<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/NCT04438694</url>
  </required_header>
  <id_info>
    <org_study_id>N39-2020</org_study_id>
    <nct_id>NCT04438694</nct_id>
  </id_info>
  <brief_title>Assessment of the Effect of Convalescent Plasma Therapy in Patients With Life-threatening COVID19 Infection</brief_title>
  <acronym>CP IN COVID19</acronym>
  <official_title>Assessment of the Effect of Convalescent Plasma Therapy in Patients With Life-threatening COVID19 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  This clinical trial proposal is based on the FDA protocol for emergency use of&#xD;
           convalescent plasma for treatment of COVID-19 cases, and on the WHO guidelines for use&#xD;
           of convalescent plasma in other infectious diseases.&#xD;
&#xD;
        -  This Clinical trial is to be applied in Cairo University quarantine hospital. The&#xD;
           collection, testing and storage of convalescent plasma will be done inside CUH main&#xD;
           blood bank.&#xD;
&#xD;
      The concept of this clinical trial is built on the collection of convalescent plasma from&#xD;
      individuals who had recovered from documented infection with SARS-CoV-2, to be used for&#xD;
      patients with- or at high risk of progression to- severe/life-threatening clinical conditions&#xD;
      due to SARS-CoV-2 infection.&#xD;
&#xD;
      An informed consent is required to join this clinical trial; patients will be transfused with&#xD;
      one or two units of ABO compatible convalescent plasma. Those patients will be followed up&#xD;
      and the clinical and laboratory data will be compiled, including adverse events related to&#xD;
      the administration of convalescent plasma (CP).&#xD;
&#xD;
      Other data to be collected retrospectively will include patient demographics, acute care&#xD;
      facility resource utilization (total length of stay, days in ICU, days intubated, and&#xD;
      survival till discharge from an acute care facility).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be done inside Cairo university hospitals, it will involve a number of CP&#xD;
      donors who were recovered from COVID-19 infection and were treated at Cairo University&#xD;
      isolation hospital. The CP donation process will take place at CUH blood bank ,the number of&#xD;
      the donors will be determined at the end of the study as it will vary according to the&#xD;
      donation process .&#xD;
&#xD;
      The study will also include sixty seven /life threatening COVID-19 patients admitted to Cairo&#xD;
      University isolation hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This study is a prospective, single-institution, single-arm, study using a historical control group for comparison. Open label, 2 arms: SOC and SOC+CP</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of hospitalization/Recovery status</measure>
    <time_frame>2-3 weeks</time_frame>
    <description>Decrease of hospital days of safety until discharge</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">67</enrollment>
  <condition>COVID19</condition>
  <arm_group>
    <arm_group_label>STANDARD OF COARE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receiving SOC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>STANDARD CP DOSE Adm (Two infusions)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two infusions 48 hours apart</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Convalescent Plasma</intervention_name>
    <description>Convalescent Plasma</description>
    <arm_group_label>STANDARD CP DOSE Adm (Two infusions)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Standard of Care drugs administered as per Cairo University ICU protocol</description>
    <arm_group_label>STANDARD CP DOSE Adm (Two infusions)</arm_group_label>
    <arm_group_label>STANDARD OF COARE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have laboratory confirmed COVID-19 and admitted to Cairo University isolation&#xD;
             hospital.&#xD;
&#xD;
          -  Admitted to acute care facility.&#xD;
&#xD;
          -  Must have severe or immediately life-threatening COVID-19:&#xD;
&#xD;
        Severe disease is defined as:&#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, and/or&#xD;
&#xD;
          -  lung infiltrates &gt; 50% within 24 to 48 hours (CT finding)&#xD;
&#xD;
        Life-threatening disease is defined as:&#xD;
&#xD;
          -  respiratory failure,&#xD;
&#xD;
          -  septic shock, and/or&#xD;
&#xD;
          -  multiple organ dysfunction or failure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Autoimmune disorder&#xD;
&#xD;
          -  Participated in a CP trial in the past 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nermeen ElDesouky, MD PhD</last_name>
    <phone>01006029006</phone>
    <email>nermeen.eldesoukey@kasralainy.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cairo University Hospital</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mostafa ElShazly, MD PhD</last_name>
    </contact>
    <investigator>
      <last_name>Omar Fahmy, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Akram AbdelBarry, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yasser Nassar, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Heba Sharaf, Md PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Azza AboulEnin, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ashraf ElFiky, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ahmed Mokhtar, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Taghreed Gaafar, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nevine S El Shakhs, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>September 25, 2020</last_update_submitted>
  <last_update_submitted_qc>September 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Nermeen El Desouky</investigator_full_name>
    <investigator_title>PROFESSOR OF CLINICAL PATHOLOGY</investigator_title>
  </responsible_party>
  <keyword>DONOR</keyword>
  <keyword>RECIPIENT</keyword>
  <keyword>CONVALESCENT PLASMA</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/NCT04438694
org study id: N39-2020
nct id: NCT04438694
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
-  This clinical trial proposal is based on the FDA protocol for emergency use of
           convalescent plasma for treatment of COVID-19 cases, and on the WHO guidelines for use
           of convalescent plasma in other infectious diseases.

        -  This Clinical trial is to be applied in Cairo University quarantine hospital. The
           collection, testing and storage of convalescent plasma will be done inside CUH main
           blood bank.

      The concept of this clinical trial is built on the collection of convalescent plasma from
      individuals who had recovered from documented infection with SARS-CoV-2, to be used for
      patients with- or at high risk of progression to- severe/life-threatening clinical conditions
      due to SARS-CoV-2 infection.

      An informed consent is required to join this clinical trial; patients will be transfused with
      one or two units of ABO compatible convalescent plasma. Those patients will be followed up
      and the clinical and laboratory data will be compiled, including adverse events related to
      the administration of convalescent plasma (CP).

      Other data to be collected retrospectively will include patient demographics, acute care
      facility resource utilization (total length of stay, days in ICU, days intubated, and
      survival till discharge from an acute care facility).
This study will be done inside Cairo university hospitals, it will involve a number of CP
      donors who were recovered from COVID-19 infection and were treated at Cairo University
      isolation hospital. The CP donation process will take place at CUH blood bank ,the number of
      the donors will be determined at the end of the study as it will vary according to the
      donation process .

      The study will also include sixty seven /life threatening COVID-19 patients admitted to Cairo
      University isolation hospital.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: This study is a prospective, single-institution, single-arm, study using a historical control group for comparison. Open label, 2 arms: SOC and SOC+CP
primary purpose: Treatment
masking: None (Open Label)
measure: Duration of hospitalization/Recovery status
time frame: 2-3 weeks
description: Decrease of hospital days of safety until discharge
arm group label: STANDARD OF COARE
arm group type: Active Comparator
description: Receiving SOC
arm group label: STANDARD CP DOSE Adm (Two infusions)
arm group type: Experimental
description: Two infusions 48 hours apart
intervention type: Biological
intervention name: Convalescent Plasma
description: Convalescent Plasma
arm group label: STANDARD CP DOSE Adm (Two infusions)
intervention type: Drug
intervention name: Standard of Care
description: Standard of Care drugs administered as per Cairo University ICU protocol
arm group label: STANDARD CP DOSE Adm (Two infusions)
arm group label: STANDARD OF COARE
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nermeen ElDesouky, MD PhD
phone: 01006029006
email: nermeen.eldesoukey@kasralainy.edu.eg
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Nermeen El Desouky
investigator title: PROFESSOR OF CLINICAL PATHOLOGY
mesh term: COVID-19
sharing ipd: No