<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/NCT04445207</url>
  </required_header>
  <id_info>
    <org_study_id>H000020420</org_study_id>
    <nct_id>NCT04445207</nct_id>
  </id_info>
  <brief_title>Experimental Expanded Access Treatment With Convalescent Plasma for the Treatment of Patients With COVID-19</brief_title>
  <official_title>Experimental Expanded Access Treatment With Convalescent Plasma for the Treatment of Patients With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jonathan Gerber</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Massachusetts, Worcester</source>
  <brief_summary>
    <textblock>
      The purpose of this program is to see if giving convalescent plasma to individuals who test&#xD;
      positive for COVID-19 may reduce their symptoms and help minimize complications from the&#xD;
      illness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As individuals are exposed to pathogens, the body's immune system works to create antibodies&#xD;
      toward those pathogens. These antibodies can be found in the plasma portion of the blood.&#xD;
      This plasma is referred to as &quot;Convalescent plasma&quot; and contains these infection fighting&#xD;
      antibodies. Through a blood donation, this convalescent plasma is collected from a recovered&#xD;
      person and transfused to a sick patient who is still fighting the same virus. This protocol&#xD;
      will make convalescent COVID-19 plasma available to individuals who meet the eligibility&#xD;
      criteria described.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>No longer available</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <expanded_access_info>
    <expanded_access_type_treatment>Yes</expanded_access_type_treatment>
  </expanded_access_info>
  <condition>COVID</condition>
  <condition>Sars-CoV2</condition>
  <condition>Corona Virus Infection</condition>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Convalescent Plasma</intervention_name>
    <description>One to two 200 mL units of Convalescent plasma per infusion, up to 6 total units within a 3-week period.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 12 years of age&#xD;
&#xD;
          -  Covid-19 Convalescent Plasma (CCP) treatment is in line with the patient's current&#xD;
             goals of care (i.e. recipient cannot be DNI status)&#xD;
&#xD;
          -  Laboratory confirmed diagnosis of infection with SARS-CoV-2 that is severe or life&#xD;
             threatening OR the individual is judged by the treating provider to be at a high risk&#xD;
             of progression to severe or life-threatening disease.&#xD;
&#xD;
          -  Severe COVID-19 is defined by one or more of the following:&#xD;
&#xD;
               1. Dyspnea&#xD;
&#xD;
               2. Respiratory frequency ≥ 30/min&#xD;
&#xD;
               3. Blood oxygen saturation ≤ 93%&#xD;
&#xD;
               4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio &lt; 300&#xD;
&#xD;
               5. Lung infiltrates &gt; 50% within 24-48 hours&#xD;
&#xD;
          -  Life-threatening COVID-19 is defined as one or more of the following:&#xD;
&#xD;
               1. Respiratory failure&#xD;
&#xD;
               2. Septic shock&#xD;
&#xD;
               3. Multiple organ dysfunction or failure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of prior life-threatening reactions to transfusion of blood products&#xD;
&#xD;
          -  Not receiving other therapies that would preclude plasma transfusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Jonathan Gerber, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMASS MEDICAL SCHOOL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UMass Medical School</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>May 23, 2023</last_update_submitted>
  <last_update_submitted_qc>May 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Massachusetts, Worcester</investigator_affiliation>
    <investigator_full_name>Jonathan Gerber</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Coronavirus</keyword>
  <keyword>Sars-CoV2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</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/NCT04445207
org study id: H000020420
nct id: NCT04445207
lead sponsor: 
The purpose of this program is to see if giving convalescent plasma to individuals who test
      positive for COVID-19 may reduce their symptoms and help minimize complications from the
      illness.
As individuals are exposed to pathogens, the body's immune system works to create antibodies
      toward those pathogens. These antibodies can be found in the plasma portion of the blood.
      This plasma is referred to as "Convalescent plasma" and contains these infection fighting
      antibodies. Through a blood donation, this convalescent plasma is collected from a recovered
      person and transfused to a sick patient who is still fighting the same virus. This protocol
      will make convalescent COVID-19 plasma available to individuals who meet the eligibility
      criteria described.
expanded access type treatment: Yes
intervention type: Biological
intervention name: Convalescent Plasma
description: One to two 200 mL units of Convalescent plasma per infusion, up to 6 total units within a 3-week period.
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
last name: Jonathan Gerber, MD
role: Principal Investigator
affiliation: UMASS MEDICAL SCHOOL
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Massachusetts, Worcester
investigator full name: Jonathan Gerber
investigator title: Associate Professor
mesh term: COVID-19
mesh term: Coronavirus Infections