<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/NCT03787459</url>
  </required_header>
  <id_info>
    <org_study_id>CAP-China Arbidol</org_study_id>
    <nct_id>NCT03787459</nct_id>
  </id_info>
  <brief_title>Severe Influenza Trial of ARbidol</brief_title>
  <acronym>STAR</acronym>
  <official_title>Oseltamivir and Arbidol Combination Antiviral Therapy Versus Oseltamivir Monotherapy for the Treatment of Severe inﬂuenza: a Multicentre, Double-blind, Randomised Phase 3 Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Capital Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Capital Medical University</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>
      This is a multicenter, randomised, double-blind, controlled study to assess the efficacy and&#xD;
      safety of arbidol plus oseltamivir, compared with oseltamivir alone in approximately 200&#xD;
      hospitalized adults and adolescent patients with confirmed severe influenza. Patients should&#xD;
      be randomised as soon as possible after screening (no later than 12 hours), providing they&#xD;
      are within 7 days of symptom onset. Patients will be assigned in a 1:1 ratio to receive an&#xD;
      arbidol plus oseltamivir, or oseltamivir plus placebo. Rescreening of patients who fail to&#xD;
      meet the inclusion and exclusion criteria will be permitted only once, providing the time&#xD;
      from symptom onset to randomization is still within 7 days.&#xD;
&#xD;
      Arbidol/placebo will be administrated as 200mg TID from Days 1-7. Oseltamivir will be&#xD;
      administered as 75mg twice daily from Days 1-7 (dose to be adjusted for renal impairment).&#xD;
      Oseltamivir could be continued till influenza PCR negative. Both drugs, along with the&#xD;
      corresponding placebo for arbidol, will be started at the time of randomization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 18, 2019</start_date>
  <completion_date type="Anticipated">August 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">March 30, 2020</primary_completion_date>
  <phase>Phase 3</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>The primary efficacy endpoint was time to clinical status improvement (the event) up to 28 days</measure>
    <time_frame>28 days</time_frame>
    <description>the event defined as seven-category ordinal scale of clinical status after enrolment decrease by two category or discharged</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>oseltamivir plus placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>oseltamivir plus arbidol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Arbidol</intervention_name>
    <description>Oseltamivir plus Arbidol will be administrated from Days 1-7.</description>
    <arm_group_label>oseltamivir plus arbidol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Oseltamivir plus placebos will be administrated from Days 1-7.</description>
    <arm_group_label>oseltamivir plus placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Hospitalized males or females with a positive PCR test for influenza virus infection&#xD;
&#xD;
          2. Age ≥16 years at the time of signing Informed Consent Form&#xD;
&#xD;
          3. Arterial oxygen saturation (SaO2)/ pulse oxygen saturation (SPO2) ≤94% in room air&#xD;
             condition&#xD;
&#xD;
          4. ≤ 7 days since symptom onset. The onset of symptoms is defined as either: Time of the&#xD;
             first increase in body temperature (an increase of at least 1ºC from normal body&#xD;
             temperature- ≥38℃); Time when the patient experiences at least one general or&#xD;
             respiratory symptom.&#xD;
&#xD;
          5. Willingness to use contraception for 7 days after the end of treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Physicians make a decision that trial involvement is not in patients' best interest,&#xD;
             or any condition that does not allow the protocol to be followed safely.&#xD;
&#xD;
          2. Patient refusal to accept invasive organ support treatment if needed&#xD;
&#xD;
          3. More than 3 consecutive doses of NAIs within 2 days before enrolment (including&#xD;
             oseltamivir, zanamivir, peramivir)&#xD;
&#xD;
          4. Women who are pregnant (including a positive pregnancy test at enrolment),&#xD;
             breastfeeding, or within 2 weeks post-partum.&#xD;
&#xD;
             The following female subjects do not need to undergo a pregnancy test at enrolment: a.&#xD;
             Postmenopausal (defined as cessation of regular menstrual periods for 2 years or more&#xD;
             and confirmed by a follicle-stimulating hormone test) women. b. Women who are&#xD;
             surgically sterile by hysterectomy, bilateral oophorectomy, or tubal ligation.&#xD;
&#xD;
          5. Any condition requiring renal replacement therapy&#xD;
&#xD;
          6. Severe liver disease (Child-Pugh score ≥ C)&#xD;
&#xD;
          7. A history of hypersensitivity to arbidol or oseltamivir (Tamiflu®)&#xD;
&#xD;
          8. Currently or have been involved in another anti-influenza treatment trial in the last&#xD;
             28 days&#xD;
&#xD;
          9. Patients who, in the opinion of the investigator, would be unlikely to comply with&#xD;
             required study visits, self-assessments, and interventions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>China-Japan Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bin Cao, MD</last_name>
      <phone>+8684206264</phone>
      <email>caobin_ben@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Yeming Wang, MD</last_name>
      <phone>+8618810663558</phone>
      <email>wwyymm_love@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 22, 2018</study_first_submitted>
  <study_first_submitted_qc>December 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Capital Medical University</investigator_affiliation>
    <investigator_full_name>Bin Cao</investigator_full_name>
    <investigator_title>China-Japan Friendship Hospital</investigator_title>
  </responsible_party>
  <keyword>severe influenza, arbidol, oseltamivir, ordinal scale</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Dear Sir/Madam Our study receives a grant from China Ministry of Science and Technology. We cannot decide whether the data could be shared. Hope you can understand.&#xD;
Best</ipd_description>
  </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/NCT03787459
org study id: CAP-China Arbidol
nct id: NCT03787459
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a multicenter, randomised, double-blind, controlled study to assess the efficacy and
      safety of arbidol plus oseltamivir, compared with oseltamivir alone in approximately 200
      hospitalized adults and adolescent patients with confirmed severe influenza. Patients should
      be randomised as soon as possible after screening (no later than 12 hours), providing they
      are within 7 days of symptom onset. Patients will be assigned in a 1:1 ratio to receive an
      arbidol plus oseltamivir, or oseltamivir plus placebo. Rescreening of patients who fail to
      meet the inclusion and exclusion criteria will be permitted only once, providing the time
      from symptom onset to randomization is still within 7 days.

      Arbidol/placebo will be administrated as 200mg TID from Days 1-7. Oseltamivir will be
      administered as 75mg twice daily from Days 1-7 (dose to be adjusted for renal impairment).
      Oseltamivir could be continued till influenza PCR negative. Both drugs, along with the
      corresponding placebo for arbidol, will be started at the time of randomization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The primary efficacy endpoint was time to clinical status improvement (the event) up to 28 days
time frame: 28 days
description: the event defined as seven-category ordinal scale of clinical status after enrolment decrease by two category or discharged
arm group label: oseltamivir plus placebo
arm group type: Active Comparator
arm group label: oseltamivir plus arbidol
arm group type: Experimental
intervention type: Drug
intervention name: Arbidol
description: Oseltamivir plus Arbidol will be administrated from Days 1-7.
arm group label: oseltamivir plus arbidol
intervention type: Drug
intervention name: Placebos
description: Oseltamivir plus placebos will be administrated from Days 1-7.
arm group label: oseltamivir plus placebo
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Capital Medical University
investigator full name: Bin Cao
investigator title: China-Japan Friendship Hospital
mesh term: Influenza, Human
sharing ipd: Undecided
ipd description: Dear Sir/Madam Our study receives a grant from China Ministry of Science and Technology. We cannot decide whether the data could be shared. Hope you can understand.
Best