<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/NCT04475107</url>
  </required_header>
  <id_info>
    <org_study_id>SP-PA-COV-201</org_study_id>
    <nct_id>NCT04475107</nct_id>
  </id_info>
  <brief_title>The Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients</brief_title>
  <official_title>A Multi-center, Randomized, Double-blind, Parallel, Placebo-Controlled, Phase Ⅱ Clinical Trial to Evaluate Efficacy and Safety of Pyramax in Mild to Moderate COVID-19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shin Poong Pharmaceutical Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shin Poong Pharmaceutical Co. Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a multi-center, randomized, double-blind, parallel, placebo-controlled, phase Ⅱ&#xD;
      clinical trial to evaluate efficacy and safety of Pyramax in mild to moderate COVID-19&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 9, 2020</start_date>
  <completion_date type="Actual">April 15, 2021</completion_date>
  <primary_completion_date type="Actual">March 25, 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, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion (%) of patients with virological clearance of SARS-CoV-2 at day 7 post-dose*</measure>
    <time_frame>Day 7</time_frame>
    <description>* Patients who are rRT-PCR negative for COVID-19</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Viral load reduction of SARS-CoV-2 at Day 3, 7, 10, and 14 post-dose compared to the baseline</measure>
    <time_frame>Day 3, 7, 10, 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion (%) of patients with virological clearance of SARS-CoV-2 at Day 3, 10, and 14 post-dose*</measure>
    <time_frame>Day 3, 10, 14</time_frame>
    <description>* Patients who are rRT-PCR negative for COVID-19</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in WHO Ordinal Scale for Clinical Improvement at Day 3, 7, 10, 14, and 28 post-dose from the baseline</measure>
    <time_frame>Day 3, 7, 10, 14, 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in NEWS score at Day 3, 7, 10, 14, and 28 post-dose from the baseline</measure>
    <time_frame>Day 3, 7, 10, 14, 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to achieve normalization of body temperature, post-dose</measure>
    <time_frame>Day 3, 7, 10, 14, 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to achieve normalization of respiratory rate, post-dose</measure>
    <time_frame>Day 3, 7, 10, 14, 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to achieve normalization of oxygen saturation, post-dose</measure>
    <time_frame>Day 3, 7, 10, 14, 28</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">113</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pyramax (Pyronaridine 180mg/ Artesunate 60mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pyronaridine-Artesunate</intervention_name>
    <description>Pyramax</description>
    <arm_group_label>Arm A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥19 years at the time of signing Informed Consent Form&#xD;
&#xD;
          2. Body weight ≥45 kg at screening&#xD;
&#xD;
          3. Laboratory (rRT-PCR) confirmed infection with SARS-CoV-2 by testing specimens from&#xD;
             upper airway (i.e. nasopharyngeal and oropharyngeal swab) or lower airway (i.e.&#xD;
             sputum) within 96 hours of randomization&#xD;
&#xD;
          4. Oxygen saturation(SpO2) &gt; 94% at randomization, in room air condition&#xD;
&#xD;
          5. Willing and able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosed with severe pneumonia&#xD;
&#xD;
          2. Patients with clinically significant cardiovascular disease (including arrhythmia, QTc&#xD;
             interval prolongation)&#xD;
&#xD;
          3. Patients with clinically significant anemia (Hemoglobin &lt;8.0 g/dL)&#xD;
&#xD;
          4. Patient with known allergic reaction or contraindication to any of the investigational&#xD;
             medicinal product (pyronaridine tetraphosphate, artesunate)&#xD;
&#xD;
          5. Patients with known history of galactose intolerance, Lapp lactase deficiency or&#xD;
             glucose-galactose malabsorption, etc.&#xD;
&#xD;
          6. Patients with the gastrointestinal disease and surgery to affect the absorption,&#xD;
             distribution, metabolism and excretion of the drug, active gastritis, gastrointestinal&#xD;
             tract / rectal bleeding, gastric ulcer, pancreatitis abnormalities (except simple&#xD;
             appendectomy or hernia surgery)&#xD;
&#xD;
          7. Patients who received antiviral drugs that is intended to treat COVID-19, within 28&#xD;
             days prior to screening evaluation (can be enrolled into the study, if the patient has&#xD;
             gone through a sufficient wash-out period)&#xD;
&#xD;
          8. Patients with known severe renal impairment (estimated glomerular filtration rate ≤30&#xD;
             mL/min/1.73 m2)&#xD;
&#xD;
          9. Patients with known severe liver disease (i.e. ALT or AST&gt;5 times upper limit, nausea,&#xD;
             abdominal pain associated with jaundice or Child-Pugh stage B or C)&#xD;
&#xD;
         10. Viral disease (HIV, HBV, HCV, etc.) other than COVID-19 that require administration of&#xD;
             other antiviral agents&#xD;
&#xD;
         11. Patients that require ventilation therapy (e.g. non-invasive ventilation, invasive&#xD;
             mechanical ventilation, extracorporeal membrane oxygenation, etc.)&#xD;
&#xD;
         12. Patients with chronic underlying disease (e.g. uncontrolled diabetes mellitus, chronic&#xD;
             kidney disease, chronic liver disease, chronic pulmonary disease, chronic&#xD;
             cardiovascular disease, blood cancer, cancer patients with cancer treatment, patients&#xD;
             taking immunosuppressants), highly obese patients, dialysis patients, and transplant&#xD;
             patients that are determined by the Physician, to be not suitable for trial&#xD;
             involvement.&#xD;
&#xD;
         13. Pregnant or lactating women&#xD;
&#xD;
         14. Male or female of childbearing potential who has plans to become pregnant during the&#xD;
             study period and for three months after the clinical study or who is not willing to&#xD;
             take appropriate contraceptive measures&#xD;
&#xD;
             *Hormonal contraception (contraceptive implant, injections, pills, etc.), IUDs,&#xD;
             condoms (male) and contraceptive diaphragm or cap (female), sterilization (vasectomy,&#xD;
             tubal ligation, etc.)&#xD;
&#xD;
         15. Participating in another clinical trial currently or within 28 days from signing the&#xD;
             informed consent&#xD;
&#xD;
         16. Patients that are deemed ineligible to participate in the clinical trial by the&#xD;
             Investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Korea University Ansan Hospital</name>
      <address>
        <city>Ansan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chungnam national University Hospital</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inha University Hospital</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gangnam Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hallym University Kangnam Sacred Heart Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Guro Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyungpook National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sahmyook Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Eunpyeong St. Marys' Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Suwon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>May 27, 2021</last_update_submitted>
  <last_update_submitted_qc>May 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pyramax</keyword>
  <keyword>Pyronaridine</keyword>
  <keyword>Artesunate</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Corona virus</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>Artesunate</mesh_term>
    <mesh_term>Pyronaridine</mesh_term>
    <mesh_term>Pyronaridine tetraphosphate, artesunate drug combination</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/NCT04475107
org study id: SP-PA-COV-201
nct id: NCT04475107
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is a multi-center, randomized, double-blind, parallel, placebo-controlled, phase Ⅱ
      clinical trial to evaluate efficacy and safety of Pyramax in mild to moderate COVID-19
      patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Proportion (%) of patients with virological clearance of SARS-CoV-2 at day 7 post-dose*
time frame: Day 7
description: * Patients who are rRT-PCR negative for COVID-19
measure: Viral load reduction of SARS-CoV-2 at Day 3, 7, 10, and 14 post-dose compared to the baseline
time frame: Day 3, 7, 10, 14
measure: Proportion (%) of patients with virological clearance of SARS-CoV-2 at Day 3, 10, and 14 post-dose*
time frame: Day 3, 10, 14
description: * Patients who are rRT-PCR negative for COVID-19
measure: Change in WHO Ordinal Scale for Clinical Improvement at Day 3, 7, 10, 14, and 28 post-dose from the baseline
time frame: Day 3, 7, 10, 14, 28
measure: Change in NEWS score at Day 3, 7, 10, 14, and 28 post-dose from the baseline
time frame: Day 3, 7, 10, 14, 28
measure: Time to achieve normalization of body temperature, post-dose
time frame: Day 3, 7, 10, 14, 28
measure: Time to achieve normalization of respiratory rate, post-dose
time frame: Day 3, 7, 10, 14, 28
measure: Time to achieve normalization of oxygen saturation, post-dose
time frame: Day 3, 7, 10, 14, 28
arm group label: Arm A
arm group type: Experimental
description: Pyramax (Pyronaridine 180mg/ Artesunate 60mg)
arm group label: Arm B
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: Pyronaridine-Artesunate
description: Pyramax
arm group label: Arm A
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Arm B
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Artesunate
mesh term: Pyronaridine
mesh term: Pyronaridine tetraphosphate, artesunate drug combination