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/NCT06039449</url>
    </required_header>
    <id_info>
      <org_study_id>VYD222-PREV-001</org_study_id>
      <nct_id>NCT06039449</nct_id>
    </id_info>
    <brief_title>A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2</brief_title>
    <official_title>A Study to Evaluate the Efficacy and Safety of VYD222 for Prevention of COVID-19 (CANOPY)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Invivyd, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Invivyd, 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>
        A study to investigate the prevention of COVID-19 with VYD222 in adults with immune&#xD;
        compromise and in participants aged 12 years or older who are at risk of exposure to&#xD;
        SARS-CoV-2&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 8, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Only applies to Cohort B</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Cohort A - Incidence of treatment emergent adverse events</measure>
      <time_frame>Through Month 12</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort A - Ratio of SARS-CoV-2 sVNA titer against a relevant variant following VYD222 administration at Day 28 compared to a prespecified SARS-CoV-2 sVNA titer threshold.</measure>
      <time_frame>Day 28</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cohort B - Incidence of treatment emergent adverse events</measure>
      <time_frame>Through Month 12</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cohort A - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration at Day 28 above a prespecified SARS-CoV-2 sVNA titer threshold.</measure>
      <time_frame>Day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohort A - sVNA titer by timepoint following VYD222 administration</measure>
      <time_frame>Through Month 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohort A - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration above a minimum SARS-CoV-2 sVNA threshold by timepoint</measure>
      <time_frame>Through Month 12</time_frame>
      <description>The minimum SARS-CoV-2 sVNA titer threshold will be prespecified prior to analysis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohort A - ADAs against VYD222</measure>
      <time_frame>Through Month 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohort A - Serum concentrations (PK) of VYD222</measure>
      <time_frame>Through Month 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohort A - Proportion of participants with RT-PCR-confirmed symptomatic COVID-19</measure>
      <time_frame>Through Month 12</time_frame>
      <description>RT-PCR-confirmed symptomatic COVID-19 is defined as RT-PCR-confirmed SARS-CoV-2 with an onset of symptoms occurring no more than 14 days from the date of the positive RT-PCR test sample collection, COVID-19-related hospitalization, or all-cause death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohort B - Ratio of SARS-CoV-2 sVNA titer against a relevant variant following VYD222 administration at Day 28 compared to a prespecified SARS-CoV-2 sVNA titer threshold.</measure>
      <time_frame>Day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohort B - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration at Day 28 above a prespecified SARS-CoV-2 sVNA titer threshold.</measure>
      <time_frame>Day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohort B - sVNA titer by timepoint following VYD222 administration</measure>
      <time_frame>Through Month 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohort B - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration above a minimum SARS-CoV-2 sVNA threshold by timepoint</measure>
      <time_frame>Through Month 12</time_frame>
      <description>The minimum SARS-CoV-2 sVNA titer threshold will be prespecified prior to analysis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohort B - Proportion of participants with RT-PCR-confirmed symptomatic COVID-19</measure>
      <time_frame>Through Month 12</time_frame>
      <description>RT-PCR-confirmed symptomatic COVID-19 is defined as RT-PCR-confirmed SARS-CoV-2 with an onset of symptoms occurring no more than 14 days from the date of the positive RT-PCR test sample collection, COVID-19-related hospitalization, or all-cause death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohort B - COVID-19-related hospitalization or COVID-19-related death within 28 days of symptom onset</measure>
      <time_frame>Through Month 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohort B - COVID-19-related death</measure>
      <time_frame>Through Month 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohort B - Serum concentrations (PK) of VYD222</measure>
      <time_frame>Through Month 12</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohort B - ADAs against VYD222</measure>
      <time_frame>Through Month 12</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">750</enrollment>
    <condition>COVID-19</condition>
    <condition>SARS-CoV-2</condition>
    <arm_group>
      <arm_group_label>Cohort A VYD222</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort B VYD222</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort B Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>VYD222</intervention_name>
      <description>Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222.</description>
      <arm_group_label>Cohort A VYD222</arm_group_label>
      <arm_group_label>Cohort B VYD222</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Normal saline</intervention_name>
      <description>Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with Placebo.</description>
      <arm_group_label>Cohort B Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Is an adult aged ≥18 years or an adolescent aged 12 to &lt;18 years and weighs at least&#xD;
               40 kg at the time of Screening.&#xD;
  &#xD;
            -  Tests negative for current SARS-CoV-2 infection by local antigen test or RT-PCR at the&#xD;
               time of Screening.&#xD;
  &#xD;
            -  For Cohort A, has significant immune compromise from causes including solid tumor or&#xD;
               hematologic malignancies, chimeric antigen receptor (CAR)-T-cell therapy or&#xD;
               hematopoietic stem cell transplant, primary immunodeficiency, advanced HIV infection,&#xD;
               or receiving qualifying immunosuppressive therapies.&#xD;
  &#xD;
            -  For Cohort B, is at risk of acquiring SARS-CoV-2 due to regular unmasked face-to-face&#xD;
               interactions in indoor settings.&#xD;
  &#xD;
            -  Agrees to defer receipt of any COVID-19 vaccination or booster for a minimum of 28&#xD;
               days after dosing.&#xD;
  &#xD;
            -  Note: unless specified by Cohort, the criteria apply to both Cohorts&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  For Cohort B: Prior receipt of a COVID-19 vaccine or booster within 120 days before&#xD;
               randomization.&#xD;
  &#xD;
            -  Prior receipt of convalescent plasma or a mAb to SARS-CoV-2 active against currently&#xD;
               circulating variants, including in the setting of a clinical trial, within 120 days&#xD;
               before randomization.&#xD;
  &#xD;
            -  Prior known or suspected SARS-CoV-2 infection within 120 days before randomization.&#xD;
  &#xD;
            -  Exposure to someone with known or suspected SARS-CoV-2 infection in the 5 days before&#xD;
               randomization.&#xD;
  &#xD;
            -  Is acutely ill or has any symptoms suggestive of infection, in the opinion of the&#xD;
               Investigator.&#xD;
  &#xD;
          Note 1: Other protocol defined inclusion/exclusion criteria apply Note 2: Unless specified&#xD;
          by Cohort, the criteria apply to both Cohorts&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Study Inquiry</last_name>
      <phone>+1 781-819-0080</phone>
      <email>ClinicalTrials@invivyd.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>INVIVYD Investigative Site</name>
        <address>
          <city>Culver City</city>
          <state>California</state>
          <zip>90230</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>INVIVYD Investigative Site</name>
        <address>
          <city>Fullerton</city>
          <state>California</state>
          <zip>92835</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>INVIVYD Investigative Site</name>
        <address>
          <city>Long Beach</city>
          <state>California</state>
          <zip>90806</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>INVIVYD Investigative Site</name>
        <address>
          <city>Rolling Hills Estates</city>
          <state>California</state>
          <zip>90274</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>INVIVYD Investigative Site</name>
        <address>
          <city>San Diego</city>
          <state>California</state>
          <zip>92103</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>INVIVYD Investigative Site</name>
        <address>
          <city>Clearwater</city>
          <state>Florida</state>
          <zip>33756</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>INVIVYD Investigative Site</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33186</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>INVIVYD Investigative Site</name>
        <address>
          <city>Saint Petersburg</city>
          <state>Florida</state>
          <zip>33705</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>INVIVYD Investigative Site</name>
        <address>
          <city>Hinesville</city>
          <state>Georgia</state>
          <zip>31313</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>INVIVYD Investigative Site</name>
        <address>
          <city>Silver Spring</city>
          <state>Maryland</state>
          <zip>20904</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>INVIVYD Investigative Site</name>
        <address>
          <city>Burlington</city>
          <state>Massachusetts</state>
          <zip>01803</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>INVIVYD Investigative Site</name>
        <address>
          <city>Salisbury</city>
          <state>North Carolina</state>
          <zip>28144</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>INVIVYD Investigative Site</name>
        <address>
          <city>Edmond</city>
          <state>Oklahoma</state>
          <zip>73013</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>INVIVYD Investigative Site</name>
        <address>
          <city>Yukon</city>
          <state>Oklahoma</state>
          <zip>73099</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>INVIVYD Investigative Site</name>
        <address>
          <city>Beaumont</city>
          <state>Texas</state>
          <zip>77706</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>INVIVYD Investigative Site</name>
        <address>
          <city>Dallas</city>
          <state>Texas</state>
          <zip>75230</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</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>
    <keyword>Immune Compromise</keyword>
    <keyword>VYD222</keyword>
    <keyword>SARS-CoV-2 Monoclonal Antibody</keyword>
    <keyword>COVID-19 Prevention</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>
  
  
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/NCT06039449
  org study id: VYD222-PREV-001
  nct id: NCT06039449
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  A study to investigate the prevention of COVID-19 with VYD222 in adults with immune
        compromise and in participants aged 12 years or older who are at risk of exposure to
        SARS-CoV-2
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Only applies to Cohort B
  measure: Cohort A - Incidence of treatment emergent adverse events
  time frame: Through Month 12
  measure: Cohort A - Ratio of SARS-CoV-2 sVNA titer against a relevant variant following VYD222 administration at Day 28 compared to a prespecified SARS-CoV-2 sVNA titer threshold.
  time frame: Day 28
  measure: Cohort B - Incidence of treatment emergent adverse events
  time frame: Through Month 12
  measure: Cohort A - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration at Day 28 above a prespecified SARS-CoV-2 sVNA titer threshold.
  time frame: Day 28
  measure: Cohort A - sVNA titer by timepoint following VYD222 administration
  time frame: Through Month 12
  measure: Cohort A - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration above a minimum SARS-CoV-2 sVNA threshold by timepoint
  time frame: Through Month 12
  description: The minimum SARS-CoV-2 sVNA titer threshold will be prespecified prior to analysis.
  measure: Cohort A - ADAs against VYD222
  time frame: Through Month 12
  measure: Cohort A - Serum concentrations (PK) of VYD222
  time frame: Through Month 12
  measure: Cohort A - Proportion of participants with RT-PCR-confirmed symptomatic COVID-19
  time frame: Through Month 12
  description: RT-PCR-confirmed symptomatic COVID-19 is defined as RT-PCR-confirmed SARS-CoV-2 with an onset of symptoms occurring no more than 14 days from the date of the positive RT-PCR test sample collection, COVID-19-related hospitalization, or all-cause death.
  measure: Cohort B - Ratio of SARS-CoV-2 sVNA titer against a relevant variant following VYD222 administration at Day 28 compared to a prespecified SARS-CoV-2 sVNA titer threshold.
  time frame: Day 28
  measure: Cohort B - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration at Day 28 above a prespecified SARS-CoV-2 sVNA titer threshold.
  time frame: Day 28
  measure: Cohort B - sVNA titer by timepoint following VYD222 administration
  time frame: Through Month 12
  measure: Cohort B - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration above a minimum SARS-CoV-2 sVNA threshold by timepoint
  time frame: Through Month 12
  description: The minimum SARS-CoV-2 sVNA titer threshold will be prespecified prior to analysis.
  measure: Cohort B - Proportion of participants with RT-PCR-confirmed symptomatic COVID-19
  time frame: Through Month 12
  description: RT-PCR-confirmed symptomatic COVID-19 is defined as RT-PCR-confirmed SARS-CoV-2 with an onset of symptoms occurring no more than 14 days from the date of the positive RT-PCR test sample collection, COVID-19-related hospitalization, or all-cause death.
  measure: Cohort B - COVID-19-related hospitalization or COVID-19-related death within 28 days of symptom onset
  time frame: Through Month 12
  measure: Cohort B - COVID-19-related death
  time frame: Through Month 12
  measure: Cohort B - Serum concentrations (PK) of VYD222
  time frame: Through Month 12
  measure: Cohort B - ADAs against VYD222
  time frame: Through Month 12
  arm group label: Cohort A VYD222
  arm group type: Experimental
  arm group label: Cohort B VYD222
  arm group type: Experimental
  arm group label: Cohort B Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: VYD222
  description: Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222.
  arm group label: Cohort A VYD222
  arm group label: Cohort B VYD222
  intervention type: Drug
  intervention name: Normal saline
  description: Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with Placebo.
  arm group label: Cohort B Placebo
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Study Inquiry
  phone: +1 781-819-0080
  email: ClinicalTrials@invivyd.com
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: COVID-19
  sharing ipd: No