<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/NCT04403243</url>
  </required_header>
  <id_info>
    <org_study_id>MSU080520</org_study_id>
    <nct_id>NCT04403243</nct_id>
  </id_info>
  <brief_title>COLchicine Versus Ruxolitinib and Secukinumab in Open-label Prospective Randomized Trial in Patients With COVID-19</brief_title>
  <acronym>COLORIT</acronym>
  <official_title>COLchicine Versus Ruxolitinib and Secukinumab in Open-label Prospective Randomized Trial in Patients With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lomonosov Moscow State University Medical Research and Educational Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lomonosov Moscow State University Medical Research and Educational 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with mild and severe coronavirus disease 2019 (COVID 19) will be randomized 3:1:1:3&#xD;
      into four groups: colchicine, ruxolitinib, secukinumab, and control groups. . Patients will&#xD;
      be follow-up during 45 days after randomization. Change in clinical assessment score COVID 19&#xD;
      (CAS COVID 19) between baseline and 12th day will be evaluated as the primary endpoint. Risk&#xD;
      of death or mechanical ventilation during 45 days after randomization will also be assessed&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 8, 2020</start_date>
  <completion_date type="Actual">August 23, 2020</completion_date>
  <primary_completion_date type="Actual">July 22, 2020</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>Patients will be randomized 3:1:1:3 into four groups: colchicine, ruxolitinib, secukinumab, and control group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change from baseline in clinical assessment score COVID 19 (CAS COVID 19) Frame: baseline</measure>
    <time_frame>baseline, day 12</time_frame>
    <description>CAS COVID 19 measures clinical and laboratory parameters in 7 domains:&#xD;
respiratory rate (&lt; 18 - 0 point; 18-22 - 1 point; 23-26 - 2 point; &gt;26 - 3 point)&#xD;
body temperature (35.5 - 37.0 - 0 point; &lt; 35.5 - 1 point; 37.1 - 38.5 - 1 point; &gt; 38.5 - 2 point)&#xD;
Sp02 without support oxygen (&gt; 93% - 0 point; 90-93% - 1 point; &lt; 90% - 2 point)&#xD;
ventilation (not required - 0 point; low-flow ventilation - 1 point; Non-invasive positive pressure ventilation - 2 point; mechanical ventilation - 3 point)&#xD;
C-reactive protein (&gt; 10 - 0 point; 10-59 - 1 point; 60-120 - 2 point; &gt; 120 - 3 point)&#xD;
d - dimer (&lt; 0.51 - 0 point; 0.51 - 2.0 - 1 point; 2.01 - 5.0 - 2, &gt; 5.0 - 3 point)&#xD;
exposure area on lung CT (no pneumonia - 0; 1-24% - 1 point; 25-50% - 2; 51-75% - 3, &gt; 75% - 4).&#xD;
Minimal number of points - 0; max - 20. Lower the score-better health</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Combine endpoint: Time to death or mechanical ventilation</measure>
    <time_frame>45 days</time_frame>
    <description>time to death or mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>baseline, day 12, day 45</time_frame>
    <description>Change from baseline in C-reactive protein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>D-dimer</measure>
    <time_frame>baseline, day 12, day 45</time_frame>
    <description>Change from baseline in D-dimer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol Group. EQ-5D™</measure>
    <time_frame>baseline, day 12, day 45</time_frame>
    <description>Change from baseline in EQ-5D-3L™ The EQ-5D-3L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).&#xD;
The EQ-5D-3L descriptive system comprises the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box to the most appropriate statement. This decision results into a 1-digit number, . The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.&#xD;
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome by patient's own judgement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>exposure area on lung CT</measure>
    <time_frame>baseline, day 12, day 45</time_frame>
    <description>Change from baseline in exposure area on lung CT</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>COVID 19</condition>
  <arm_group>
    <arm_group_label>1. Colchicine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 Patients with mild and severe COVID 19 Patients will get investigated therapy for ten days. Patients will be follow-up during 45 days after randomization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2. Ruxolitinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 Patients with mild and severe COVID 19 Patients will get investigated therapy for ten days. Patients will be follow-up during 45 days after randomization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3.Secukinumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 Patients with mild and severe COVID 19 Patients will get investigated therapy singly. Patients will be follow-up during 45 days after randomization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4.Standard treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>-30 patients Patients with mild and severe COVID 19 Patients will get investigated therapy for ten days. Patients will be follow-up during 45 days after randomization</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Colchicine</intervention_name>
    <description>0.5mg twice a day per os during the first three days and then 0.5mg daily per os if weight &lt; 86 kg or 0.5mg twice a day per os if weight &gt; 85kg for seven days.</description>
    <arm_group_label>1. Colchicine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ruxolitinib 5 MG</intervention_name>
    <description>Ruxolitinib - 5mg twice a day per os for ten days</description>
    <arm_group_label>2. Ruxolitinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX]</intervention_name>
    <description>Secukinumab - 300mg subcutaneously singly</description>
    <arm_group_label>3.Secukinumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard therapy</intervention_name>
    <description>standard therapy for COVID 19</description>
    <arm_group_label>4.Standard treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed inform consent&#xD;
&#xD;
          -  COVID 19 with the mild and severe course. The diagnosis could be made with positive&#xD;
             polymerase chain reaction (PCR) (International Statistical Classification (ICD-10)&#xD;
             code - U07.1) and/or virus pneumonia in computer tomography (ICD 10 code - U07.2)&#xD;
&#xD;
          -  Lung exposure on CT more than 25%&#xD;
&#xD;
          -  Sp02 without supportive oxygen ≤ 93%&#xD;
&#xD;
          -  C-reactive protein &gt; 60 mg/l or elevation of C reactive protein 3 times in 8-14 days&#xD;
             after first symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy and breastfeeding&#xD;
&#xD;
          -  hypersensitivity to colchicine&#xD;
&#xD;
          -  hypersensitivity to ruxolitinib&#xD;
&#xD;
          -  hypersensitivity to secukinumab&#xD;
&#xD;
          -  Known liver failure&#xD;
&#xD;
          -  Glomerular filtration rate &lt;20 ml/ min&#xD;
&#xD;
          -  physician judgment that the patient will need mechanical ventilation in 24 hours&#xD;
&#xD;
          -  QTc &gt; 450 ms&#xD;
&#xD;
          -  other indications for to colchicine, ruxolitinib, and secukinumab&#xD;
&#xD;
          -  Chronic therapy with corticosteroids or immunosuppressive therapy&#xD;
&#xD;
          -  Active cancer&#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>Lomonosov Moscow State University Medical Research and Educational Center</name>
      <address>
        <city>Moscow</city>
        <state>Moscow Region</state>
        <zip>119620</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>November 21, 2022</last_update_submitted>
  <last_update_submitted_qc>November 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID 19</keyword>
  <keyword>colchicine</keyword>
  <keyword>ruxolitinib</keyword>
  <keyword>secukinumab</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>Colchicine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>4 month</ipd_time_frame>
    <ipd_access_criteria>Medical professionals By the request</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/NCT04403243
org study id: MSU080520
nct id: NCT04403243
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with mild and severe coronavirus disease 2019 (COVID 19) will be randomized 3:1:1:3
      into four groups: colchicine, ruxolitinib, secukinumab, and control groups. . Patients will
      be follow-up during 45 days after randomization. Change in clinical assessment score COVID 19
      (CAS COVID 19) between baseline and 12th day will be evaluated as the primary endpoint. Risk
      of death or mechanical ventilation during 45 days after randomization will also be assessed
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomized 3:1:1:3 into four groups: colchicine, ruxolitinib, secukinumab, and control group
primary purpose: Treatment
masking: None (Open Label)
measure: change from baseline in clinical assessment score COVID 19 (CAS COVID 19) Frame: baseline
time frame: baseline, day 12
description: CAS COVID 19 measures clinical and laboratory parameters in 7 domains:
respiratory rate (< 18 - 0 point; 18-22 - 1 point; 23-26 - 2 point; >26 - 3 point)
body temperature (35.5 - 37.0 - 0 point; < 35.5 - 1 point; 37.1 - 38.5 - 1 point; > 38.5 - 2 point)
Sp02 without support oxygen (> 93% - 0 point; 90-93% - 1 point; < 90% - 2 point)
ventilation (not required - 0 point; low-flow ventilation - 1 point; Non-invasive positive pressure ventilation - 2 point; mechanical ventilation - 3 point)
C-reactive protein (> 10 - 0 point; 10-59 - 1 point; 60-120 - 2 point; > 120 - 3 point)
d - dimer (< 0.51 - 0 point; 0.51 - 2.0 - 1 point; 2.01 - 5.0 - 2, > 5.0 - 3 point)
exposure area on lung CT (no pneumonia - 0; 1-24% - 1 point; 25-50% - 2; 51-75% - 3, > 75% - 4).
Minimal number of points - 0; max - 20. Lower the score-better health
measure: Combine endpoint: Time to death or mechanical ventilation
time frame: 45 days
description: time to death or mechanical ventilation
measure: C-reactive protein
time frame: baseline, day 12, day 45
description: Change from baseline in C-reactive protein
measure: D-dimer
time frame: baseline, day 12, day 45
description: Change from baseline in D-dimer
measure: EuroQol Group. EQ-5D™
time frame: baseline, day 12, day 45
description: Change from baseline in EQ-5D-3L™ The EQ-5D-3L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The EQ-5D-3L descriptive system comprises the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box to the most appropriate statement. This decision results into a 1-digit number, . The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome by patient's own judgement.
measure: exposure area on lung CT
time frame: baseline, day 12, day 45
description: Change from baseline in exposure area on lung CT
arm group label: 1. Colchicine
arm group type: Experimental
description: 30 Patients with mild and severe COVID 19 Patients will get investigated therapy for ten days. Patients will be follow-up during 45 days after randomization
arm group label: 2. Ruxolitinib
arm group type: Experimental
description: 10 Patients with mild and severe COVID 19 Patients will get investigated therapy for ten days. Patients will be follow-up during 45 days after randomization
arm group label: 3.Secukinumab
arm group type: Experimental
description: 10 Patients with mild and severe COVID 19 Patients will get investigated therapy singly. Patients will be follow-up during 45 days after randomization
arm group label: 4.Standard treatment
arm group type: Active Comparator
description: -30 patients Patients with mild and severe COVID 19 Patients will get investigated therapy for ten days. Patients will be follow-up during 45 days after randomization
intervention type: Drug
intervention name: Colchicine
description: 0.5mg twice a day per os during the first three days and then 0.5mg daily per os if weight < 86 kg or 0.5mg twice a day per os if weight > 85kg for seven days.
arm group label: 1. Colchicine
intervention type: Drug
intervention name: Ruxolitinib 5 MG
description: Ruxolitinib - 5mg twice a day per os for ten days
arm group label: 2. Ruxolitinib
intervention type: Drug
intervention name: Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX]
description: Secukinumab - 300mg subcutaneously singly
arm group label: 3.Secukinumab
intervention type: Other
intervention name: standard therapy
description: standard therapy for COVID 19
arm group label: 4.Standard treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Colchicine
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: 4 month
ipd access criteria: Medical professionals By the request