<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/NCT04458363</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000789</org_study_id>
    <nct_id>NCT04458363</nct_id>
  </id_info>
  <brief_title>Convalescent Plasma in Pediatric COVID-19</brief_title>
  <official_title>Convalescent Plasma to Optimize Treatment of COVID-19 Disease in Pediatric Patients: A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</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>
      COVID-19 is increasingly affecting children but convalescent plasma (CP) has not been&#xD;
      adequately studied in children to date. The study will determine safety of convalescent&#xD;
      plasma for pediatric patients with severe, or at high risk for severe, COVID-19 disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID19 is an emerging infection with no current approved treatment or prevention. COVID-19&#xD;
      is increasingly affecting children but convalescent plasma (CP) has not been adequately&#xD;
      studied in children to date. The study will determine safety of convalescent plasma for&#xD;
      pediatric patients with severe, or at high risk for severe, COVID-19 disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 4, 2020</start_date>
  <completion_date type="Actual">September 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</primary_completion_date>
  <phase>Early 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>Number of grade 3-5 adverse events that are possible, probably or definitely related to the convalescent plasma (CP) infusion</measure>
    <time_frame>28 days</time_frame>
    <description>Safety of convalescent plasma for pediatric patients will be determined by capturing the grade 3-5 adverse events that are possible, probably or definitely related to the CP infusion, defined using the NCI Common Terminology Criteria for Adverse Events (CTCAE)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in percent of supplemental oxygen</measure>
    <time_frame>Baseline, 72 hours after infusion</time_frame>
    <description>Change in percent of supplemental oxygen within 72 hours after infusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients that required change in level of respiratory support</measure>
    <time_frame>Baseline, 72 hours after infusion</time_frame>
    <description>Number of patients that required change in level of respiratory support such as nasal canula, non-invasive ventilation, mechanical ventilation, high frequency oscillator ventilation, and extracorporeal membrane oxygenation (ECMO)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Number of deaths</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean length of ICU stay (days)</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Length of ICU stay (days) will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean length of hospital stay (days)</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Length of hospital stay (days) will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean length of ventilation (days)</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Length of ventilation (days) will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with progression to renal dysfunction and/or multisystem organ failure</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Number of patients with progression to renal dysfunction and/or multisystem organ failure will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-6 level</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Cytokine milieu will be assayed by Luminex</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of anti-SARS CoV 2 specific T cells</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Cellular studies will be used for evaluation of anti-SARS CoV 2 specific T cells</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diversity of circulating T cells</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Cellular studies will be used for evaluation of diversity of circulating T cells</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ARS-CoV-2 Antibody Titer</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Antibody titers to SARS-CoV-2 evaluation will be performed in vivo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SARS-CoV-2 Neutralizing Titer</measure>
    <time_frame>up to 28 days</time_frame>
    <description>Neutralizing antibodies are a type of virus specific antibody that not only bind virus but bind in a manner that prevents viral infection. Test will be will be performed in vivo.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Convalescent Plasma (CP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once the patient meets criteria for CP infusion (severity of disease and risk factor determination and absence of exclusion criteria) convalescent plasma will be administered</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Convalescent Plasma (CP)</intervention_name>
    <description>Once the patient meets criteria for CP infusion (severity of disease and risk factor determination and absence of exclusion criteria), an ABO compatible product will be identified. The CP dose administered will be 10mL/kg/dose (up to 2 units per dose) times two doses per patient for a total dose of 20 mL/kg. Patients will be followed for adverse events and clinical response. Research blood testing will be obtained prior to infusion (baseline) and serially weekly afterwards until clinical resolution. Patients will receive 2 doses equaling 20 mL/kg (if available) of ABO compatible CP over 24-48 hours if they do not experience grade 3-5 adverse events that are possible, probably, or definitely attributed to CP after the first dose. Patients will be followed for adverse events for a minimum of 28 days after the last infusion of CP.</description>
    <arm_group_label>Convalescent Plasma (CP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard COVID-19 therapies</intervention_name>
    <description>If clinical status permits, administration of additional COVID-19 therapies should be delayed 48 hours or more from CP infusion completion. Supportive care will be administered by best clinical practice.</description>
    <arm_group_label>Convalescent Plasma (CP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 0 to 22 years of age&#xD;
&#xD;
          -  SARS-CoV-2 infection documented by RNA RT-PCR detection&#xD;
&#xD;
          -  Admitted to an acute care facility&#xD;
&#xD;
          -  Ability of patient or guardian to provide consent and assent (if applicable); if&#xD;
             patient is intubated assent may be waived&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy/ breast feeding&#xD;
&#xD;
          -  Medical condition that increases the risk of plasma infusion&#xD;
&#xD;
          -  Contraindication to transfusion (severe volume overload, history of anaphylaxis to&#xD;
             blood products).&#xD;
&#xD;
        Inclusion criteria for infusion:&#xD;
&#xD;
          -  Severe COVID-19 disease, OR&#xD;
&#xD;
          -  Moderate disease with a risk of progression to severe or life threatening disease, OR&#xD;
&#xD;
          -  Severely immunocompromised patient with any illness attributed to COVID-19 disease&#xD;
             requiring inpatient care.&#xD;
&#xD;
        Exclusion to infusion:&#xD;
&#xD;
          -  Pregnancy/ breast feeding&#xD;
&#xD;
          -  Medical condition that increases the risk of plasma infusion&#xD;
&#xD;
          -  Contraindication to transfusion (severe volume overload, history of anaphylaxis to&#xD;
             blood products).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>22 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Preeti Jaggi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Healthcare of Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>November 13, 2021</last_update_submitted>
  <last_update_submitted_qc>November 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Preeti Jaggi</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Pediatric</keyword>
  <keyword>Convalescent Plasma</keyword>
  <keyword>Safety</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>


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/NCT04458363
org study id: STUDY00000789
nct id: NCT04458363
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
COVID-19 is increasingly affecting children but convalescent plasma (CP) has not been
      adequately studied in children to date. The study will determine safety of convalescent
      plasma for pediatric patients with severe, or at high risk for severe, COVID-19 disease.
COVID19 is an emerging infection with no current approved treatment or prevention. COVID-19
      is increasingly affecting children but convalescent plasma (CP) has not been adequately
      studied in children to date. The study will determine safety of convalescent plasma for
      pediatric patients with severe, or at high risk for severe, COVID-19 disease.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of grade 3-5 adverse events that are possible, probably or definitely related to the convalescent plasma (CP) infusion
time frame: 28 days
description: Safety of convalescent plasma for pediatric patients will be determined by capturing the grade 3-5 adverse events that are possible, probably or definitely related to the CP infusion, defined using the NCI Common Terminology Criteria for Adverse Events (CTCAE)
measure: Change in percent of supplemental oxygen
time frame: Baseline, 72 hours after infusion
description: Change in percent of supplemental oxygen within 72 hours after infusion
measure: Number of patients that required change in level of respiratory support
time frame: Baseline, 72 hours after infusion
description: Number of patients that required change in level of respiratory support such as nasal canula, non-invasive ventilation, mechanical ventilation, high frequency oscillator ventilation, and extracorporeal membrane oxygenation (ECMO)
measure: Mortality
time frame: up to 1 year
description: Number of deaths
measure: Mean length of ICU stay (days)
time frame: Up to 28 days
description: Length of ICU stay (days) will be recorded
measure: Mean length of hospital stay (days)
time frame: Up to 28 days
description: Length of hospital stay (days) will be recorded
measure: Mean length of ventilation (days)
time frame: Up to 28 days
description: Length of ventilation (days) will be recorded
measure: Number of patients with progression to renal dysfunction and/or multisystem organ failure
time frame: up to 1 year
description: Number of patients with progression to renal dysfunction and/or multisystem organ failure will be recorded
measure: IL-6 level
time frame: up to 28 days
description: Cytokine milieu will be assayed by Luminex
measure: Number of anti-SARS CoV 2 specific T cells
time frame: up to 28 days
description: Cellular studies will be used for evaluation of anti-SARS CoV 2 specific T cells
measure: Diversity of circulating T cells
time frame: up to 28 days
description: Cellular studies will be used for evaluation of diversity of circulating T cells
measure: ARS-CoV-2 Antibody Titer
time frame: up to 28 days
description: Antibody titers to SARS-CoV-2 evaluation will be performed in vivo
measure: SARS-CoV-2 Neutralizing Titer
time frame: up to 28 days
description: Neutralizing antibodies are a type of virus specific antibody that not only bind virus but bind in a manner that prevents viral infection. Test will be will be performed in vivo.
arm group label: Convalescent Plasma (CP)
arm group type: Experimental
description: Once the patient meets criteria for CP infusion (severity of disease and risk factor determination and absence of exclusion criteria) convalescent plasma will be administered
intervention type: Biological
intervention name: Convalescent Plasma (CP)
description: Once the patient meets criteria for CP infusion (severity of disease and risk factor determination and absence of exclusion criteria), an ABO compatible product will be identified. The CP dose administered will be 10mL/kg/dose (up to 2 units per dose) times two doses per patient for a total dose of 20 mL/kg. Patients will be followed for adverse events and clinical response. Research blood testing will be obtained prior to infusion (baseline) and serially weekly afterwards until clinical resolution. Patients will receive 2 doses equaling 20 mL/kg (if available) of ABO compatible CP over 24-48 hours if they do not experience grade 3-5 adverse events that are possible, probably, or definitely attributed to CP after the first dose. Patients will be followed for adverse events for a minimum of 28 days after the last infusion of CP.
arm group label: Convalescent Plasma (CP)
intervention type: Drug
intervention name: Standard COVID-19 therapies
description: If clinical status permits, administration of additional COVID-19 therapies should be delayed 48 hours or more from CP infusion completion. Supportive care will be administered by best clinical practice.
arm group label: Convalescent Plasma (CP)
criteria: 
gender: All
minimum age: 0 Years
maximum age: 22 Years
healthy volunteers: No
last name: Preeti Jaggi, MD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Preeti Jaggi
investigator title: Principal Investigator
mesh term: COVID-19
sharing ipd: No