<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/NCT04459364</url>
  </required_header>
  <id_info>
    <org_study_id>20200422PA</org_study_id>
    <nct_id>NCT04459364</nct_id>
  </id_info>
  <brief_title>The Prevalence of Pulmonary Hypertension in Patients With COVID-19.</brief_title>
  <official_title>The Prevalence of Pulmonary Hypertension, With or Without Right Ventricular Loading, in Patients With COVID-19 Who Are Being Treated With a Respirator in the Intensive Care Unit.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Attgeno AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Attgeno AB</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>
      The virus infection Covid-19 fills our hospitals and intensive care departments in a very&#xD;
      unique way and there is a lack of essential insight into the pathophysiology of the disease.&#xD;
      As a result, very specific treatment options are missing. The US Medicines Agency (FDA) has&#xD;
      in the last days given a general license for treatment with inhaled nitric oxide (iNO).&#xD;
      Inhaled NO in Sweden (and Europe) is approved for the indication of pulmonary hypertension in&#xD;
      adults.&#xD;
&#xD;
      However, no one has yet described the occurrence of pulmonary hypertension, with or without&#xD;
      right ventricular loading, in the Covid-19 patients who become so seriously ill that they&#xD;
      need to be treated at an IVA ward. Knowledge of this is, of course, a prerequisite for&#xD;
      determining the need for pulmonary artery catheterization (PA catheter, Swan-Ganz catheter)&#xD;
      and also to better understand whether iNO treatment or other forms of lung selective&#xD;
      vasodilation therapy may be of benefit to this patient group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Demographics and data from study variables will be documented in paper CRFs at the&#xD;
      investigational site.&#xD;
&#xD;
        -  Demography&#xD;
&#xD;
           o Age, sex&#xD;
&#xD;
        -  Covid-19 related variables&#xD;
&#xD;
           o COVID-19 diagnosis&#xD;
&#xD;
        -  Concomitant diseases&#xD;
&#xD;
           o Comorbidity, previous and present&#xD;
&#xD;
        -  Cardiovascular risk factors&#xD;
&#xD;
           o Smoking&#xD;
&#xD;
        -  Laboratory values&#xD;
&#xD;
        -  On-site measurements o Evaluation with echocardiography&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">July 15, 2020</completion_date>
  <primary_completion_date type="Actual">July 7, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>21 Days</target_duration>
  <primary_outcome>
    <measure>Prevalence</measure>
    <time_frame>Day 1</time_frame>
    <description>To determine the prevalence of pulmonary hypertension and right ventricular load in patients with COVID-19 treated in intensive care unit evaluated by routine echocardiography.</description>
  </primary_outcome>
  <enrollment type="Actual">67</enrollment>
  <condition>Hypertension, Pulmonary</condition>
  <condition>Right Ventricular Overload</condition>
  <condition>COVID</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This is a non-interventional retrospective study to be performed in an intensive care unit&#xD;
        in Sweden. The study will include 80 Covid-19 patients who had been examined with&#xD;
        echocardiography. Data will be collected through chart review.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women at least 18 years of age&#xD;
&#xD;
          -  Diagnosed with COVID-19 and is treated at an intensive care unit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Responsible investigator considers that co-morbidity is so pronounced that it does not&#xD;
             allow reasonable interpretation of data.&#xD;
&#xD;
          -  Missing verified diagnosis of COVID-19&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Per-Arne Lönnqvist, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>17176</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>January 8, 2021</last_update_submitted>
  <last_update_submitted_qc>January 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2021</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>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participants data that underlie the results reported in this article will be shared, after deidentification (text, figures and appendices)</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Beginning 3 months and ending 5 years following article publication.</ipd_time_frame>
    <ipd_access_criteria>Researchers who provide a methodologically sound proposal and to achieve aims in the proposal. Proposals should be directed to per-arne.lonnqvist@ki.se. To gain access, data requestors will need to sign a data access agreement.</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/NCT04459364
org study id: 20200422PA
nct id: NCT04459364
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The virus infection Covid-19 fills our hospitals and intensive care departments in a very
      unique way and there is a lack of essential insight into the pathophysiology of the disease.
      As a result, very specific treatment options are missing. The US Medicines Agency (FDA) has
      in the last days given a general license for treatment with inhaled nitric oxide (iNO).
      Inhaled NO in Sweden (and Europe) is approved for the indication of pulmonary hypertension in
      adults.

      However, no one has yet described the occurrence of pulmonary hypertension, with or without
      right ventricular loading, in the Covid-19 patients who become so seriously ill that they
      need to be treated at an IVA ward. Knowledge of this is, of course, a prerequisite for
      determining the need for pulmonary artery catheterization (PA catheter, Swan-Ganz catheter)
      and also to better understand whether iNO treatment or other forms of lung selective
      vasodilation therapy may be of benefit to this patient group.
Demographics and data from study variables will be documented in paper CRFs at the
      investigational site.

        -  Demography

           o Age, sex

        -  Covid-19 related variables

           o COVID-19 diagnosis

        -  Concomitant diseases

           o Comorbidity, previous and present

        -  Cardiovascular risk factors

           o Smoking

        -  Laboratory values

        -  On-site measurements o Evaluation with echocardiography
observational model: Cohort
time perspective: Other
measure: Prevalence
time frame: Day 1
description: To determine the prevalence of pulmonary hypertension and right ventricular load in patients with COVID-19 treated in intensive care unit evaluated by routine echocardiography.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Per-Arne Lönnqvist, Professor
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Hypertension, Pulmonary
mesh term: Hypertension
sharing ipd: Yes
ipd description: Individual participants data that underlie the results reported in this article will be shared, after deidentification (text, figures and appendices)
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: Beginning 3 months and ending 5 years following article publication.
ipd access criteria: Researchers who provide a methodologically sound proposal and to achieve aims in the proposal. Proposals should be directed to per-arne.lonnqvist@ki.se. To gain access, data requestors will need to sign a data access agreement.