<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/NCT04416334</url>
  </required_header>
  <id_info>
    <org_study_id>COLCHICOVID</org_study_id>
    <nct_id>NCT04416334</nct_id>
  </id_info>
  <brief_title>PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS</brief_title>
  <acronym>COLCHI-COVID</acronym>
  <official_title>PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS SARS-CoV2 (COVID-19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Investigación Marqués de Valdecilla</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gerencia de atención primaria área 1</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gerencia de atención primaria área 2</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gerencia Atencion Primaria Area 3</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gerencia de atención primaria área 4</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto de Investigación Marqués de Valdecilla</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a phase 3 clinical trial, randomized, single-center, opened, controlled, to evaluate&#xD;
      efficacy and safety of early administration of colchicines in patients older than 60 years,&#xD;
      with high risk of pulmonary complications due to coronavirus SARS-CoV2 (COVID-19). An&#xD;
      approximately number of 954 subjects meeting all inclusion and none exclusion criteria will&#xD;
      be randomized either to receive colchicines or symptomatic treatment with paracetamol during&#xD;
      21 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of the study is to determine whether short term course of colchicines&#xD;
      reduces number of deaths due to COVID-19 and severe complications due to the virus in elderly&#xD;
      patients with comorbidities.&#xD;
&#xD;
      The secondary objective is to determine the safety of colchicines in this patient population.&#xD;
&#xD;
      Approximately 954 subjects who meet all inclusion criteria and none exclusion criteria will&#xD;
      be randomized either to receive colchicines or symptomatic treatment (2:1 allocation ratio)&#xD;
      during 21 days. Follow-up assessments will occur every 48 hours and always at day 10, 21 and&#xD;
      61 following randomization for evaluation of the occurrence of any trial endpoints or other&#xD;
      adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 19, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 25, 2021</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants who die due to COVID-19 infection</measure>
    <time_frame>21 days post-randomization</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants who require hospitalization due to COVID-19 infection</measure>
    <time_frame>21 days post-randomization</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>A confirmed diagnosis from COVID-19 infection (by positive PCR test) will be mandatory .</measure>
    <time_frame>48 hours</time_frame>
    <description>not delayed more than 48 hours from initial symptoms</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">954</enrollment>
  <condition>SARS-CoV-2 Infection (COVID-19)</condition>
  <arm_group>
    <arm_group_label>Colchicine plus symptomatic treatment (paracetamol).</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will receive study medication colchicines 0.5 mg orally (PO) twice daily for the first 3 days and then once daily for the last 18 days. If a dose is missed, it should not be replaced.&#xD;
All patients should also receive best symptomatic treatment (mainly paracetamol), based on clinical practice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Symptomatic treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Colchicine plus symptomatic treatment (paracetamol)</intervention_name>
    <description>Colchicine plus symptomatic treatment (paracetamol).</description>
    <arm_group_label>Colchicine plus symptomatic treatment (paracetamol).</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations)</intervention_name>
    <description>Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations).</description>
    <arm_group_label>Symptomatic treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients of both sexes who are at least 60 years old.&#xD;
&#xD;
          2. Diagnosis of COVID-19 infection in the last 72 hours and confirmed by PCR&#xD;
&#xD;
          3. Patient in outpatient follow-up (not hospitalized or under consideration) or&#xD;
             institutionalized in senior centers/residences&#xD;
&#xD;
          4. The patient must possess at least two of the following high-risk criteria&#xD;
&#xD;
               1. 60 years of age or older AND&#xD;
&#xD;
               2. Any of the following: Diabetes mellitus, high blood pressure, known pulmonary&#xD;
                  disease (including asthma or chronic obstructive pulmonary disease), known heart&#xD;
                  failure, known coronary disease, bicytopenia, pancytopenia, or the existence of&#xD;
                  simultaneous neutrophilia and lymphopenia&#xD;
&#xD;
          5. The patient must be able and willing to comply with the requirements of this study&#xD;
             protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hospitalized patient or under immediate consideration of doing so&#xD;
&#xD;
          2. Patient taking colchicine for other indications&#xD;
&#xD;
          3. Patient with history of allergic reaction or sensitivity to colchicine&#xD;
&#xD;
          4. Patient with inflammatory bowel disease, gastric ulcer, chronic diarrhea or&#xD;
             malabsorption&#xD;
&#xD;
          5. Patient with pre-existing progressive neuromuscular disease&#xD;
&#xD;
          6. Patient with kidney damage and estimated glomerular filtrate rate &lt;30 ml/m at 1732&#xD;
&#xD;
          7. Patient undergoing chemotherapy for cancer, including haematological malignancies.&#xD;
&#xD;
          8. Patients being treated with CYP3A4 and/or glycoprotein inhibitor drugs&#xD;
&#xD;
          9. Immunosuppressive treatment&#xD;
&#xD;
         10. History of cirrhosis, chronic active hepatitis, severe chronic disease defined by GOT&#xD;
             or GPT values exceeding 3 times the upper limit of normal.&#xD;
&#xD;
         11. If the investigator considers it, for any reason, to be an inadequate candidate.&#xD;
&#xD;
         12. Patient and/or legal representative will not have signed the informed consent form.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Carlos Richard</last_name>
    <phone>942203333</phone>
    <email>carlos.richard@scsalud.es</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mar García, PhD</last_name>
    <phone>942203333</phone>
    <email>mmar.garcia@scsalud.es</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Atención primaria (Área 2)</name>
      <address>
        <city>Laredo</city>
        <state>Cantabria</state>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juan Carlos Lopez Caro</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gerencia de atención primaria (Área 3)</name>
      <address>
        <city>Reinosa</city>
        <state>Cantabria</state>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jonatan Diaz</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Atencion primaria (AREA 1)</name>
      <address>
        <city>Santander</city>
        <state>Cantabria</state>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>elena Bustamante</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gerencia de atención primaria (área 4)</name>
      <address>
        <city>Torrelavega</city>
        <state>Cantabria</state>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jose Ramon fonfria</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>September 8, 2021</last_update_submitted>
  <last_update_submitted_qc>September 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>colchicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Colchicine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04416334
org study id: COLCHICOVID
nct id: NCT04416334
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a phase 3 clinical trial, randomized, single-center, opened, controlled, to evaluate
      efficacy and safety of early administration of colchicines in patients older than 60 years,
      with high risk of pulmonary complications due to coronavirus SARS-CoV2 (COVID-19). An
      approximately number of 954 subjects meeting all inclusion and none exclusion criteria will
      be randomized either to receive colchicines or symptomatic treatment with paracetamol during
      21 days.
The primary objective of the study is to determine whether short term course of colchicines
      reduces number of deaths due to COVID-19 and severe complications due to the virus in elderly
      patients with comorbidities.

      The secondary objective is to determine the safety of colchicines in this patient population.

      Approximately 954 subjects who meet all inclusion criteria and none exclusion criteria will
      be randomized either to receive colchicines or symptomatic treatment (2:1 allocation ratio)
      during 21 days. Follow-up assessments will occur every 48 hours and always at day 10, 21 and
      61 following randomization for evaluation of the occurrence of any trial endpoints or other
      adverse events.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of participants who die due to COVID-19 infection
time frame: 21 days post-randomization
measure: Number of participants who require hospitalization due to COVID-19 infection
time frame: 21 days post-randomization
measure: A confirmed diagnosis from COVID-19 infection (by positive PCR test) will be mandatory .
time frame: 48 hours
description: not delayed more than 48 hours from initial symptoms
arm group label: Colchicine plus symptomatic treatment (paracetamol).
arm group type: Experimental
description: Patients in this arm will receive study medication colchicines 0.5 mg orally (PO) twice daily for the first 3 days and then once daily for the last 18 days. If a dose is missed, it should not be replaced.
All patients should also receive best symptomatic treatment (mainly paracetamol), based on clinical practice.
arm group label: Symptomatic treatment
arm group type: Active Comparator
description: Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations).
intervention type: Drug
intervention name: Colchicine plus symptomatic treatment (paracetamol)
description: Colchicine plus symptomatic treatment (paracetamol).
arm group label: Colchicine plus symptomatic treatment (paracetamol).
intervention type: Drug
intervention name: Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations)
description: Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations).
arm group label: Symptomatic treatment
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Carlos Richard
phone: 942203333
email: carlos.richard@scsalud.es
last name: Mar García, PhD
phone: 942203333
email: mmar.garcia@scsalud.es
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Acetaminophen
mesh term: Colchicine