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/NCT06039163</url>
    </required_header>
    <id_info>
      <org_study_id>HH120-103</org_study_id>
      <nct_id>NCT06039163</nct_id>
    </id_info>
    <brief_title>A Study to Assess the Safety, Tolerability and Preliminary Efficacy of HH-120 for the Treatment of COVID-19</brief_title>
    <official_title>A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Assess the Safety, Tolerability, Preliminary Efficacy of Inhaled HH-120 Aerosol in Participants With Mild to Moderate COVID-19</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Huahui Health</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Huahui Health</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>
        This is a randomized, double-blind, placebo-controlled Phase 1 study in participants over the&#xD;
        age of 18 years with mild to moderate COVID-19. This study aims to assess the safety,&#xD;
        tolerability and preliminary antiviral effect of HH-120. This study includes dose escalation&#xD;
        phase and dose expansion phase.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 16, 2022</start_date>
    <completion_date type="Actual">October 10, 2022</completion_date>
    <primary_completion_date type="Actual">October 10, 2022</primary_completion_date>
    <phase>Phase 1</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>Safety and Tolerability: Incidence, frequency, severity, and duration of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAE) and serious adverse events (SAEs), etc.</measure>
      <time_frame>From Baseline to Day 12</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants that achieve SARS-CoV-2 clearance (defined as negative qRT-PCR tests taken on two consecutive days), with the time of clearance being the time of the first negative test.</measure>
      <time_frame>From Baseline to Day 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Median time to achieve SARS-CoV-2 clearance (defined as negative qRT-PCR tests taken on two consecutive days), with the time of clearance being the time of the first negative test.</measure>
      <time_frame>From Baseline to Day 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Median time to sustained clinical recovery.</measure>
      <time_frame>From Baseline to Day 12</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">37</enrollment>
    <condition>COVID-19</condition>
    <arm_group>
      <arm_group_label>HH-120</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>HH-120</intervention_name>
      <description>Participants randomized to active treatment in escalation phase will receive HH-120 administered via inhalation for 5 consecutive days (Day 1 to Day 5). Planned dose levels to be used for the escalation phase of the study are 50 (BID), 50 (TID), and 100 (BID) mg. The expansion phase will begin once the recommended dose for expansion phase determined, based on safety and preliminary efficacy data from the escalation phase.</description>
      <arm_group_label>HH-120</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>placebo</intervention_name>
      <description>Participants randomized to placebo group in escalation and expansion phase will receive placebo administered via inhalation for 5 consecutive days (Day 1 to Day 5).</description>
      <arm_group_label>placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The escalation phase:&#xD;
  &#xD;
                 1. Participants are aged 18 to 65 years (inclusive at the time of informed consent)&#xD;
  &#xD;
                 2. Participants are mild or moderate COVID-19 patients.&#xD;
  &#xD;
                 3. Participants have one or more mild or moderate COVID 19-related symptoms as&#xD;
                    defined by the FDA (see the Diagnosis and Main Criteria for Inclusion) with the&#xD;
                    onset of symptoms ≤ 3 days prior to the randomization.&#xD;
  &#xD;
            -  The expansion phase:&#xD;
  &#xD;
                 1. Participants are ≥18 years of age at the time of randomization.&#xD;
  &#xD;
                 2. Participants are mild or moderate COVID-19 patients.&#xD;
  &#xD;
                 3. Participants have one or more mild or moderate COVID 19-related symptoms as&#xD;
                    defined by the FDA (see the Diagnosis and Main Criteria for Inclusion) with the&#xD;
                    onset of symptoms ≤ 5 days prior to the randomization.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or lactating at Screening or planning to become pregnant (self or partner) at&#xD;
               any time during the study, including the follow-up period.&#xD;
  &#xD;
            -  Prior or ongoing medical conditions, medical history, physical findings, or laboratory&#xD;
               abnormality that, in the PI's (or delegate's) opinion, could adversely affect the&#xD;
               safety of the participant or that might interfere with the conduct of the study.&#xD;
  &#xD;
            -  Presence of any underlying physical or psychological medical condition that, in the&#xD;
               opinion of the PI, would make it unlikely that the participant will comply with the&#xD;
               protocol or complete the study per protocol.&#xD;
  &#xD;
            -  Have known allergies to any of the components used in the formulation of the study&#xD;
               intervention.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Beijing Ditan Hospital,Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100015</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Guangzhou Eighth People's,Guangzhou Medical University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510440</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The First Hospital of Jilin University</name>
        <address>
          <city>Changchun</city>
          <state>Jilin</state>
          <zip>130021</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Huashan Hospital affiliated to Fudan University</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200040</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</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>
    </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/NCT06039163
  org study id: HH120-103
  nct id: NCT06039163
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a randomized, double-blind, placebo-controlled Phase 1 study in participants over the
        age of 18 years with mild to moderate COVID-19. This study aims to assess the safety,
        tolerability and preliminary antiviral effect of HH-120. This study includes dose escalation
        phase and dose expansion phase.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Safety and Tolerability: Incidence, frequency, severity, and duration of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAE) and serious adverse events (SAEs), etc.
  time frame: From Baseline to Day 12
  measure: Proportion of participants that achieve SARS-CoV-2 clearance (defined as negative qRT-PCR tests taken on two consecutive days), with the time of clearance being the time of the first negative test.
  time frame: From Baseline to Day 12
  measure: Median time to achieve SARS-CoV-2 clearance (defined as negative qRT-PCR tests taken on two consecutive days), with the time of clearance being the time of the first negative test.
  time frame: From Baseline to Day 12
  measure: Median time to sustained clinical recovery.
  time frame: From Baseline to Day 12
  arm group label: HH-120
  arm group type: Active Comparator
  arm group label: placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: HH-120
  description: Participants randomized to active treatment in escalation phase will receive HH-120 administered via inhalation for 5 consecutive days (Day 1 to Day 5). Planned dose levels to be used for the escalation phase of the study are 50 (BID), 50 (TID), and 100 (BID) mg. The expansion phase will begin once the recommended dose for expansion phase determined, based on safety and preliminary efficacy data from the escalation phase.
  arm group label: HH-120
  intervention type: Drug
  intervention name: placebo
  description: Participants randomized to placebo group in escalation and expansion phase will receive placebo administered via inhalation for 5 consecutive days (Day 1 to Day 5).
  arm group label: placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  facility: 
  facility: 
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: COVID-19