<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/NCT04433013</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-2020-05-029</org_study_id>
    <nct_id>NCT04433013</nct_id>
  </id_info>
  <brief_title>A Randomized Controlled Trial Assessing the Efficacy of Lianhua Qingwen as an Adjuvant Treatment in Patients With Mild Symptoms of COVID-19</brief_title>
  <official_title>A Randomized Controlled Trial Assessing the Efficacy of Lianhua Qingwen as an Adjuvant Treatment in Patients With Mild Symptoms of COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanyang Technological University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nanyang Technological University</source>
  <oversight_info>
    <has_dmc>No</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>
      COVID-19 virus remains in infected patients for extended periods of time. A great resource&#xD;
      burden is placed on the healthcare system and society at large to isolate COVID-19 patients&#xD;
      for prolonged periods. Thus, being able to increase the rate of viral clearance, thus&#xD;
      reducing the duration of COVID-19 infection, would allow patients to be discharged earlier to&#xD;
      free up resources for those who require it. The investigators designed a randomized&#xD;
      controlled trial, investigating the use of Lianhua Qingwen, a TCM treatment, in COVID-19&#xD;
      infected patients with mild symptoms. The investigators hypothesize that the use of Lianhua&#xD;
      Qingwen will increase the proportion of patients who test negative for COVID-19 after 8 days&#xD;
      of TCM treatment when compared to the group of patients provided with standard care and&#xD;
      placebo. Patients will be recruited from community isolation facilities, and have onset of&#xD;
      symptoms within 5 days prior to admission to the isolation facility. The trial also evaluates&#xD;
      the time taken for relief of clinical symptoms associated with COVID-19 and assesses the&#xD;
      safety of the TCM treatment given to patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unable to find suitable site Principal Investigator. This study did not start and was withdrawn&#xD;
    as of Aug 2020 (have updated as of Sept 2020, please proceed to update the status of study&#xD;
    withdrawal accordingly)&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">December 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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of participants who test negative for COVID-19</measure>
    <time_frame>after 8 days of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time taken in days for relief of clinical symptoms</measure>
    <time_frame>during the 8-day course of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with mild symptoms of COVID-19 progressing to moderate or severe illness</measure>
    <time_frame>after 8 days of treatment and at the end of the trial</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants who test positive for COVID-19 with Ct value&gt;30</measure>
    <time_frame>after 8 days of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lianhua Qingwen</intervention_name>
    <description>The LHQW capsules will be administered to trial participants 4 capsules, 3 times a day, after meal</description>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The placebo capsules will be administered to trial participants 4 capsules, 3 times a day, after meal</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥21 years&#xD;
&#xD;
          2. Positive laboratory test for COVID-19 by RT-PCR methods&#xD;
&#xD;
          3. Presenting with at least one symptom (symptoms include fever, dry cough, sore throat,&#xD;
             nasal congestion, malaise, headache, muscle pain, anosmia, and diarrhoea)&#xD;
&#xD;
          4. Length of time between date of onset of symptoms and the date of recruitment should&#xD;
             not exceed 5 days to ensure that trial participants are in the early stages of&#xD;
             infection&#xD;
&#xD;
          5. No clinical or radiographic evidence of pneumonia&#xD;
&#xD;
          6. Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Individuals with underlying primary diseases such as cardiovascular, respiratory,&#xD;
             liver, renal, diabetes, hepatitis A/B/C, gout or endocrinological diseases and&#xD;
             neurological disorders which put them at a higher risk of developing severe disease&#xD;
&#xD;
          2. Individuals with compromised immune systems such as malignant tumors, organ or bone&#xD;
             marrow transplants, HIV, or have taken immunosuppressants in the past three months.&#xD;
&#xD;
          3. Women who are pregnant or on lactation.&#xD;
&#xD;
          4. Individuals with mental illness.&#xD;
&#xD;
          5. History of allergy to any drug or food, or herb ingredient observed in this trial.&#xD;
&#xD;
          6. Individuals who are deemed not able to comply with trial procedure or follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yan Zhao</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nanyang Technological University</affiliation>
  </overall_official>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>November 22, 2021</last_update_submitted>
  <last_update_submitted_qc>November 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanyang Technological University</investigator_affiliation>
    <investigator_full_name>Zhao Yan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Traditional Chinese Medicine</keyword>
  <keyword>Randomized Controlled Trial</keyword>
  <keyword>Lianhua Qingwen</keyword>
  <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>


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/NCT04433013
org study id: IRB-2020-05-029
nct id: NCT04433013
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
COVID-19 virus remains in infected patients for extended periods of time. A great resource
      burden is placed on the healthcare system and society at large to isolate COVID-19 patients
      for prolonged periods. Thus, being able to increase the rate of viral clearance, thus
      reducing the duration of COVID-19 infection, would allow patients to be discharged earlier to
      free up resources for those who require it. The investigators designed a randomized
      controlled trial, investigating the use of Lianhua Qingwen, a TCM treatment, in COVID-19
      infected patients with mild symptoms. The investigators hypothesize that the use of Lianhua
      Qingwen will increase the proportion of patients who test negative for COVID-19 after 8 days
      of TCM treatment when compared to the group of patients provided with standard care and
      placebo. Patients will be recruited from community isolation facilities, and have onset of
      symptoms within 5 days prior to admission to the isolation facility. The trial also evaluates
      the time taken for relief of clinical symptoms associated with COVID-19 and assesses the
      safety of the TCM treatment given to patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Proportion of participants who test negative for COVID-19
time frame: after 8 days of treatment
measure: Time taken in days for relief of clinical symptoms
time frame: during the 8-day course of treatment
measure: Proportion of participants with mild symptoms of COVID-19 progressing to moderate or severe illness
time frame: after 8 days of treatment and at the end of the trial
measure: Proportion of participants who test positive for COVID-19 with Ct value>30
time frame: after 8 days of treatment
arm group label: Treatment group
arm group type: Experimental
arm group label: Control group
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Lianhua Qingwen
description: The LHQW capsules will be administered to trial participants 4 capsules, 3 times a day, after meal
arm group label: Treatment group
intervention type: Drug
intervention name: Placebo
description: The placebo capsules will be administered to trial participants 4 capsules, 3 times a day, after meal
arm group label: Control group
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Yan Zhao
role: Principal Investigator
affiliation: Nanyang Technological University
responsible party type: Principal Investigator
investigator affiliation: Nanyang Technological University
investigator full name: Zhao Yan
investigator title: Principal Investigator
mesh term: COVID-19
sharing ipd: No