xml: <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/NCT06012565</url>
    </required_header>
    <id_info>
      <org_study_id>KAN0006</org_study_id>
      <secondary_id>2020-002322-85</secondary_id>
      <nct_id>NCT06012565</nct_id>
    </id_info>
    <brief_title>KAND567 Versus Placebo in Subjects Hospitalized With COVID-19</brief_title>
    <official_title>KAND567 Versus Placebo in Subjects Hospitalized With COVID-19. A Phase II, Randomized, 2-Arm Parallel-Group, Double-blind Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kancera AB</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kancera AB</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>
        The study is a phase II, randomized, 2-arm parallel-group, double-blind study to explore the&#xD;
        efficacy, safety, tolerability and pharmacokinetics of KAND567 versus placebo in COVID-19&#xD;
        subjects in need of oxygen treatment.&#xD;
  &#xD;
        The target was to include forty (40) subjects with diagnosed COVID-19 for participation in&#xD;
        the study. If at screening all criteria for study participation were fulfilled and informed&#xD;
        consent signed, the subject was enrolled and randomized into one of the two arms. After&#xD;
        randomization, the subjects were to receive KAND567 or placebo treatment for 7 days.&#xD;
  &#xD;
        After the treatment period the subjects returned to ordinary clinical follow-up, but a study&#xD;
        follow-up visit was to be planned for Day 21 and 90.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Terminated</overall_status>
    <why_stopped>
      Slow recruitment&#xD;
    </why_stopped>
    <start_date type="Actual">October 11, 2020</start_date>
    <completion_date type="Actual">August 7, 2021</completion_date>
    <primary_completion_date type="Actual">August 7, 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
      <masking_description>Statistician and Safety Review Committee are not blinded. Sponsor is blinded.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Safety and tolerability of KAND567, as measured by the occurrence of adverse events (AEs) and serious adverse events (SAEs).</measure>
      <time_frame>From the first IMP administration (Day 1) until the last follow-up visit (Day 90).</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">35</enrollment>
    <condition>Covid19</condition>
    <arm_group>
      <arm_group_label>KAND567</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>KAND567</intervention_name>
      <description>2 x 125 mg capsules for oral administration. KAND567 (250 mg) was to be given every 12 hours for one week (7 days).</description>
      <arm_group_label>KAND567</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Microcrystalline cellulose</intervention_name>
      <description>Capsules for oral administration, consisting of microcrystalline cellulose oral solid formulation in capsules. Placebo was to be given every 12 hours for one week (7 days).</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Written Informed Consent obtained and documented according to national/local&#xD;
               regulations prior to any study-specific procedure.&#xD;
  &#xD;
            -  Males and females aged ≥18-85 years at the time of signing the informed consent form.&#xD;
  &#xD;
            -  Patients with symptoms and signs of SARS-CoV-2 infection according to the World Health&#xD;
               Organization (WHO) case definition. Symptoms must include shortness of breath, with an&#xD;
               onset which occurred ≤ 10 days before admission, and the COVID-19 diagnosis must be&#xD;
               confirmed by laboratory testing (PCR-positive). In addition, moderately impaired&#xD;
               oxygenation as demonstrated by oxygen saturation ≤ 93% but ≥ 87% on room air, or&#xD;
               requiring 1-5 L/min of oxygen to obtain an oxygen saturation of ≥ 92%, and at least&#xD;
               one of the following laboratory values:&#xD;
  &#xD;
          (A) Ferritin: &gt; 300 ng/mL for men and &gt; 150 ng/mL for women. (B) C-reactive protein (CRP):&#xD;
          ≥ 10 mg/L. (C) D-dimer elevated above the age-adjusted lower limit: (i) ≤ 50 years; &lt; 0.5&#xD;
          mg/L FEU (Fibrinogen Equivalent Units). (ii) &gt; 50 years; age-related, calculated as&#xD;
          follows: 0.5 mg/L FEU + 0.01 mg/L FEU for every year over 50 (i.e., one who is 70 years old&#xD;
          has thus a reference limit of &lt; 0.7 mg/L FEU; one who is 90 years old has a reference limit&#xD;
          of &lt; 0.9 mg/L FEU).&#xD;
  &#xD;
            -  Able to swallow capsules&#xD;
  &#xD;
            -  Male subject must be willing to use condoms with spermicide, and if he has a fertile&#xD;
               partner, she must use contraceptive methods with a failure rate of &lt; 1% to prevent&#xD;
               pregnancy. Male subjects must also refrain from donating sperm from the first dose&#xD;
               until three months after dosing with investigational product (IP). Female subjects&#xD;
               must be post-menopausal or use contraceptive methods with a failure rate of &lt; 1% to&#xD;
               prevent pregnancy.&#xD;
  &#xD;
            -  Willingness and ability to comply with study procedures, visit schedules, study&#xD;
               restrictions and requirements.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient not committed to aggressive management. For example, the subject, the&#xD;
               subject's family or primary physician are unwilling to accept that the subject is&#xD;
               placed on mechanical ventilation; or in the case of an advanced directive to withhold&#xD;
               life support, with the exception of cardiopulmonary resuscitation.&#xD;
  &#xD;
            -  A suspected, active bacterial, fungal, viral, or other infection (besides COVID 19).&#xD;
  &#xD;
            -  Alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) &gt; 2 times the&#xD;
               upper limit of normal (ULN) detected at screening (per local lab) or suspected liver&#xD;
               disease.&#xD;
  &#xD;
            -  Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the&#xD;
               last 6 weeks, or decompensated congestive heart failure.&#xD;
  &#xD;
            -  Any condition for which, in the opinion of the investigator, participation would not&#xD;
               be in the best interest of the participant (e.g., compromise the well-being) or that&#xD;
               could prevent, limit, or confound the protocol-specified assessments.&#xD;
  &#xD;
            -  Clinically verified pulmonary embolism&#xD;
  &#xD;
            -  Chronic use of oral corticosteroids for treatment of inflammatory disease&#xD;
  &#xD;
            -  Use of strong CYP3A4 inhibitors (e.g., azoleantifungals, macrolide antibiotics,&#xD;
               protease inhibitors) or inducers (e.g., rifabutin and rifampicin) and drugs sensitive&#xD;
               to CYP3A4 inhibition (e.g., benzodiazepines, certain statins [lovastatin and&#xD;
               simvastatin], certain P2Y12 inhibitors [ticagrelor and clopidogrel]).&#xD;
  &#xD;
            -  Participation in another pharmaceutical clinical study.&#xD;
  &#xD;
            -  Subject who has received any investigational drug within the last 3 months before&#xD;
               administration of the investigational medicinal product (IMP).&#xD;
  &#xD;
            -  Severe COVID-19 at randomization: requiring non-invasive or invasive mechanical&#xD;
               ventilation or Intensive Care Unit (ICU) admission for any other cause than&#xD;
               respiratory support.&#xD;
  &#xD;
            -  Patients judged not to be suitable for non-invasive monitoring of oxygen saturation&#xD;
               because of impaired peripheral circulation or for other reasons.&#xD;
  &#xD;
            -  Active malignancy with or without treatment, except local basal cell carcinoma.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mantas Okas, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Capio St. Görans Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Hvidovre Hospital</name>
        <address>
          <city>Hvidovre</city>
          <zip>2650</zip>
          <country>Denmark</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Odense University Hospital</name>
        <address>
          <city>Odense</city>
          <zip>5000</zip>
          <country>Denmark</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Capio St. Görans Hospital</name>
        <address>
          <city>Stockholm</city>
          <zip>11281</zip>
          <country>Sweden</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Västmanlands Hospital</name>
        <address>
          <city>Västerås</city>
          <zip>721 89</zip>
          <country>Sweden</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Denmark</country>
      <country>Sweden</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</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>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06012565
  org study id: KAN0006
  secondary id: 2020-002322-85
  nct id: NCT06012565
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The study is a phase II, randomized, 2-arm parallel-group, double-blind study to explore the
        efficacy, safety, tolerability and pharmacokinetics of KAND567 versus placebo in COVID-19
        subjects in need of oxygen treatment.
  
        The target was to include forty (40) subjects with diagnosed COVID-19 for participation in
        the study. If at screening all criteria for study participation were fulfilled and informed
        consent signed, the subject was enrolled and randomized into one of the two arms. After
        randomization, the subjects were to receive KAND567 or placebo treatment for 7 days.
  
        After the treatment period the subjects returned to ordinary clinical follow-up, but a study
        follow-up visit was to be planned for Day 21 and 90.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  masking description: Statistician and Safety Review Committee are not blinded. Sponsor is blinded.
  measure: Safety and tolerability of KAND567, as measured by the occurrence of adverse events (AEs) and serious adverse events (SAEs).
  time frame: From the first IMP administration (Day 1) until the last follow-up visit (Day 90).
  arm group label: KAND567
  arm group type: Experimental
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: KAND567
  description: 2 x 125 mg capsules for oral administration. KAND567 (250 mg) was to be given every 12 hours for one week (7 days).
  arm group label: KAND567
  intervention type: Drug
  intervention name: Microcrystalline cellulose
  description: Capsules for oral administration, consisting of microcrystalline cellulose oral solid formulation in capsules. Placebo was to be given every 12 hours for one week (7 days).
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Mantas Okas, MD, PhD
  role: Principal Investigator
  affiliation: Capio St. Görans Hospital
  facility: 
  facility: 
  facility: 
  facility: 
  country: Denmark
  country: Sweden
  responsible party type: Sponsor
  mesh term: COVID-19
  sharing ipd: No