<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/NCT04462848</url>
  </required_header>
  <id_info>
    <org_study_id>IRB#20-001263</org_study_id>
    <nct_id>NCT04462848</nct_id>
  </id_info>
  <brief_title>Covid-19 Convalescent Plasma as Prevention and Treatment for Children With Underlying Medical Conditions</brief_title>
  <official_title>Phase I Study of the Safety and Pharmacokinetics of Human Convalescent Plasma in High Risk Children Exposed or Infected With SARS-CoV-2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</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 study will provide access to investigational anti-SARS-CoV-2 human convalescent plasma&#xD;
      for pediatric patients with underlying medical conditions (cardiovascular disease, lung&#xD;
      disease, immunosuppression) who are either infected with SARS-CoV-2 or who have had a&#xD;
      high-risk exposure. Study participants will be transfused once with compatible convalescent&#xD;
      plasma obtained from an individual who has recovered from documented infection with&#xD;
      SARS-CoV-2. Safety information and pharmacokinetic data will be collected.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative incidence of Grade 3 and Grade 4 adverse events</measure>
    <time_frame>up to Day 28 post-administration of study plasma</time_frame>
    <description>A Grade 3 adverse event is any untoward or unfavorable medical occurrence in which symptoms are severe and cause inability to perform usual social and functional activities with medical intervention or therapy indicated.&#xD;
A Grade 4 adverse event is any untoward or unfavorable medical occurrence in which potentially life-threatening symptoms cause inability to perform basic self-care functions with medical intervention or therapy indicated to prevent permanent impairment, persistent disability, or death.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative incidence of serious adverse events</measure>
    <time_frame>up to Day 28 post-administration of study plasma</time_frame>
    <description>A serious adverse event is any untoward or unfavorable medical occurrence that:&#xD;
results in death,&#xD;
is life-threatening,&#xD;
requires inpatient hospitalization or prolongation of existing hospitalization,&#xD;
results in persistent or significant disability/incapacity&#xD;
is a congenital anomaly/birth defect, or&#xD;
is an important medical event that may or may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with disease worsening event.</measure>
    <time_frame>up to Day 28 post-administration of study plasma</time_frame>
    <description>Descriptive analysis of disease worsening event as represented by hospitalization, prolongation of hospitalization, need for supplemental oxygen, respiratory distress, requirement for mechanical ventilation, and death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum concentration at baseline, Day 7, Day 14, and Day 28 for anti-SARS-CoV-2 antibodies</measure>
    <time_frame>Days 0, 7, 14, and 28</time_frame>
    <description>Anti-SARS-CoV-2 antibody titer changes over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with a natural antibody response to SARS-CoV-2 infection</measure>
    <time_frame>once between Day 60 and Day 120</time_frame>
    <description>This will be assessed by the presence or absence of anti-SARS-CoV-2 antibody titers to be collected once between 60 and 120 days post study plasma administration</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Corona Virus Infection</condition>
  <arm_group>
    <arm_group_label>anti-SARS-CoV-2 human convalescent plasma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single transfusion of human convalescent plasma</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>anti-SARS-CoV-2 human convalescent plasma</intervention_name>
    <description>Single transfusion. The total volume (mL) to be transfused will be based on participant weight (kg) and will be calculated as 5 mL/kg. The maximum volume to be transfused will be 500 mL.</description>
    <arm_group_label>anti-SARS-CoV-2 human convalescent plasma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 1 month and &lt; 18 years at the time of consent.&#xD;
&#xD;
          -  Determined to be at high-risk for severe SARS-CoV-2 disease based on the American&#xD;
             Academy of Pediatrics definition of immunocompromised children and reported high-risk&#xD;
             pediatric subpopulations. These include the following groups: immunocompromised,&#xD;
             hemodynamically significant cardiac disease (e.g. congenital heart disease), lung&#xD;
             disease with chronic respiratory failure, infant, i.e. child ≤1 year old.&#xD;
&#xD;
          -  Confirmed SARS-CoV-2 infection OR high-risk exposure as defined:&#xD;
&#xD;
               -  Confirmed infection: Child who tested positive for COVID-19 and is no more than&#xD;
                  96 hours after onset of symptoms (and within 120 hours at the time of receipt of&#xD;
                  study plasma).&#xD;
&#xD;
               -  High-risk exposure: Susceptible child who was not previously infected or&#xD;
                  otherwise immune to SARS-CoV-2 and exposed within 96 hours prior to enrollment&#xD;
                  (and within 120 hours at the time of receipt of study plasma). Both criteria&#xD;
                  below should be met:&#xD;
&#xD;
                    1. A household member or daycare center (same room) exposure to a person with&#xD;
                       confirmed SARS-CoV-2 OR with clinically compatible disease in areas with&#xD;
                       widespread ongoing transmission&#xD;
&#xD;
                    2. Negative for SARS-CoV-2 (nasopharyngeal or oropharyngeal swab)&#xD;
&#xD;
          -  For females of reproductive potential (defined as having experienced menarche), not&#xD;
             pregnant based on testing performed at screening.&#xD;
&#xD;
          -  Parent or legal guardian able and willing to provide signed parent permission.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of severe reactions (e.g. anaphylaxis) to transfusion of blood products.&#xD;
             Individuals with minor reactions such as fever, itching, chills, etc. that resolve&#xD;
             spontaneously or respond to pre-medications, and that do not represent more&#xD;
             significant allergic reactions, will not be excluded.&#xD;
&#xD;
          -  For females, breastfeeding, or planning to become pregnant/breastfeed during the study&#xD;
             period.&#xD;
&#xD;
          -  Participant is unlikely to adhere to the study procedures, keep appointments, or is&#xD;
             planning to relocate outside the greater Los Angeles area during the study.&#xD;
&#xD;
          -  Any condition that would, in the opinion of the principal investigator, place the&#xD;
             participant at an unacceptable risk of injury or render the participant unable to meet&#xD;
             the requirements of the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jaime G Deville, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCLA Clinical Professor of Pediatrics</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jaime G Deville, M.D.</last_name>
    <phone>310-825-9660</phone>
    <email>jdeville@mednet.ucla.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of California, Los Angeles (UCLA)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Jaime G Deville, M.D.</last_name>
      <phone>310-825-9660</phone>
      <email>jdeville@mednet.ucla.edu</email>
    </contact>
    <contact_backup>
      <last_name>Michele F Carter, R.N.</last_name>
      <phone>310-206-6369</phone>
      <email>mfcarter@mednet.ucla.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Jaime G. Deville, MD, FAAP</investigator_full_name>
    <investigator_title>Clinical Professor of Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04462848
org study id: IRB#20-001263
nct id: NCT04462848
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will provide access to investigational anti-SARS-CoV-2 human convalescent plasma
      for pediatric patients with underlying medical conditions (cardiovascular disease, lung
      disease, immunosuppression) who are either infected with SARS-CoV-2 or who have had a
      high-risk exposure. Study participants will be transfused once with compatible convalescent
      plasma obtained from an individual who has recovered from documented infection with
      SARS-CoV-2. Safety information and pharmacokinetic data will be collected.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cumulative incidence of Grade 3 and Grade 4 adverse events
time frame: up to Day 28 post-administration of study plasma
description: A Grade 3 adverse event is any untoward or unfavorable medical occurrence in which symptoms are severe and cause inability to perform usual social and functional activities with medical intervention or therapy indicated.
A Grade 4 adverse event is any untoward or unfavorable medical occurrence in which potentially life-threatening symptoms cause inability to perform basic self-care functions with medical intervention or therapy indicated to prevent permanent impairment, persistent disability, or death.
measure: Cumulative incidence of serious adverse events
time frame: up to Day 28 post-administration of study plasma
description: A serious adverse event is any untoward or unfavorable medical occurrence that:
results in death,
is life-threatening,
requires inpatient hospitalization or prolongation of existing hospitalization,
results in persistent or significant disability/incapacity
is a congenital anomaly/birth defect, or
is an important medical event that may or may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.
measure: Proportion of participants with disease worsening event.
time frame: up to Day 28 post-administration of study plasma
description: Descriptive analysis of disease worsening event as represented by hospitalization, prolongation of hospitalization, need for supplemental oxygen, respiratory distress, requirement for mechanical ventilation, and death.
measure: Serum concentration at baseline, Day 7, Day 14, and Day 28 for anti-SARS-CoV-2 antibodies
time frame: Days 0, 7, 14, and 28
description: Anti-SARS-CoV-2 antibody titer changes over time
measure: Percentage of participants with a natural antibody response to SARS-CoV-2 infection
time frame: once between Day 60 and Day 120
description: This will be assessed by the presence or absence of anti-SARS-CoV-2 antibody titers to be collected once between 60 and 120 days post study plasma administration
arm group label: anti-SARS-CoV-2 human convalescent plasma
arm group type: Experimental
description: single transfusion of human convalescent plasma
intervention type: Biological
intervention name: anti-SARS-CoV-2 human convalescent plasma
description: Single transfusion. The total volume (mL) to be transfused will be based on participant weight (kg) and will be calculated as 5 mL/kg. The maximum volume to be transfused will be 500 mL.
arm group label: anti-SARS-CoV-2 human convalescent plasma
criteria: 
gender: All
minimum age: 1 Month
maximum age: 17 Years
healthy volunteers: No
last name: Jaime G Deville, M.D.
role: Principal Investigator
affiliation: UCLA Clinical Professor of Pediatrics
last name: Jaime G Deville, M.D.
phone: 310-825-9660
email: jdeville@mednet.ucla.edu
facility: 
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Jaime G. Deville, MD, FAAP
investigator title: Clinical Professor of Pediatrics
mesh term: Coronavirus Infections
sharing ipd: No