<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/NCT04422509</url>
  </required_header>
  <id_info>
    <org_study_id>UMCN-AKF20.04</org_study_id>
    <nct_id>NCT04422509</nct_id>
  </id_info>
  <brief_title>Lanadelumab for Treatment of COVID-19 Disease</brief_title>
  <acronym>COVID_LAN</acronym>
  <official_title>Lanadelumab for Treatment of COVID-19 Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Radboud University Medical Center</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      So far little is very few drugs have demonstrated positive results for treatment of COVID19.&#xD;
&#xD;
      Recently the researchers have shown that the use of icatibant in COVID-19 results in a potent&#xD;
      decrease in oxygen use. Yet the effect of the three dosages as according to the label dose&#xD;
      was insufficient to maintain the clinical improvement in a small group of patients. The&#xD;
      researchers argue that with the use of lanadelumab a more lasting effect can be reached due&#xD;
      to its longer half life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2020</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">February 25, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>controls will get standard of care and historical controls will be matched to the patients included</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>oxygen</measure>
    <time_frame>2 weeks</time_frame>
    <description>oxygen use in L/min</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>2 weeks</time_frame>
    <description>adverse events after lanadelumab administration</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>lanadelumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 Patients will receive an intravenous dose of 300 mg lanadelumab on day 1, followed by a second dose of lanadelumab 300mg iv on day 4 (if needed).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>controls</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>20 patients will received standard of care In additiona, for every index patient we will match one historical controls. Controls will be matched based on age, bodyweight and gender.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>lanadelumab</intervention_name>
    <description>single dose, or two doses administered iv</description>
    <arm_group_label>lanadelumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>regular care</intervention_name>
    <description>no lanadelumab administration, treated according to regular care</description>
    <arm_group_label>controls</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is SARS-COV2 positive (PCR)&#xD;
&#xD;
          -  Without oxygen a saturation below 90%&#xD;
&#xD;
          -  At least 3L/min oxygen dependent&#xD;
&#xD;
          -  Patient is 16 years and older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has previously participated in this study&#xD;
&#xD;
          -  Acute myocardial or cerebral ischemic event at time of enrolment&#xD;
&#xD;
          -  Receiving ACE or ARB inhibitor or comparable drugs that is specified as an&#xD;
             intervention in this domain as a usual medication prior to this hospitalization will&#xD;
             exclude a patient from receiving that agent&#xD;
&#xD;
          -  A baseline alanine aminotransferase or an aspartate aminotransferase that is more than&#xD;
             five times the upper limit of normal&#xD;
&#xD;
          -  Patient is known hypersensitive to full human monoclonal antibodies&#xD;
&#xD;
          -  Patient is pregnant or breast feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Amsterdam UMC</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rijnstate hospital</name>
      <address>
        <city>Arnhem</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radboudumc</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMC Utrecht</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>July 11, 2021</last_update_submitted>
  <last_update_submitted_qc>July 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 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>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>this has not yet been decided</ipd_description>
  </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/NCT04422509
org study id: UMCN-AKF20.04
nct id: NCT04422509
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
So far little is very few drugs have demonstrated positive results for treatment of COVID19.

      Recently the researchers have shown that the use of icatibant in COVID-19 results in a potent
      decrease in oxygen use. Yet the effect of the three dosages as according to the label dose
      was insufficient to maintain the clinical improvement in a small group of patients. The
      researchers argue that with the use of lanadelumab a more lasting effect can be reached due
      to its longer half life.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: controls will get standard of care and historical controls will be matched to the patients included
primary purpose: Treatment
masking: None (Open Label)
measure: oxygen
time frame: 2 weeks
description: oxygen use in L/min
measure: adverse events
time frame: 2 weeks
description: adverse events after lanadelumab administration
arm group label: lanadelumab
arm group type: Experimental
description: 20 Patients will receive an intravenous dose of 300 mg lanadelumab on day 1, followed by a second dose of lanadelumab 300mg iv on day 4 (if needed).
arm group label: controls
arm group type: Other
description: 20 patients will received standard of care In additiona, for every index patient we will match one historical controls. Controls will be matched based on age, bodyweight and gender.
intervention type: Biological
intervention name: lanadelumab
description: single dose, or two doses administered iv
arm group label: lanadelumab
intervention type: Other
intervention name: regular care
description: no lanadelumab administration, treated according to regular care
arm group label: controls
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided
ipd description: this has not yet been decided