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/NCT05996770</url>
    </required_header>
    <id_info>
      <org_study_id>LCYX-LX-20230102</org_study_id>
      <nct_id>NCT05996770</nct_id>
    </id_info>
    <brief_title>Evaluation of the Safety and Efficacy of Azvudine and Paxlovid in the Treatment of Hospitalized Patients With COVID-19</brief_title>
    <official_title>Evaluation of the Safety and Efficacy of Azvudine and Paxlovid in the Treatment of Hospitalized Patients With COVID-19</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xiao Li，MD</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Qianfoshan Hospital</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>
        In this retrospective study, we aimed to evaluate the clinical efficacy and safety of two&#xD;
        antiviral drugs on COVID-19 and inpatients with existing complications in the First&#xD;
        Affiliated Hospital of Shandong First Medical University. In addition, we also explored a key&#xD;
        issue. Is the combined treatment effect of two antiviral drugs, Paxlovid and Azvudine, better&#xD;
        than the use of a single drug?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        We conducted a single center retrospective cohort study on hospitalized patients with severe&#xD;
        acute respiratory syndrome coronavirus type 2 infection who received treatment with&#xD;
        nimatevir/ritonavir tablets or azivudine tablets at the First Affiliated Hospital of Shandong&#xD;
        First Medical University from December 1，2022 to January 31，2023. In the research of this&#xD;
        project, it is necessary to extract, sort out and retrospectively analyze the clinical data&#xD;
        of all patients with COVID-19 who have received Nematovir/Ritonavir tablets or Azivudine&#xD;
        tablets in the First Affiliated Hospital of Shandong First Medical University (Shandong&#xD;
        Qianfoshan Hospital), and respectively identify the relevant epidemiological characteristics&#xD;
        of COVID-19 patients, It is planned to use multiple linear regression or logical regression&#xD;
        model to explore the relevant factors that affect the drug use efficiency index, safety index&#xD;
        and total cost of patients with COVID-19, so as to provide scientific and quantitative&#xD;
        evidence support for the drug use mode of the disease, the clinical value of the drug and the&#xD;
        rational drug use of patients, and also provide favorable basis for the supervision and&#xD;
        decision-making of smart pharmacy of medical institutions.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>mortality</measure>
      <time_frame>Through study completion，up to half a year.</time_frame>
      <description>Mortality rate of patients with COVID-19 treated with COVID-19 Medicine</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">1500</enrollment>
    <condition>Paxlovid</condition>
    <condition>Azvudine</condition>
    <condition>COVID-19</condition>
    <arm_group>
      <arm_group_label>Patients with COVID-19 packaged with Paxlovid</arm_group_label>
      <description>Treatment of patients with COVID-19 with Paxlovid</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients with COVID-19 packaged with Azvudine</arm_group_label>
      <description>Treatment of patients with COVID-19 with Azvudine</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients with COVID-19 packaged with Paxlovid and Azvudine</arm_group_label>
      <description>Treatment of patients with COVID-19 with Paxlovid and Azvudine</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          All inpatients who were treated with nimatevir/ritonavir tablets and azivudine tablets at&#xD;
          the First Affiliated Hospital of Shandong First Medical University from December 1,2022 to&#xD;
          January 31,2023.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. The patient's admission time is from December 1,2022 to January 31,2023. 2. The&#xD;
               patient has used either Paxlovid or azivudine tablets during admission. 3. Age ≥ 18&#xD;
               years old. Exclusion Criteria：&#xD;
  &#xD;
            -  1. Patients using other antiviral drugs. 2. Patients with incomplete clinical data.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Xiao Li</last_name>
      <phone>18210590697</phone>
      <email>lixiao1688@163.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Qianfoshan Hospital</investigator_affiliation>
      <investigator_full_name>Xiao Li，MD</investigator_full_name>
      <investigator_title>Associate professor of pharmacy</investigator_title>
    </responsible_party>
    <keyword>Paxlovid</keyword>
    <keyword>Azvudine</keyword>
    <keyword>COVID-19</keyword>
    <keyword>effectiveness</keyword>
    <keyword>real-world evidence</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
    </condition_browse>
    <!-- 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/NCT05996770
  org study id: LCYX-LX-20230102
  nct id: NCT05996770
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  In this retrospective study, we aimed to evaluate the clinical efficacy and safety of two
        antiviral drugs on COVID-19 and inpatients with existing complications in the First
        Affiliated Hospital of Shandong First Medical University. In addition, we also explored a key
        issue. Is the combined treatment effect of two antiviral drugs, Paxlovid and Azvudine, better
        than the use of a single drug?
  We conducted a single center retrospective cohort study on hospitalized patients with severe
        acute respiratory syndrome coronavirus type 2 infection who received treatment with
        nimatevir/ritonavir tablets or azivudine tablets at the First Affiliated Hospital of Shandong
        First Medical University from December 1，2022 to January 31，2023. In the research of this
        project, it is necessary to extract, sort out and retrospectively analyze the clinical data
        of all patients with COVID-19 who have received Nematovir/Ritonavir tablets or Azivudine
        tablets in the First Affiliated Hospital of Shandong First Medical University (Shandong
        Qianfoshan Hospital), and respectively identify the relevant epidemiological characteristics
        of COVID-19 patients, It is planned to use multiple linear regression or logical regression
        model to explore the relevant factors that affect the drug use efficiency index, safety index
        and total cost of patients with COVID-19, so as to provide scientific and quantitative
        evidence support for the drug use mode of the disease, the clinical value of the drug and the
        rational drug use of patients, and also provide favorable basis for the supervision and
        decision-making of smart pharmacy of medical institutions.
  observational model: Other
  time perspective: Retrospective
  measure: mortality
  time frame: Through study completion，up to half a year.
  description: Mortality rate of patients with COVID-19 treated with COVID-19 Medicine
  arm group label: Patients with COVID-19 packaged with Paxlovid
  description: Treatment of patients with COVID-19 with Paxlovid
  arm group label: Patients with COVID-19 packaged with Azvudine
  description: Treatment of patients with COVID-19 with Azvudine
  arm group label: Patients with COVID-19 packaged with Paxlovid and Azvudine
  description: Treatment of patients with COVID-19 with Paxlovid and Azvudine
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Xiao Li
  phone: 18210590697
  email: lixiao1688@163.com
  responsible party type: Sponsor-Investigator
  investigator affiliation: Qianfoshan Hospital
  investigator full name: Xiao Li，MD
  investigator title: Associate professor of pharmacy
  mesh term: COVID-19