<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/NCT04472572</url>
  </required_header>
  <id_info>
    <org_study_id>Pro2020-0663</org_study_id>
    <nct_id>NCT04472572</nct_id>
  </id_info>
  <brief_title>Expanded Access to Convalescent Plasma for Treatment of COVID-19</brief_title>
  <official_title>Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hackensack Meridian Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hackensack Meridian Health</source>
  <brief_summary>
    <textblock>
      This expanded access program will provide access to investigational convalescent plasma for&#xD;
      patients at Hackensack University Medical Center infected with SARS-CoV-2 who have severe or&#xD;
      life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of&#xD;
      progression to severe or life-threatening disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This expanded access program will provide access to investigational convalescent plasma for&#xD;
      patients at Hackensack University Medical Center infected with SARS-CoV-2 who have severe or&#xD;
      life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of&#xD;
      progression to severe or life-threatening disease. Following enrollment on the protocol and&#xD;
      provision of informed consent, patients will be transfused with approximately 200-500 mL of&#xD;
      ABO compatible convalescent plasma obtained from individuals who have recovered from&#xD;
      documented infection with SARS-CoV-2 and who have been found to have high anti-SARS-CoV2&#xD;
      titers. Safety information collected will include serious adverse events judged to be related&#xD;
      to the administration of convalescent plasma. Other information to be collected&#xD;
      retrospectively will include patient demographics, resource utilization (total length of&#xD;
      stay, days in ICU, days intubated, and survival to discharge from the facility.&#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-19</condition>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Convalescent Plasma</intervention_name>
    <description>Fresh or frozen plasma will be infused one time to patients with COVID-19 infection</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age at least 18 years&#xD;
&#xD;
          2. Laboratory confirmed diagnosis of infection with SARS-CoV-2&#xD;
&#xD;
          3. Admitted to the hospital for the treatment of COVID-19 complications&#xD;
&#xD;
          4. Severe or life threatening COVID-19, or judged by the treating provider to be at high&#xD;
             risk of progression to severe or life-threatening disease&#xD;
&#xD;
          5. Informed consent provided by the patient or healthcare proxy&#xD;
&#xD;
          6. Severe COVID-19 is defined by one or more of the following:&#xD;
&#xD;
               -  dyspnea&#xD;
&#xD;
               -  respiratory frequency ≥ 30/min&#xD;
&#xD;
               -  blood oxygen saturation ≤ 93%&#xD;
&#xD;
               -  partial pressure of arterial oxygen to fraction of inspired oxygen ratio &lt; 300&#xD;
&#xD;
               -  lung infiltrates &gt; 50% within 24 to 48 hours&#xD;
&#xD;
        Life-threatening COVID-19 is defined as one or more of the following:&#xD;
&#xD;
          -  respiratory failure/mechanical ventilation&#xD;
&#xD;
          -  septic shock&#xD;
&#xD;
          -  multiple organ dysfunction or failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Michele Donato</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hackensack Meridian Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Roback JD, Guarner J. Convalescent Plasma to Treat COVID-19: Possibilities and Challenges. JAMA. 2020 Apr 28;323(16):1561-1562. doi: 10.1001/jama.2020.4940. No abstract available.</citation>
    <PMID>32219429</PMID>
  </reference>
  <reference>
    <citation>Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.</citation>
    <PMID>32219428</PMID>
  </reference>
  <reference>
    <citation>Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16.</citation>
    <PMID>25030060</PMID>
  </reference>
  <reference>
    <citation>Ko JH, Seok H, Cho SY, Ha YE, Baek JY, Kim SH, Kim YJ, Park JK, Chung CR, Kang ES, Cho D, Muller MA, Drosten C, Kang CI, Chung DR, Song JH, Peck KR. Challenges of convalescent plasma infusion therapy in Middle East respiratory coronavirus infection: a single centre experience. Antivir Ther. 2018;23(7):617-622. doi: 10.3851/IMP3243. Epub 2018 Jun 20.</citation>
    <PMID>29923831</PMID>
  </reference>
  <reference>
    <citation>https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds</citation>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>October 7, 2022</last_update_submitted>
  <last_update_submitted_qc>October 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronavirus</keyword>
  <keyword>Covid19</keyword>
  <keyword>SARS-CoV-2</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/NCT04472572
org study id: Pro2020-0663
nct id: NCT04472572
lead sponsor: 
This expanded access program will provide access to investigational convalescent plasma for
      patients at Hackensack University Medical Center infected with SARS-CoV-2 who have severe or
      life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of
      progression to severe or life-threatening disease.
This expanded access program will provide access to investigational convalescent plasma for
      patients at Hackensack University Medical Center infected with SARS-CoV-2 who have severe or
      life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of
      progression to severe or life-threatening disease. Following enrollment on the protocol and
      provision of informed consent, patients will be transfused with approximately 200-500 mL of
      ABO compatible convalescent plasma obtained from individuals who have recovered from
      documented infection with SARS-CoV-2 and who have been found to have high anti-SARS-CoV2
      titers. Safety information collected will include serious adverse events judged to be related
      to the administration of convalescent plasma. Other information to be collected
      retrospectively will include patient demographics, resource utilization (total length of
      stay, days in ICU, days intubated, and survival to discharge from the facility.
expanded access type treatment: Yes
intervention type: Biological
intervention name: Convalescent Plasma
description: Fresh or frozen plasma will be infused one time to patients with COVID-19 infection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Michele Donato
role: Principal Investigator
affiliation: Hackensack Meridian Health
facility: 
country: United States
citation: Roback JD, Guarner J. Convalescent Plasma to Treat COVID-19: Possibilities and Challenges. JAMA. 2020 Apr 28;323(16):1561-1562. doi: 10.1001/jama.2020.4940. No abstract available.
PMID: 32219429
citation: Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.
PMID: 32219428
citation: Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16.
PMID: 25030060
citation: Ko JH, Seok H, Cho SY, Ha YE, Baek JY, Kim SH, Kim YJ, Park JK, Chung CR, Kang ES, Cho D, Muller MA, Drosten C, Kang CI, Chung DR, Song JH, Peck KR. Challenges of convalescent plasma infusion therapy in Middle East respiratory coronavirus infection: a single centre experience. Antivir Ther. 2018;23(7):617-622. doi: 10.3851/IMP3243. Epub 2018 Jun 20.
PMID: 29923831
citation: https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds
responsible party type: Sponsor
mesh term: COVID-19