<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/NCT04420299</url>
  </required_header>
  <id_info>
    <org_study_id>BEMICOVID-19</org_study_id>
    <secondary_id>2020-001548-24</secondary_id>
    <nct_id>NCT04420299</nct_id>
  </id_info>
  <brief_title>Clinical Trial on the Efficacy and Safety of Bemiparin in Patients Hospitalized Because of COVID-19</brief_title>
  <official_title>A Randomized, Single-blind Study With a Parallel Control Group on the Efficacy and Safety of Bemiparin at Therapeutic Dose vs. Prophylactic Dose in Patients Hospitalized for COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación de investigación HM</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Syntax for Science, S.L</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundación de investigación HM</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 2019 coronavirus disease (Covid-19) is a new disease caused by the SARS-CoV2 virus of&#xD;
      which many things are not yet known. Among others, there is a need to define the best&#xD;
      therapeutic strategy to treat Covid-19, improving patients survival and reducing&#xD;
      complications in its management, for which many different types of treatments are being&#xD;
      tested.&#xD;
&#xD;
      The drug being tested in this clinical trial is called bemiparin. Bemiparin is a drug&#xD;
      authorized as a prevention and as a treatment for deep vein thrombosis (blood clots in one or&#xD;
      more veins, generally in the legs) and venous thromboembolism (when the clot can detach and&#xD;
      lodge in other organs such as the lungs). Covid-19 patients have been shown to be at&#xD;
      increased risk of developing clotting problems such as those described above.&#xD;
&#xD;
      In this context, this clinical trial is being carried out to find out if certain doses of&#xD;
      bemiparin can contribute to better management of the disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of funding of the non-commercial sponsor to extend recruitment and reach the target number&#xD;
    of patients specified in the protocol.&#xD;
  </why_stopped>
  <start_date type="Actual">June 4, 2020</start_date>
  <completion_date type="Actual">June 8, 2021</completion_date>
  <primary_completion_date type="Actual">June 8, 2021</primary_completion_date>
  <phase>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>randomized, single-blind, parallel control group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Subjects will be blinded to the dosing regimen (treatment dose or prophylactic dose).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients that worsen</measure>
    <time_frame>Day 10 +/- 1</time_frame>
    <description>Combined worsening variable. Presence of any of the following will be considered worseing:&#xD;
Death.&#xD;
ICU admission.&#xD;
Need for either non-invasive or invasive mechanical ventilation.&#xD;
Progression to moderate / severe respiratory distress syndrome according to objective criteria (Berlin definition).&#xD;
Venous thromboembolism (deep vein thrombosis or pulmonary embolism) or arterial (acute myocardial infarction or stroke).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality from any cause at day 28</measure>
    <time_frame>Day 28</time_frame>
    <description>Mortality from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects that requires admission to the ICU</measure>
    <time_frame>From study start to day 28</time_frame>
    <description>Proportion of subjects that requires admission to the ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects requiring non-invasive mechanical ventilation</measure>
    <time_frame>From study start to day 28</time_frame>
    <description>Proportion of subjects requiring non-invasive mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects requiring invasive mechanical ventilation.</measure>
    <time_frame>From study start to day 28</time_frame>
    <description>Proportion of subjects requiring invasive mechanical ventilation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with some organ failure</measure>
    <time_frame>From study start to day 28</time_frame>
    <description>Proportion of subjects with some organ failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who have modified their oxygen therapy requirements between treatment assessment visit and baseline</measure>
    <time_frame>From study start to day 28</time_frame>
    <description>Proportion of patients who have modified their oxygen therapy requirements between treatment assessment visit and baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with pathological angioTAC</measure>
    <time_frame>At day 10 +/-1</time_frame>
    <description>Proportion of subjects with pathological angioTAC at day 10 +/-1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with improvement in chest radiography</measure>
    <time_frame>At day 10 +/-1</time_frame>
    <description>Proportion of subjects with improvement in chest radiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion and median hospital discharge between patients in both groups.</measure>
    <time_frame>From study start to day 28</time_frame>
    <description>Proportion and median hospital discharge between patients in both groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Titration score</measure>
    <time_frame>From study start to day 28</time_frame>
    <description>Titration score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ferritin score</measure>
    <time_frame>From study start to day 28</time_frame>
    <description>Ferritin score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>D-dimer modification score</measure>
    <time_frame>From study start to day 28</time_frame>
    <description>D-dimer modification score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events (total and serious).</measure>
    <time_frame>From study start to day 28</time_frame>
    <description>Adverse events (total and serious)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Related adverse events (total and serious).</measure>
    <time_frame>From study start to day 28</time_frame>
    <description>Related adverse events (total and serious).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically relevant major and non major hemorrhages.</measure>
    <time_frame>From study start to day 28</time_frame>
    <description>Clinically relevant major and non major hemorrhages.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Covid-19</condition>
  <arm_group>
    <arm_group_label>Experimental - therapeutic bemiparin dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sub-cutaneous dose of bemiparin at therapeutic dose for 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control - prophylactic bemiparin dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sub-cutaneous dose of bemiparin at prophilactic dose for 10 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bemiparin</intervention_name>
    <description>Bemiparin at therapeutic dose for 10 days</description>
    <arm_group_label>Experimental - therapeutic bemiparin dose</arm_group_label>
    <other_name>Therapeutic dose</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bemiparin</intervention_name>
    <description>Bemiparin at prophylactic dose for 10 days</description>
    <arm_group_label>Control - prophylactic bemiparin dose</arm_group_label>
    <other_name>Prophylactic dose</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Informed consent.&#xD;
&#xD;
          2. Age of 18 years or more.&#xD;
&#xD;
          3. Patient with suspected COVID-19 and who meets hospitalization criteria.&#xD;
&#xD;
          4. D-dimer&gt; 500 ng / ml.&#xD;
&#xD;
          5. Clinical characteristics highly compatible with SARS-CoV-2 infection and confirmation&#xD;
             by RT-qPCR at baseline or in the second sample in case of a first negative test and&#xD;
             clinical suspicion remains.&#xD;
&#xD;
          6. Patient admitted to hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. ICU admission criteria.&#xD;
&#xD;
          2. Need for invasive or not invasive mechanical ventilation&#xD;
&#xD;
          3. Pregnancy.&#xD;
&#xD;
          4. Creatine clearance &lt;30 ml / min (Cockroft-Gault).&#xD;
&#xD;
          5. Severe liver or pancreatic function disorder.&#xD;
&#xD;
          6. Acute bacterial endocarditis and slow endocarditis.&#xD;
&#xD;
          7. Patient previously anticoagulated (although it is allowed to have received heparin at&#xD;
             a previous low dose without time limit).&#xD;
&#xD;
          8. Patient with high hemorrhagic risk due to previous medical-surgical history.&#xD;
&#xD;
          9. Severe thrombocytopenia (&lt;80,000 platelets/ mm3) or known history of heparin-induced&#xD;
             thrombocytopenia.&#xD;
&#xD;
         10. Active bleeding or increased risk of bleeding from haemostasis disorders or from&#xD;
             organic lesions that are liable to bleed (eg, active peptic ulcer, hemorrhagic stroke,&#xD;
             aneurysms, or brain malignancies).&#xD;
&#xD;
         11. Damage or surgical interventions in the central nervous system, eyes and ears that&#xD;
             have taken place in the last 2 months.&#xD;
&#xD;
         12. Simultaneous participation in another clinical trial that could have a conflictive&#xD;
             interaction with what it is intended to evaluate.&#xD;
&#xD;
         13. Any situation that in the opinion of the researcher could interfere with the treatment&#xD;
             or with the evolution of the patient.&#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>Antonio Cubillo, MD</last_name>
    <role>Study Director</role>
    <affiliation>Director</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario HM Montepríncipe</name>
      <address>
        <city>Boadilla Del Monte</city>
        <state>Madrid</state>
        <zip>28660</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario HM Puerta del Sur</name>
      <address>
        <city>Móstoles</city>
        <state>Madrid</state>
        <zip>28938</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 3, 2022</last_update_submitted>
  <last_update_submitted_qc>June 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>covid-19</keyword>
  <keyword>immunothrombosis</keyword>
  <keyword>d-dimer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heparin, Low-Molecular-Weight</mesh_term>
    <mesh_term>Bemiparin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04420299
org study id: BEMICOVID-19
secondary id: 2020-001548-24
nct id: NCT04420299
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The 2019 coronavirus disease (Covid-19) is a new disease caused by the SARS-CoV2 virus of
      which many things are not yet known. Among others, there is a need to define the best
      therapeutic strategy to treat Covid-19, improving patients survival and reducing
      complications in its management, for which many different types of treatments are being
      tested.

      The drug being tested in this clinical trial is called bemiparin. Bemiparin is a drug
      authorized as a prevention and as a treatment for deep vein thrombosis (blood clots in one or
      more veins, generally in the legs) and venous thromboembolism (when the clot can detach and
      lodge in other organs such as the lungs). Covid-19 patients have been shown to be at
      increased risk of developing clotting problems such as those described above.

      In this context, this clinical trial is being carried out to find out if certain doses of
      bemiparin can contribute to better management of the disease.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized, single-blind, parallel control group
primary purpose: Treatment
masking: Single (Participant)
masking description: Subjects will be blinded to the dosing regimen (treatment dose or prophylactic dose).
measure: Proportion of patients that worsen
time frame: Day 10 +/- 1
description: Combined worsening variable. Presence of any of the following will be considered worseing:
Death.
ICU admission.
Need for either non-invasive or invasive mechanical ventilation.
Progression to moderate / severe respiratory distress syndrome according to objective criteria (Berlin definition).
Venous thromboembolism (deep vein thrombosis or pulmonary embolism) or arterial (acute myocardial infarction or stroke).
measure: Mortality from any cause at day 28
time frame: Day 28
description: Mortality from any cause
measure: Proportion of subjects that requires admission to the ICU
time frame: From study start to day 28
description: Proportion of subjects that requires admission to the ICU
measure: Proportion of subjects requiring non-invasive mechanical ventilation
time frame: From study start to day 28
description: Proportion of subjects requiring non-invasive mechanical ventilation
measure: Proportion of subjects requiring invasive mechanical ventilation.
time frame: From study start to day 28
description: Proportion of subjects requiring invasive mechanical ventilation.
measure: Proportion of subjects with some organ failure
time frame: From study start to day 28
description: Proportion of subjects with some organ failure
measure: Proportion of patients who have modified their oxygen therapy requirements between treatment assessment visit and baseline
time frame: From study start to day 28
description: Proportion of patients who have modified their oxygen therapy requirements between treatment assessment visit and baseline
measure: Proportion of subjects with pathological angioTAC
time frame: At day 10 +/-1
description: Proportion of subjects with pathological angioTAC at day 10 +/-1
measure: Proportion of subjects with improvement in chest radiography
time frame: At day 10 +/-1
description: Proportion of subjects with improvement in chest radiography
measure: Proportion and median hospital discharge between patients in both groups.
time frame: From study start to day 28
description: Proportion and median hospital discharge between patients in both groups.
measure: Titration score
time frame: From study start to day 28
description: Titration score
measure: Ferritin score
time frame: From study start to day 28
description: Ferritin score
measure: D-dimer modification score
time frame: From study start to day 28
description: D-dimer modification score
measure: Adverse events (total and serious).
time frame: From study start to day 28
description: Adverse events (total and serious)
measure: Related adverse events (total and serious).
time frame: From study start to day 28
description: Related adverse events (total and serious).
measure: Clinically relevant major and non major hemorrhages.
time frame: From study start to day 28
description: Clinically relevant major and non major hemorrhages.
arm group label: Experimental - therapeutic bemiparin dose
arm group type: Experimental
description: Sub-cutaneous dose of bemiparin at therapeutic dose for 10 days
arm group label: Control - prophylactic bemiparin dose
arm group type: Experimental
description: Sub-cutaneous dose of bemiparin at prophilactic dose for 10 days
intervention type: Drug
intervention name: Bemiparin
description: Bemiparin at therapeutic dose for 10 days
arm group label: Experimental - therapeutic bemiparin dose
other name: Therapeutic dose
intervention type: Drug
intervention name: Bemiparin
description: Bemiparin at prophylactic dose for 10 days
arm group label: Control - prophylactic bemiparin dose
other name: Prophylactic dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antonio Cubillo, MD
role: Study Director
affiliation: Director
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Heparin, Low-Molecular-Weight
mesh term: Bemiparin
sharing ipd: No