<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/NCT04425772</url>
  </required_header>
  <id_info>
    <org_study_id>FNC-Hope4</org_study_id>
    <nct_id>NCT04425772</nct_id>
  </id_info>
  <brief_title>A Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19）</brief_title>
  <official_title>A Randomized,Double Blinded, Double Dummy, Parallel Controlled Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19）</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HeNan Sincere Biotech Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HeNan Sincere Biotech Co., Ltd</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>
      To evaluate the efficacy and safety of azvudine in treatment of COVID-19&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 12, 2020</start_date>
  <completion_date type="Anticipated">August 12, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 12, 2020</primary_completion_date>
  <phase>N/A</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change (reduction) in viral load from baseline</measure>
    <time_frame>On day 7 and 14</time_frame>
    <description>(reduction) in viral load from baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>proportion of subjects change from mild or moderate type to severe type</measure>
    <time_frame>up to 21 days</time_frame>
    <description>proportion of subjects change from mild or moderate type to severe type</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proportion of subjects change from severe type to critical type</measure>
    <time_frame>up to 21 days</time_frame>
    <description>proportion of subjects change from severe type to critical type</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>novel coronavirus nucleic acid conversion rate</measure>
    <time_frame>up to 21 days</time_frame>
    <description>novel coronavirus nucleic acid conversion rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Novel coronavirus nucleic acid negative conversion time</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Novel coronavirus nucleic acid negative conversion time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time and proportion of improvement in pulmonary imaging</measure>
    <time_frame>up to 21 days</time_frame>
    <description>TIme(Days);Proportion(percent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time and proportion of temperature return to normal</measure>
    <time_frame>up to 21 days</time_frame>
    <description>TIme(Days);Proportion(percent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time and rate of improvement of respiratory symptoms and signs (lung rhones, cough, sputum, sore throat, etc.)</measure>
    <time_frame>up to 21 days</time_frame>
    <description>TIme(Days);Proportion(percent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms</measure>
    <time_frame>up to 21 days</time_frame>
    <description>TIme(Days);Proportion(percent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of blood oxygen detection index</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Changes of blood oxygen detection index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of requirement for supplemental oxygen or non-invasive ventilation</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Frequency of requirement for supplemental oxygen or non-invasive ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of adverse events</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Frequency of adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">342</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FNC+Standard of Care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>FNC dummy tablet+ Standard of Care</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FNC+Standard of Care</intervention_name>
    <description>FNC + Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria</description>
    <arm_group_label>Experimental Group</arm_group_label>
    <other_name>Azvudine+SOC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FNC dummy tablet+Standard of Care</intervention_name>
    <description>FNC dummy tablet+ Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria</description>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>Azvudin dummy tablet+SOC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age ≥18 years old, gender not limited;&#xD;
&#xD;
          2. Laboratory (RT-PCR) confirmed COVID-19;&#xD;
&#xD;
          3. the time from the first positive nucleic acid test to randomization does not exceed&#xD;
             more than 4 days;&#xD;
&#xD;
          4. informed consent has been signed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. known or suspected allergies to the components of azivudine tablets;&#xD;
&#xD;
          2. according to the latest version of the National Health and Medical Commission&#xD;
             Diagnostic criteria of COVID-19, patients with severe novel coronavirus pneumonia was&#xD;
             confirmed;&#xD;
&#xD;
          3. severe liver disease (TBIL&gt;=2 times normal upper limit; ALTAST&gt;=5 times normal upper&#xD;
             limit);&#xD;
&#xD;
          4. subjects with severe renal insufficiency (glomerular filtration rate ≤60 mL/min/1.73&#xD;
             m2) or undergoing continuous renal replacement therapy, hemodialysis or peritoneal&#xD;
             dialysis;&#xD;
&#xD;
          5. subjects with complication of malabsorption syndrome or any other condition affecting&#xD;
             gastrointestinal absorption, requiring intravenous nutrition or not being able to take&#xD;
             drugs orally;&#xD;
&#xD;
          6. subjectsis currently receiving anti-hiv treatment;&#xD;
&#xD;
          7. women who are breast-feeding during pregnancy or have a family plan during the trial&#xD;
             period and within 6 months after the end of the trial;&#xD;
&#xD;
          8. participating in other clinical trials or using experimental drugs, except traditional&#xD;
             Chinese medicine;&#xD;
&#xD;
          9. Other conditions that not appropriate to be enrolled into this study based on&#xD;
             investigator's advise.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</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>
    <mesh_term>Pneumonia</mesh_term>
  </condition_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/NCT04425772
org study id: FNC-Hope4
nct id: NCT04425772
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To evaluate the efficacy and safety of azvudine in treatment of COVID-19
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change (reduction) in viral load from baseline
time frame: On day 7 and 14
description: (reduction) in viral load from baseline
measure: proportion of subjects change from mild or moderate type to severe type
time frame: up to 21 days
description: proportion of subjects change from mild or moderate type to severe type
measure: proportion of subjects change from severe type to critical type
time frame: up to 21 days
description: proportion of subjects change from severe type to critical type
measure: novel coronavirus nucleic acid conversion rate
time frame: up to 21 days
description: novel coronavirus nucleic acid conversion rate
measure: Novel coronavirus nucleic acid negative conversion time
time frame: up to 21 days
description: Novel coronavirus nucleic acid negative conversion time
measure: The time and proportion of improvement in pulmonary imaging
time frame: up to 21 days
description: TIme(Days);Proportion(percent)
measure: Time and proportion of temperature return to normal
time frame: up to 21 days
description: TIme(Days);Proportion(percent)
measure: time and rate of improvement of respiratory symptoms and signs (lung rhones, cough, sputum, sore throat, etc.)
time frame: up to 21 days
description: TIme(Days);Proportion(percent)
measure: time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms
time frame: up to 21 days
description: TIme(Days);Proportion(percent)
measure: Changes of blood oxygen detection index
time frame: up to 21 days
description: Changes of blood oxygen detection index
measure: Frequency of requirement for supplemental oxygen or non-invasive ventilation
time frame: up to 21 days
description: Frequency of requirement for supplemental oxygen or non-invasive ventilation
measure: Frequency of adverse events
time frame: up to 21 days
description: Frequency of adverse events
arm group label: Experimental Group
arm group type: Experimental
description: FNC+Standard of Care
arm group label: Control Group
arm group type: Placebo Comparator
description: FNC dummy tablet+ Standard of Care
intervention type: Drug
intervention name: FNC+Standard of Care
description: FNC + Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria
arm group label: Experimental Group
other name: Azvudine+SOC
intervention type: Drug
intervention name: FNC dummy tablet+Standard of Care
description: FNC dummy tablet+ Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria
arm group label: Control Group
other name: Azvudin dummy tablet+SOC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia