<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/NCT04401254</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-Recovery V1.5 9Feb2022</org_study_id>
    <nct_id>NCT04401254</nct_id>
  </id_info>
  <brief_title>Recovery of Patients From COVID-19 After Critical Illness</brief_title>
  <official_title>The Coronavirus Disease 2019 - Recovery Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Australian and New Zealand Intensive Care Research Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Alfred</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Australian and New Zealand Intensive Care Research Centre</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>
      Patients who are critically ill with COVID-19 requiring life support in an intensive care&#xD;
      unit (ICU) have increased risk of morbidity and mortality. Currently the ICU community does&#xD;
      not know what effect the disease, the ICU admission, physiotherapy interventions and life&#xD;
      support have on their long-term quality of life and whether they can return to their&#xD;
      pre-illness level of function following ICU.&#xD;
&#xD;
      COVID-Recovery will describe the physiotherapy interventions delivered to critically ill&#xD;
      patients with COVID-19. In survivors, COVID-Recovery will utilise telephone follow-up of ICU&#xD;
      survivors to assess disability-free survival and quality of life at 6 months after ICU&#xD;
      admission. Additionally, COVID-Recovery will identify if there are predictors of&#xD;
      disability-free survival. COVID-Recovery will aim to select up to 300 patients diagnosed with&#xD;
      COVID-19 from ICUs in Australia. If they survive to hospital discharge, patients will be&#xD;
      invited to receive a telephone questionnaire at 6 months after the ICU admission that aims to&#xD;
      assess their long-term outcomes, including physical, cognitive and emotional function,&#xD;
      quality of life, and whether they have been able to return to work following ICU discharge.&#xD;
&#xD;
      To describe the experience of critical illness in survivors of COVID-19 and their family&#xD;
      members.&#xD;
&#xD;
      To explore and describe functional recovery, respiratory system function and respiratory&#xD;
      health morbidity up to 6 months after ICU admission in persistently critically ill adults&#xD;
      with COVID-19&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">July 30, 2022</completion_date>
  <primary_completion_date type="Actual">July 30, 2022</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>Disability-free survival</measure>
    <time_frame>6 months</time_frame>
    <description>a composite measure of WHODAS 2.0 - 12 level and hospital survival</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physiotherapy intervention</measure>
    <time_frame>During the ICU stay until 3 months</time_frame>
    <description>The physiotherapy interventions provided to patients with COVID-19 admitted to the ICU and health outcomes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health status</measure>
    <time_frame>6 months</time_frame>
    <description>Health related quality of life measured with EQ5D-5L score from 0 to 100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global function</measure>
    <time_frame>6 months</time_frame>
    <description>World Health Organization Disability Assessment Schedule 2.0 12L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function</measure>
    <time_frame>6 months</time_frame>
    <description>Montreal Cognitive Assessment Blind</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression</measure>
    <time_frame>6 months</time_frame>
    <description>Hospital Anxiety and Depression Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Screening for post-traumatic distress</measure>
    <time_frame>6 months</time_frame>
    <description>Impact of Events Scale Revised</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work Status</measure>
    <time_frame>6 months</time_frame>
    <description>WHODAS 2.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with COVID-19 who received physiotherapy in ICU</measure>
    <time_frame>During the ICU stay until 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The reported barriers to delivering physiotherapy interventions</measure>
    <time_frame>During the ICU stay until 28 days</time_frame>
    <description>Physiotherapist reported barriers to delivering the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events during physiotherapy interventions</measure>
    <time_frame>During the ICU stay until 28 days</time_frame>
    <description>Adverse events that require the intervention to be ceased for medical intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phenomenological data of the patient and family experience</measure>
    <time_frame>6 months</time_frame>
    <description>Qualitative interviews</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global function</measure>
    <time_frame>6 months</time_frame>
    <description>Global Rating of Change</description>
  </secondary_outcome>
  <enrollment type="Actual">536</enrollment>
  <condition>COVID-19</condition>
  <condition>Critical Illness</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Critically ill patients with COVID-19 admitted to an intensive care unit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. COVID-19 patients who have been admitted to ICU for &gt; 24 hours&#xD;
&#xD;
          2. Patients aged over 17 years&#xD;
&#xD;
        Persistent critical illness cohort&#xD;
&#xD;
          1. As above&#xD;
&#xD;
          2. An ICU admission of at least 10 consecutive days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous enrolment in this study in a prior ICU admission&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carol Hodgson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Monash University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Canberra Hospital</name>
      <address>
        <city>Garran</city>
        <state>Australian Capital Territory</state>
        <zip>2605</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Prince Alfred Hospital</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Concord Hospital</name>
      <address>
        <city>Concord</city>
        <state>New South Wales</state>
        <zip>2139</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital Sydney</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nepean Hospital</name>
      <address>
        <city>Kingswood</city>
        <state>New South Wales</state>
        <zip>2747</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George Hospital</name>
      <address>
        <city>Kogarah</city>
        <state>New South Wales</state>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Hunter Hospital</name>
      <address>
        <city>New Lambton Heights</city>
        <state>New South Wales</state>
        <zip>2305</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal North Shore Hospital</name>
      <address>
        <city>Saint Leonards</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Prince Charles Hospital</name>
      <address>
        <city>Chermside</city>
        <state>Queensland</state>
        <zip>4032</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane and Women's Hospital</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Redcliffe Hospital</name>
      <address>
        <city>Redcliffe</city>
        <state>Queensland</state>
        <zip>4020</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gold Coast Hospital</name>
      <address>
        <city>Southport</city>
        <state>Queensland</state>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Alexandra Hospital</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Launceston Hospital</name>
      <address>
        <city>Launceston</city>
        <state>Tasmania</state>
        <zip>7250</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Casey Hospital</name>
      <address>
        <city>Berwick</city>
        <state>Victoria</state>
        <zip>3806</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Box Hill Hospital (Eastern Health)</name>
      <address>
        <city>Box Hill</city>
        <state>Victoria</state>
        <zip>3128</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dandenong Hospital</name>
      <address>
        <city>Dandenong</city>
        <state>Victoria</state>
        <zip>3175</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital Melbourne</name>
      <address>
        <city>Fitzroy</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Footscray Hospital</name>
      <address>
        <city>Footscray</city>
        <state>Victoria</state>
        <zip>3011</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frankston Hospital</name>
      <address>
        <city>Frankston</city>
        <state>Victoria</state>
        <zip>3199</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Hospital</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabrini Health</name>
      <address>
        <city>Malvern</city>
        <state>Victoria</state>
        <zip>3144</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Australian New Zealand Intensive Care Research Centre</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Melbourne Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alfred Hospital</name>
      <address>
        <city>Prahran</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunshine Hospital</name>
      <address>
        <city>St Albans</city>
        <state>Victoria</state>
        <zip>3021</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>May 7, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>September 26, 2022</last_update_submitted>
  <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>recovery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD will be shared if approved by the steering committee and with ethical approvals.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>12 months after completion of the study for 12 months</ipd_time_frame>
    <ipd_access_criteria>Email the Chief Investigator</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04401254
org study id: COVID-Recovery V1.5 9Feb2022
nct id: NCT04401254
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients who are critically ill with COVID-19 requiring life support in an intensive care
      unit (ICU) have increased risk of morbidity and mortality. Currently the ICU community does
      not know what effect the disease, the ICU admission, physiotherapy interventions and life
      support have on their long-term quality of life and whether they can return to their
      pre-illness level of function following ICU.

      COVID-Recovery will describe the physiotherapy interventions delivered to critically ill
      patients with COVID-19. In survivors, COVID-Recovery will utilise telephone follow-up of ICU
      survivors to assess disability-free survival and quality of life at 6 months after ICU
      admission. Additionally, COVID-Recovery will identify if there are predictors of
      disability-free survival. COVID-Recovery will aim to select up to 300 patients diagnosed with
      COVID-19 from ICUs in Australia. If they survive to hospital discharge, patients will be
      invited to receive a telephone questionnaire at 6 months after the ICU admission that aims to
      assess their long-term outcomes, including physical, cognitive and emotional function,
      quality of life, and whether they have been able to return to work following ICU discharge.

      To describe the experience of critical illness in survivors of COVID-19 and their family
      members.

      To explore and describe functional recovery, respiratory system function and respiratory
      health morbidity up to 6 months after ICU admission in persistently critically ill adults
      with COVID-19
observational model: Cohort
time perspective: Prospective
measure: Disability-free survival
time frame: 6 months
description: a composite measure of WHODAS 2.0 - 12 level and hospital survival
measure: Physiotherapy intervention
time frame: During the ICU stay until 3 months
description: The physiotherapy interventions provided to patients with COVID-19 admitted to the ICU and health outcomes
measure: Health status
time frame: 6 months
description: Health related quality of life measured with EQ5D-5L score from 0 to 100
measure: Global function
time frame: 6 months
description: World Health Organization Disability Assessment Schedule 2.0 12L
measure: Cognitive function
time frame: 6 months
description: Montreal Cognitive Assessment Blind
measure: Anxiety and depression
time frame: 6 months
description: Hospital Anxiety and Depression Scale
measure: Screening for post-traumatic distress
time frame: 6 months
description: Impact of Events Scale Revised
measure: Work Status
time frame: 6 months
description: WHODAS 2.0
measure: Proportion of patients with COVID-19 who received physiotherapy in ICU
time frame: During the ICU stay until 28 days
measure: The reported barriers to delivering physiotherapy interventions
time frame: During the ICU stay until 28 days
description: Physiotherapist reported barriers to delivering the intervention
measure: Adverse events during physiotherapy interventions
time frame: During the ICU stay until 28 days
description: Adverse events that require the intervention to be ceased for medical intervention
measure: Phenomenological data of the patient and family experience
time frame: 6 months
description: Qualitative interviews
measure: Global function
time frame: 6 months
description: Global Rating of Change
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 17 Years
maximum age: N/A
healthy volunteers: No
last name: Carol Hodgson, PhD
role: Principal Investigator
affiliation: Monash University
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country: Australia
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Critical Illness
sharing ipd: Yes
ipd description: IPD will be shared if approved by the steering committee and with ethical approvals.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: 12 months after completion of the study for 12 months
ipd access criteria: Email the Chief Investigator