<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/NCT04464395</url>
  </required_header>
  <id_info>
    <org_study_id>CPI-006-002</org_study_id>
    <nct_id>NCT04464395</nct_id>
  </id_info>
  <brief_title>Study of CPI-006 as Immunotherapy for Hospitalized COVID-19 Patients</brief_title>
  <official_title>Immunotherapy of COVID-19 With B-Cell Activating CPI-006 Monoclonal Antibody</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corvus Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corvus Pharmaceuticals, Inc.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Phase 1 single-dose, dose-escalation study is an open label trial evaluating the safety&#xD;
      of CPI-006, a humanized monoclonal antibody targeting the CD73 cell-surface ectonucleotidase,&#xD;
      as immunotherapy for stable hospitalized mild or moderately symptomatic COVID-19 patients&#xD;
      with a parallel non-randomized Control Arm for treatment with standard of care only.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">July 9, 2021</completion_date>
  <primary_completion_date type="Actual">March 1, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events to Determine Single Dose of CPI-006 That is Safe in Patients with COVID-19</measure>
    <time_frame>Up to 30 days after dose of CPI-006.</time_frame>
    <description>Incidence of adverse events (including serious adverse events and dose limiting toxicities).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immunoglobulin Anti-SARS CoV-2 Levels</measure>
    <time_frame>Baseline and Day 28.</time_frame>
    <description>Measure changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Negative Nasal Swab Polymerase Chain Reaction (PCR) SARS CoV-2 Viral Tests</measure>
    <time_frame>Baseline to two consecutive negative nasal swab PCR SARS CoV-2 viral tests (separated by at least 48 hours).</time_frame>
    <description>Time to two consecutive negative nasal swab PCR SARS CoV-2 viral tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of symptoms</measure>
    <time_frame>Up to 24 weeks after dose of CPI-006.</time_frame>
    <description>Duration of COVID-19 related symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to discharge</measure>
    <time_frame>Up to 24 weeks after dose of CPI-006.</time_frame>
    <description>Time to discharge from hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of medical procedures</measure>
    <time_frame>Up to 24 weeks after dose of CPI-006.</time_frame>
    <description>Rate of medical procedures during hospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in changes in serum/plasma immunoglobulin anti-SARS CoV-2 levels</measure>
    <time_frame>Baseline and visits through Day 28.</time_frame>
    <description>Difference between Active Arm and Control Arm patients in terms of changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>CPI-006 Dose Escalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CPI-006 + Standard of Care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard of Care Only</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CPI-006</intervention_name>
    <description>Participants will receive a single dose of CPI-006 at one of four dose levels (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, or 5.0 mg/kg) along with standard of care.</description>
    <arm_group_label>CPI-006 Dose Escalation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Participants will receive standard of care treatment only.</description>
    <arm_group_label>Control Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nasal swab test positive by reverse transcriptase PCR for SARS CoV-2 within past 7&#xD;
             days, and onset of COVID-19 symptoms no more than 10 days prior to the positive test&#xD;
&#xD;
          -  Hospitalized and have stable mild to moderate symptoms of COVID-19&#xD;
&#xD;
          -  Blood oxygen saturation of a minimum of 92% on either no oxygen or up to 5L/min&#xD;
             supplemental oxygen&#xD;
&#xD;
          -  Patients with cancer must be in remission or have stable, controlled disease and may&#xD;
             be actively receiving drugs or biologics not deemed by the investigator to likely&#xD;
             affect immune response.&#xD;
&#xD;
          -  Women must not be of child bearing potential or agree to use contraceptive guidance&#xD;
             for 6 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients receiving previous invasive mechanical ventilation or non-invasive&#xD;
             ventilation (CPAP, BiPAP) for COVID-19 illness&#xD;
&#xD;
          -  Patients hospitalized &gt;7 days prior to receiving study intervention&#xD;
&#xD;
          -  Other diseases or conditions that are not controlled&#xD;
&#xD;
          -  On drugs or biologics that are immunosuppressive, cytotoxic or immunomodulatory&#xD;
&#xD;
          -  Patients with autoimmune disease must be controlled on non immunosuppressive or immune&#xD;
             modifying agents&#xD;
&#xD;
          -  Have received cytotoxic, immunosuppressive or immunomodulatory agents within past 3&#xD;
             months (other than for treatment of COVID-19).&#xD;
&#xD;
          -  Patients receiving experimental therapies that are immunosuppressive&#xD;
&#xD;
          -  Patients receiving non-immuno-suppressive experimental therapies within 7 days prior&#xD;
             to receiving CPI-006&#xD;
&#xD;
          -  Patients receiving convalescent plasma within 24 hours prior to receiving CPI-006&#xD;
&#xD;
          -  Patients receiving experimental anti-SARS CoV-2 monoclonal antibodies within past 30&#xD;
             days&#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>S. Mahabhashyam, MD. MPH</last_name>
    <role>Study Chair</role>
    <affiliation>Corvus Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>El Centro Regional Medical Center</name>
      <address>
        <city>El Centro</city>
        <state>California</state>
        <zip>92243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 20, 2021</last_update_submitted>
  <last_update_submitted_qc>July 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS CoV-2</keyword>
  <keyword>Coronavirus</keyword>
  <keyword>Covid</keyword>
  <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/NCT04464395
org study id: CPI-006-002
nct id: NCT04464395
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This Phase 1 single-dose, dose-escalation study is an open label trial evaluating the safety
      of CPI-006, a humanized monoclonal antibody targeting the CD73 cell-surface ectonucleotidase,
      as immunotherapy for stable hospitalized mild or moderately symptomatic COVID-19 patients
      with a parallel non-randomized Control Arm for treatment with standard of care only.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Treatment-Emergent Adverse Events to Determine Single Dose of CPI-006 That is Safe in Patients with COVID-19
time frame: Up to 30 days after dose of CPI-006.
description: Incidence of adverse events (including serious adverse events and dose limiting toxicities).
measure: Immunoglobulin Anti-SARS CoV-2 Levels
time frame: Baseline and Day 28.
description: Measure changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.
measure: Negative Nasal Swab Polymerase Chain Reaction (PCR) SARS CoV-2 Viral Tests
time frame: Baseline to two consecutive negative nasal swab PCR SARS CoV-2 viral tests (separated by at least 48 hours).
description: Time to two consecutive negative nasal swab PCR SARS CoV-2 viral tests.
measure: Duration of symptoms
time frame: Up to 24 weeks after dose of CPI-006.
description: Duration of COVID-19 related symptoms.
measure: Time to discharge
time frame: Up to 24 weeks after dose of CPI-006.
description: Time to discharge from hospital.
measure: Rate of medical procedures
time frame: Up to 24 weeks after dose of CPI-006.
description: Rate of medical procedures during hospitalization.
measure: Difference in changes in serum/plasma immunoglobulin anti-SARS CoV-2 levels
time frame: Baseline and visits through Day 28.
description: Difference between Active Arm and Control Arm patients in terms of changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.
arm group label: CPI-006 Dose Escalation
arm group type: Experimental
description: CPI-006 + Standard of Care
arm group label: Control Arm
arm group type: Other
description: Standard of Care Only
intervention type: Drug
intervention name: CPI-006
description: Participants will receive a single dose of CPI-006 at one of four dose levels (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, or 5.0 mg/kg) along with standard of care.
arm group label: CPI-006 Dose Escalation
intervention type: Other
intervention name: Standard of Care
description: Participants will receive standard of care treatment only.
arm group label: Control Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: S. Mahabhashyam, MD. MPH
role: Study Chair
affiliation: Corvus Pharmaceuticals
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19