<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/NCT04443257</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0340</org_study_id>
    <nct_id>NCT04443257</nct_id>
  </id_info>
  <brief_title>REassessement After Hospitalization for Sars-COV-2 disordER</brief_title>
  <acronym>REHCOVER</acronym>
  <official_title>REassessement After Hospitalization for Sars-COV-2 Infection : Standardized Assessment of Sequelae and Comorbidities 3 to 6 Months After Hospitalization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Currently, the sequelae and short-term medical and psychological impact of the sars-cov-2&#xD;
      infection (&quot;CoVID-19&quot;) remain poorly described. The clinical and functional sequelae that may&#xD;
      persist after acute sars-cov-2 (&quot;CoVID-19&quot;) infection are essential to explore, in order to&#xD;
      ensure the best possible follow-up of patients after discharge from hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since sars-cov-2 (&quot;CoVID-19&quot;) is a newly defined infection, its sequelae and short-term&#xD;
      medical and psychological impact remain poorly described.The clinical and functional sequelae&#xD;
      that may persist after acute sars-cov-2 (&quot;CoVID-19&quot;) infection are essential to explore, in&#xD;
      order to ensure the best possible follow-up of patients after discharge from hospital.&#xD;
&#xD;
      Indeed, some patients may develop chronic respiratory failure, pulmonary fibrosis, or other&#xD;
      comorbidities including cardiovascular or metabolic diseases. The psychological impact is&#xD;
      also essential to assess. The sequelae and comorbidities of patients could also vary&#xD;
      depending on the severity of the initial acute involvement.&#xD;
&#xD;
      Investigators propose to explore the sequelae of patients who have been hospitalized for&#xD;
      acute sars-cov-2 infection, between 3 to 6 months after discharge from hospital, by&#xD;
      characterizing the incidence of chronic respiratory failure and fibrosis, as well as of&#xD;
      various comorbidities such as cardiovascular, metabolic, and psychological diseases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    not enough inclusions&#xD;
  </why_stopped>
  <start_date type="Actual">July 8, 2020</start_date>
  <completion_date type="Actual">February 18, 2022</completion_date>
  <primary_completion_date type="Actual">February 18, 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>Development or worsening of a ventilatory disorder and/or chronic respiratory failure assessed by spirometry</measure>
    <time_frame>3 to 6 months after Sars coV 2 infection</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of dyspnea</measure>
    <time_frame>3 to 6 months after Sars coV 2 infection</time_frame>
    <description>assessed by 0-10 Borg scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of pulmonary lesions as assessed by lung CT scan</measure>
    <time_frame>3 to 6 months after Sars coV 2 infection</time_frame>
    <description>assessed by lung CT scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of pulmonary fibrosis as assessed by lung CT scan</measure>
    <time_frame>3 to 6 months after Sars coV 2 infection</time_frame>
    <description>assessed by lung CT scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence or worsening of cardiovascular diseases</measure>
    <time_frame>3 to 6 months after Sars coV 2 infection</time_frame>
    <description>assessed by incidence of cardiovascular events, venous thromboembolism, and transthoracic echocardiogram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence or worsening of renal disease</measure>
    <time_frame>3 to 6 months after Sars coV 2 infection</time_frame>
    <description>renal function and urinary parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence or worsening of liver disease</measure>
    <time_frame>3 to 6 months after Sars coV 2 infection</time_frame>
    <description>hepatic blood parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence or worsening of psychological pathology : anxiety</measure>
    <time_frame>3 to 6 months after Sars coV 2 infection</time_frame>
    <description>assessed by validated scale: Generalized Anxiety Disorder-7 (GAD7)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence or worsening of psychological pathology: depression</measure>
    <time_frame>3 to 6 months after Sars coV 2 infection</time_frame>
    <description>assessed by validated scales: Patient Health Questionnaire-9 (PHQ9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence or worsening of psychological pathology: post-traumatic stress</measure>
    <time_frame>3 to 6 months after Sars coV 2 infection</time_frame>
    <description>assessed by validated scale : Post-traumatic Checklist for DSM-5 (PCL-5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence or worsening of psychological pathology: insomnia</measure>
    <time_frame>3 to 6 months after Sars coV 2 infection</time_frame>
    <description>assessed by validated scale : insomnia severity index (ISI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the health-related quality of life</measure>
    <time_frame>3 to 6 months after Sars coV 2 infection</time_frame>
    <description>assessed by validated scale (EQ-5D-L questionnaire)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the fatigue</measure>
    <time_frame>3 to 6 months after Sars coV 2 infection</time_frame>
    <description>assessed by the fatigue severity sale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the socioeconomic deprivation</measure>
    <time_frame>3 to 6 months after Sars coV 2 infection</time_frame>
    <description>assessed by the Evaluation of Deprivation and Inequalities in Health Examination (EPICES) scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>development or worsening of metabolic disorders: diabetes, thyroid diseases, dyslipidemia, adrenal disorders, malnutrition</measure>
    <time_frame>3 to 6 months after Sars coV 2 infection</time_frame>
    <description>assessed by blood glucose level, HbA1C, lipid blood tests, TSH, T3, T4, antithyroperoxydase antibodies, cortisol, ACTH, renin, aldosteron, albumin level, vitamin D level, iron status, weight changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of auto-immune disorders</measure>
    <time_frame>3 to 6 months after Sars coV 2 infection</time_frame>
    <description>assessed by lupus anticoagulant, anti-cardiolipin, anti-β2-glycoprotein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the evolution of the humoral anti-SARS-CoV-2 immunization profile</measure>
    <time_frame>3 to 6 months after Sars coV 2 infection</time_frame>
    <description>Presence and levels of anti-SARS-CoV-2 antibodies of IgG, IgA and IgM isotypes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' self-reported level of physical activity</measure>
    <time_frame>3 to 6 months after Sars coV 2 infection</time_frame>
    <description>assessed by the International Physical Activity Questionnaire (IPAQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of risk factors associated with sequelae or comorbidities</measure>
    <time_frame>3 to 6 months after Sars coV 2 infection</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">119</enrollment>
  <condition>Sars-CoV2</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>assessment of the sequelae after hospitalization for Sars-COV-2</intervention_name>
    <description>the incidence of chronic respiratory failure and fibrosis, as well as of comorbidities including cardiovascular, metabolic, renal, hepatic, neurological, and psychological diseases</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult who was hospitalized within 3 to 6 months for a sars-CoV infection at Montpellier&#xD;
        University Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient who was hospitalized within 3 to 6 months for a sars-CoV infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of signed informed consent&#xD;
&#xD;
          -  pregnancy or breastfeeding&#xD;
&#xD;
          -  patient under guardianship or curatorship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University hospital of Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Berger M, Daubin D, Charriot J, Klouche K, Le Moing V, Morquin D, Halimi L, Jaussent A, Taourel P, Hayot M, Cristol JP, Nagot N, Fesler P, Roubille C. Mid-Term Sequelae of Surviving Patients Hospitalized in Intensive Care Unit for COVID-19 Infection: The REHCOVER Study. J Clin Med. 2023 Jan 28;12(3):1000. doi: 10.3390/jcm12031000.</citation>
    <PMID>36769648</PMID>
  </results_reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>February 16, 2023</last_update_submitted>
  <last_update_submitted_qc>February 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>comorbidities</keyword>
  <keyword>Sars-CoV2</keyword>
  <keyword>sequelae</keyword>
  <keyword>patient outcome assessment</keyword>
  <keyword>Covid19</keyword>
  <keyword>quality of life</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be made available upon a reasonable request</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>12 months after the main publication</ipd_time_frame>
    <ipd_access_criteria>Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and institutional review board (IRB) review. Dataset will be shared after careful examination by the study board of investigators.</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/NCT04443257
org study id: RECHMPL20_0340
nct id: NCT04443257
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Currently, the sequelae and short-term medical and psychological impact of the sars-cov-2
      infection ("CoVID-19") remain poorly described. The clinical and functional sequelae that may
      persist after acute sars-cov-2 ("CoVID-19") infection are essential to explore, in order to
      ensure the best possible follow-up of patients after discharge from hospital.
Since sars-cov-2 ("CoVID-19") is a newly defined infection, its sequelae and short-term
      medical and psychological impact remain poorly described.The clinical and functional sequelae
      that may persist after acute sars-cov-2 ("CoVID-19") infection are essential to explore, in
      order to ensure the best possible follow-up of patients after discharge from hospital.

      Indeed, some patients may develop chronic respiratory failure, pulmonary fibrosis, or other
      comorbidities including cardiovascular or metabolic diseases. The psychological impact is
      also essential to assess. The sequelae and comorbidities of patients could also vary
      depending on the severity of the initial acute involvement.

      Investigators propose to explore the sequelae of patients who have been hospitalized for
      acute sars-cov-2 infection, between 3 to 6 months after discharge from hospital, by
      characterizing the incidence of chronic respiratory failure and fibrosis, as well as of
      various comorbidities such as cardiovascular, metabolic, and psychological diseases.
observational model: Cohort
time perspective: Prospective
measure: Development or worsening of a ventilatory disorder and/or chronic respiratory failure assessed by spirometry
time frame: 3 to 6 months after Sars coV 2 infection
measure: Assessment of dyspnea
time frame: 3 to 6 months after Sars coV 2 infection
description: assessed by 0-10 Borg scale
measure: Description of pulmonary lesions as assessed by lung CT scan
time frame: 3 to 6 months after Sars coV 2 infection
description: assessed by lung CT scan
measure: Development of pulmonary fibrosis as assessed by lung CT scan
time frame: 3 to 6 months after Sars coV 2 infection
description: assessed by lung CT scan
measure: Incidence or worsening of cardiovascular diseases
time frame: 3 to 6 months after Sars coV 2 infection
description: assessed by incidence of cardiovascular events, venous thromboembolism, and transthoracic echocardiogram
measure: Incidence or worsening of renal disease
time frame: 3 to 6 months after Sars coV 2 infection
description: renal function and urinary parameters
measure: Incidence or worsening of liver disease
time frame: 3 to 6 months after Sars coV 2 infection
description: hepatic blood parameters
measure: Incidence or worsening of psychological pathology : anxiety
time frame: 3 to 6 months after Sars coV 2 infection
description: assessed by validated scale: Generalized Anxiety Disorder-7 (GAD7)
measure: Incidence or worsening of psychological pathology: depression
time frame: 3 to 6 months after Sars coV 2 infection
description: assessed by validated scales: Patient Health Questionnaire-9 (PHQ9)
measure: Incidence or worsening of psychological pathology: post-traumatic stress
time frame: 3 to 6 months after Sars coV 2 infection
description: assessed by validated scale : Post-traumatic Checklist for DSM-5 (PCL-5)
measure: Incidence or worsening of psychological pathology: insomnia
time frame: 3 to 6 months after Sars coV 2 infection
description: assessed by validated scale : insomnia severity index (ISI)
measure: Assessment of the health-related quality of life
time frame: 3 to 6 months after Sars coV 2 infection
description: assessed by validated scale (EQ-5D-L questionnaire)
measure: Assessment of the fatigue
time frame: 3 to 6 months after Sars coV 2 infection
description: assessed by the fatigue severity sale
measure: Assessment of the socioeconomic deprivation
time frame: 3 to 6 months after Sars coV 2 infection
description: assessed by the Evaluation of Deprivation and Inequalities in Health Examination (EPICES) scale
measure: development or worsening of metabolic disorders: diabetes, thyroid diseases, dyslipidemia, adrenal disorders, malnutrition
time frame: 3 to 6 months after Sars coV 2 infection
description: assessed by blood glucose level, HbA1C, lipid blood tests, TSH, T3, T4, antithyroperoxydase antibodies, cortisol, ACTH, renin, aldosteron, albumin level, vitamin D level, iron status, weight changes
measure: Development of auto-immune disorders
time frame: 3 to 6 months after Sars coV 2 infection
description: assessed by lupus anticoagulant, anti-cardiolipin, anti-β2-glycoprotein
measure: Assessment of the evolution of the humoral anti-SARS-CoV-2 immunization profile
time frame: 3 to 6 months after Sars coV 2 infection
description: Presence and levels of anti-SARS-CoV-2 antibodies of IgG, IgA and IgM isotypes
measure: Patients' self-reported level of physical activity
time frame: 3 to 6 months after Sars coV 2 infection
description: assessed by the International Physical Activity Questionnaire (IPAQ)
measure: Determination of risk factors associated with sequelae or comorbidities
time frame: 3 to 6 months after Sars coV 2 infection
intervention type: Other
intervention name: assessment of the sequelae after hospitalization for Sars-COV-2
description: the incidence of chronic respiratory failure and fibrosis, as well as of comorbidities including cardiovascular, metabolic, renal, hepatic, neurological, and psychological diseases
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
citation: Berger M, Daubin D, Charriot J, Klouche K, Le Moing V, Morquin D, Halimi L, Jaussent A, Taourel P, Hayot M, Cristol JP, Nagot N, Fesler P, Roubille C. Mid-Term Sequelae of Surviving Patients Hospitalized in Intensive Care Unit for COVID-19 Infection: The REHCOVER Study. J Clin Med. 2023 Jan 28;12(3):1000. doi: 10.3390/jcm12031000.
PMID: 36769648
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Data will be made available upon a reasonable request
ipd info type: Study Protocol
ipd time frame: 12 months after the main publication
ipd access criteria: Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and institutional review board (IRB) review. Dataset will be shared after careful examination by the study board of investigators.