<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/NCT04432766</url>
  </required_header>
  <id_info>
    <org_study_id>BAT-2020-001-CR</org_study_id>
    <nct_id>NCT04432766</nct_id>
  </id_info>
  <brief_title>A Phase 1/2 Study to Assess Safety and Efficacy of BAT2020 in Hospitalized COVID-19 Patients</brief_title>
  <official_title>A Phase 1/2, Multi-Center, Randomized Study to Assess Safety, Pharmacokinetics, Immunogenicity, and Efficacy of BAT2020 in Hospitalized Patients Infected With SARS-CoV-2 (COVID-19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bio-Thera Solutions</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bio-Thera Solutions</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized study to assess safety, pharmacokinetics, immunogenicity, and efficacy&#xD;
      of BAT2020 in hospitalized patients infected with COVID-19. This study is composed of 2&#xD;
      Parts: a single ascending dose (Part 1) and single dose(s) tested in parallel with a&#xD;
      double-blind, placebo-controlled design (Part 2). Patients also will receive best available&#xD;
      standard of care (SOC) treatment. A data and safety monitoring board (DSMB) will be set up&#xD;
      for the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    strategic decision&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 20, 2020</start_date>
  <completion_date type="Anticipated">August 18, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 20, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse events (AEs)</measure>
    <time_frame>Day 28</time_frame>
    <description>SAE, TEAEs, mortality, those resulting in treatment discontinuation, and changes from baseline in safety laboratory assessments</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Medium dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAT2020</intervention_name>
    <description>After a cohort completes the study on Day 28, data on safety and tolerability for each cohort will be evaluated by the Safety Monitoring Committee (SMC). Administration of the next higher dose to a new dosing cohort will be permitted only if adequate safety and tolerability have been demonstrated. If encouraging clinical benefit is observed at a certain dose level, the study may proceed to a to Part 2 based on emerging data.</description>
    <arm_group_label>High dose</arm_group_label>
    <arm_group_label>Low dose</arm_group_label>
    <arm_group_label>Medium dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        1. Male or nonpregnant female adult ≥18 years of age at time of enrollment.&#xD;
&#xD;
          2. Patient (or legally authorized representative) provides informed consent prior to&#xD;
             initiation of any study procedures.&#xD;
&#xD;
          3. Agrees to the collection of nasopharyngeal swabs for virology assessment.&#xD;
&#xD;
          4. Women of childbearing potential must agree to either abstinence or use at least 1&#xD;
             primary form of contraception at the time of screening and for 4 months after study&#xD;
             drug dosing.&#xD;
&#xD;
          5. Enrollment within 72 hours of hospital admission.&#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>Snake River Research</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>August 6, 2021</last_update_submitted>
  <last_update_submitted_qc>August 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2021</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>


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/NCT04432766
org study id: BAT-2020-001-CR
nct id: NCT04432766
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a randomized study to assess safety, pharmacokinetics, immunogenicity, and efficacy
      of BAT2020 in hospitalized patients infected with COVID-19. This study is composed of 2
      Parts: a single ascending dose (Part 1) and single dose(s) tested in parallel with a
      double-blind, placebo-controlled design (Part 2). Patients also will receive best available
      standard of care (SOC) treatment. A data and safety monitoring board (DSMB) will be set up
      for the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Incidence of adverse events (AEs)
time frame: Day 28
description: SAE, TEAEs, mortality, those resulting in treatment discontinuation, and changes from baseline in safety laboratory assessments
arm group label: Low dose
arm group type: Experimental
arm group label: Medium dose
arm group type: Experimental
arm group label: High dose
arm group type: Experimental
intervention type: Drug
intervention name: BAT2020
description: After a cohort completes the study on Day 28, data on safety and tolerability for each cohort will be evaluated by the Safety Monitoring Committee (SMC). Administration of the next higher dose to a new dosing cohort will be permitted only if adequate safety and tolerability have been demonstrated. If encouraging clinical benefit is observed at a certain dose level, the study may proceed to a to Part 2 based on emerging data.
arm group label: High dose
arm group label: Low dose
arm group label: Medium dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19