<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/NCT04459676</url>
  </required_header>
  <id_info>
    <org_study_id>ANG3777-ALI-201</org_study_id>
    <nct_id>NCT04459676</nct_id>
  </id_info>
  <brief_title>Study to Assess Efficacy and Safety Relative to Standard of Care in Patients With COVID-19 Pneumonia</brief_title>
  <official_title>A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess Safety and Efficacy of ANG- 3777 in Patients Hospitalized With Confirmed COVID-19 Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Angion Biomedica Corp</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CTI Clinical Trial and Consulting Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Angion Biomedica Corp</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the clinical efficacy of ANG-3777 relative to the standard of care in reducing the&#xD;
      severity and progression of pulmonary and renal dysfunction and mortality in adult patients&#xD;
      hospitalized with COVID-19 pneumonia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 31, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2021</primary_completion_date>
  <phase>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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients alive, without the need for mechanical ventilation and free of the need for RRT (on an ongoing basis) at Day 28</measure>
    <time_frame>From the time of randomization until (Day 1) until death or until Day28, whichever comes first</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>COVID-19</condition>
  <condition>Pneumonia</condition>
  <arm_group>
    <arm_group_label>ANG-3777 + SOC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ANG-3777 Administered IV for 30 min and SOC&#xD;
Repeat within 24 hours after previous dosing for a total of 4 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care + Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard of Care + Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard of Care (SOC) + ANG-3777</intervention_name>
    <description>Standard of Care (SOC) + ANG-3777</description>
    <arm_group_label>ANG-3777 + SOC</arm_group_label>
    <other_name>BB3</other_name>
    <other_name>Hepatocyte growth factor mimetic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard Of Care (SOC) + Placebo</intervention_name>
    <description>Standard Of Care + Placebo</description>
    <arm_group_label>Standard of Care + Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is a male or nonpregnant female 18 years of age or older.&#xD;
&#xD;
          2. Patient has a positive reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay&#xD;
             for SARS-CoV-2 in a respiratory tract sample during the current hospital admission.&#xD;
&#xD;
          3. Patient has pneumonia confirmed by chest imaging.&#xD;
&#xD;
          4. Patient has moderate to severe disease based on the WHO disease severity scale&#xD;
             assessment at the time of randomization defined as:&#xD;
&#xD;
               -  Score 4, only those with FiO2 &gt; 40%&#xD;
&#xD;
               -  Score 5 (Non-invasive ventilation or high-flow oxygen)&#xD;
&#xD;
          5. Patient has ability to provide informed consent signed by study patient or legally&#xD;
             acceptable representative.&#xD;
&#xD;
          6. Patient has willingness and ability to comply with study-related&#xD;
             procedures/assessments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has an active malignancy or history of solid or hematological malignancies within 5&#xD;
             years prior to enrollment in the study. Patients who had basal or squamous cell&#xD;
             carcinoma-in-situ of the skin that was diagnosed &gt; 2 years prior to the study&#xD;
             enrollment and not currently being treated are eligible for study enrollment.&#xD;
&#xD;
          2. Patient is pregnant or breast-feeding.&#xD;
&#xD;
          3. Patient, in the opinion of the investigator, is unlikely to survive for ≥48 hours from&#xD;
             the time of screening.&#xD;
&#xD;
          4. Patient has any physical examination findings and/or history of any illness that, in&#xD;
             the opinion of the study investigator, might confound the results of the study or pose&#xD;
             an additional risk to the patient by their participation in the study.&#xD;
&#xD;
          5. Patient with alanine aminotransferase (ALT) or aspartate transaminase (AST) &gt; 3x upper&#xD;
             limit of normal (ULN) and/or total bilirubin &gt; 2xULN at baseline&#xD;
&#xD;
          6. Patient requires treatment with the cytochrome P450 1A2 (CYP1A2) inhibitors,&#xD;
             ciprofloxacin (Cipro®) and/or fluvoxamine (Luvox®)&#xD;
&#xD;
          7. Patients participating in any other clinical trial with an investigational drug&#xD;
             product or procedure&#xD;
&#xD;
          8. Recipients of solid organ and/or hematopoietic cell transplantation&#xD;
&#xD;
          9. Patient is known to have End Stage Renal Disease (ESRD) and was being treated with&#xD;
             maintenance hemodialysis or peritoneal dialysis prior to the current hospitalization.&#xD;
&#xD;
        Note: Patients who initiated RRT due to Acute Kidney Injury during their current&#xD;
        hospitalization will be eligible for the study&#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_official>
    <last_name>John Neylan, MD</last_name>
    <role>Study Director</role>
    <affiliation>Angion Biomedica</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Vera Cruz - NUPEC Nucleo de Pesquisa Clínica</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Casa de Misericórdia de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pontifícia Universidade Catolica de Campinas</name>
      <address>
        <city>Campinas</city>
        <state>Sao Paulo</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPCLIN - Faculdade de Medicina da UNESP Campus de Botucatu</name>
      <address>
        <city>Botucatu</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP)</name>
      <address>
        <city>Ribeirão Preto</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Vila Nova Star</name>
      <address>
        <city>Sao Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irmandade da Santa Casa de Misericórdia de São</name>
      <address>
        <city>Sao Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Alemao Oswaldo Cruz</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Heliópolis-SP</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Casa de Misericordia de Sao Paulo</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>April 12, 2021</last_update_submitted>
  <last_update_submitted_qc>April 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Acute Lung Injury</keyword>
  <keyword>Acute Respiratory Distress Syndrome</keyword>
  <keyword>Pneumonia</keyword>
  <keyword>Respiratory Failure</keyword>
  <keyword>AKI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitogens</mesh_term>
  </intervention_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/NCT04459676
org study id: ANG3777-ALI-201
nct id: NCT04459676
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
To assess the clinical efficacy of ANG-3777 relative to the standard of care in reducing the
      severity and progression of pulmonary and renal dysfunction and mortality in adult patients
      hospitalized with COVID-19 pneumonia
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Proportion of patients alive, without the need for mechanical ventilation and free of the need for RRT (on an ongoing basis) at Day 28
time frame: From the time of randomization until (Day 1) until death or until Day28, whichever comes first
arm group label: ANG-3777 + SOC
arm group type: Active Comparator
description: ANG-3777 Administered IV for 30 min and SOC
Repeat within 24 hours after previous dosing for a total of 4 days
arm group label: Standard of Care + Placebo
arm group type: Placebo Comparator
description: Standard of Care + Placebo
intervention type: Drug
intervention name: Standard of Care (SOC) + ANG-3777
description: Standard of Care (SOC) + ANG-3777
arm group label: ANG-3777 + SOC
other name: BB3
other name: Hepatocyte growth factor mimetic
intervention type: Drug
intervention name: Standard Of Care (SOC) + Placebo
description: Standard Of Care + Placebo
arm group label: Standard of Care + Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John Neylan, MD
role: Study Director
affiliation: Angion Biomedica
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Mitogens