and
Origin of pulmonary edema: respiratory failure not fully explained by cardiac failure or fluid overload; and
Degree of hypoxemia: arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) ≤ 300 mm Hg with positive end-expiratory pressure ≥ 5 cm H2O.
intervention type: Diagnostic Test
intervention name: Lung Function tests
description: Spirometry before and after bronchodilator, lung volumes by body plethysmography, lung diffusion capacity of carbon monoxide (DLCO), respiratory system resistance by impulse oscillometry (IOS)
arm group label: Acute respiratory distress syndrome (ARDS)
arm group label: Severe Pneumonia
intervention type: Diagnostic Test
intervention name: Exercise capacity
description: 6-minute walk test (6MWT distance)
arm group label: Acute respiratory distress syndrome (ARDS)
arm group label: Severe Pneumonia
intervention type: Diagnostic Test
intervention name: Exercise physiology
description: Cardiopulmonary exercise test (CPET)
arm group label: Acute respiratory distress syndrome (ARDS)
arm group label: Severe Pneumonia
intervention type: Diagnostic Test
intervention name: Health-related quality of life
description: Short-Form Health Survey Questionnaire (SF-36)
arm group label: Acute respiratory distress syndrome (ARDS)
arm group label: Severe Pneumonia
intervention type: Diagnostic Test
intervention name: Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening
description: Adapted translation American Thoracic Society respiratory symptoms questionnaire;
Beck Anxiety Inventory (BAI) and Beck's depression Inventory (BDI);
Questionnaire for screening for post-traumatic stress symptoms (PTSD).
arm group label: Acute respiratory distress syndrome (ARDS)
arm group label: Severe Pneumonia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Danilo C Berton, Dr
role: Principal Investigator
affiliation: Universidade Federal do Rio Grande do Sul/Hospital de Clínicas de Porto Alegre
facility: 
facility: 
facility: 
facility: 
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Rio Grande do Sul
investigator full name: Danilo C Berton, MD
investigator title: Dr
mesh term: COVID-19