<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/NCT04497324</url>
  </required_header>
  <id_info>
    <org_study_id>PER-016-20</org_study_id>
    <secondary_id>20997</secondary_id>
    <nct_id>NCT04497324</nct_id>
  </id_info>
  <brief_title>PERUCONPLASMA: Evaluating the Use of Convalescent Plasma as Management of COVID-19</brief_title>
  <official_title>PERUCONPLASMA: Randomized Clinical Trial to Evaluate Safety and Efficacy of the Use of Convalescent Plasma in Hospitalized Patients With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Peruana Cayetano Heredia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Peruana Cayetano Heredia</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>
      Open label controlled clinical trial to evaluate the safety and efficacy of the use of&#xD;
      convalescent plasma in hospitalized patients with COVID-19 infection. This study will have&#xD;
      two arms, one arm will receive convalescent plasma plus standard of care, and the other arm&#xD;
      will receive standard of care only. Adults older than 18 years old, hospitalized with&#xD;
      diagnosis of COVID-19 confirmed by a laboratory test (molecular or serology), with severe or&#xD;
      life-threatening disease, will be included to the study after obtaining inform consent by the&#xD;
      patient of a direct family member. Participants will be then randomized 1:1 to the&#xD;
      experimental and the control groups.&#xD;
&#xD;
      Participants at the experimental group will receive 1 to 2 units of ABO compatible COVID-19&#xD;
      convalescent plasma (200 ml to 250 ml each) within 48 hours, in addition to the standard of&#xD;
      care. Participants at the control group will receive standard of care. Safety of convalescent&#xD;
      plasma administration will be evaluated, as well as other indicators of clinical efficacy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study protocol can be found in:&#xD;
&#xD;
      https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05189-6&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2020</start_date>
  <completion_date type="Actual">April 17, 2021</completion_date>
  <primary_completion_date type="Actual">April 17, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Transfusion-related Serious Adverse Events</measure>
    <time_frame>14 days after randomization</time_frame>
    <description>Incidence of transfusion-related Serious Adverse Events, according to the Hemovigilance Module Surveillance Protocol v2.5.2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause in-hospital mortality</measure>
    <time_frame>30 days after randomization</time_frame>
    <description>Death during hospitalization within the first 30 days after enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>30 days after randomization or until hospital discharge, whatever comes first</time_frame>
    <description>Number of days from date of enrollment to date of discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ICU stay</measure>
    <time_frame>30 days after randomization or until hospital discharge, whatever comes first</time_frame>
    <description>Number of days from date of admission to the ICU to date of discharge from ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need of invasive mechanical ventilation</measure>
    <time_frame>30 days after randomization or until hospital discharge, whatever comes first</time_frame>
    <description>Requirement of invasive mechanical ventilation (Yes/No). Evaluated only for those participants that were on non-invasive ventilatory support at time of randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>30 days after randomization or until hospital discharge, whatever comes first</time_frame>
    <description>Number of days from date of intubation to date of successful extubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Improvement at 14 days</measure>
    <time_frame>At 3, 14 and 30 days after randomization</time_frame>
    <description>Improvement of 2 or more points in the WHO progression scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Convalescent plasma</intervention_name>
    <description>Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized 18 years old or older patient with COVID-19 disease, confirmed by a&#xD;
             molecular test or a serologic test, along with a typical COVID-19 clinical&#xD;
             presentation.&#xD;
&#xD;
          -  Severe or critical disease caused by COVID-19 Severe disease is defined as 2 or more&#xD;
             of the following criteria:&#xD;
&#xD;
               -  Respiratory frequency &gt;22&#xD;
&#xD;
               -  O2 saturation ≤93%&#xD;
&#xD;
               -  PaO2 50mmHg&#xD;
&#xD;
               -  PaO2/FiO2 &lt;300&#xD;
&#xD;
          -  Or critical disease with one or more of the following criteria:&#xD;
&#xD;
               -  Respiratory insufficiency with requirement of mechanical ventilation within the&#xD;
                  last 72hours&#xD;
&#xD;
               -  Shock&#xD;
&#xD;
          -  Inform consent signed by patient or direct family member.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication for transfusion (history of TRALI or TACO, history of anaphylaxis to&#xD;
             blood components&#xD;
&#xD;
          -  Multiorgan failure, defined by a SOFA score of &gt;5&#xD;
&#xD;
          -  hemodynamically unstable, with mean arterial pressure &lt;60 mmHg, refractory to&#xD;
             vasopressors use&#xD;
&#xD;
          -  Uncontrolled concomitant infection&#xD;
&#xD;
          -  Disseminated intravascular coagulation&#xD;
&#xD;
          -  Myocardial infarction&#xD;
&#xD;
          -  Acute coronary disease&#xD;
&#xD;
          -  Patient on dialysis&#xD;
&#xD;
          -  Intracranial bleeding active within the last 7 days&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fiorella Krapp Lopez, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Peruana Cayetano Heredia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Patricia Garcia Funegra, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Peruana Cayetano Heredia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Cayetano Heredia</name>
      <address>
        <city>Lima</city>
        <zip>15102</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nacional Hipolito Unanue</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Peru</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>October 20, 2021</last_update_submitted>
  <last_update_submitted_qc>October 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</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/NCT04497324
org study id: PER-016-20
secondary id: 20997
nct id: NCT04497324
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Open label controlled clinical trial to evaluate the safety and efficacy of the use of
      convalescent plasma in hospitalized patients with COVID-19 infection. This study will have
      two arms, one arm will receive convalescent plasma plus standard of care, and the other arm
      will receive standard of care only. Adults older than 18 years old, hospitalized with
      diagnosis of COVID-19 confirmed by a laboratory test (molecular or serology), with severe or
      life-threatening disease, will be included to the study after obtaining inform consent by the
      patient of a direct family member. Participants will be then randomized 1:1 to the
      experimental and the control groups.

      Participants at the experimental group will receive 1 to 2 units of ABO compatible COVID-19
      convalescent plasma (200 ml to 250 ml each) within 48 hours, in addition to the standard of
      care. Participants at the control group will receive standard of care. Safety of convalescent
      plasma administration will be evaluated, as well as other indicators of clinical efficacy.
The study protocol can be found in:

      https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05189-6
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Transfusion-related Serious Adverse Events
time frame: 14 days after randomization
description: Incidence of transfusion-related Serious Adverse Events, according to the Hemovigilance Module Surveillance Protocol v2.5.2
measure: All-cause in-hospital mortality
time frame: 30 days after randomization
description: Death during hospitalization within the first 30 days after enrollment
measure: Length of hospital stay
time frame: 30 days after randomization or until hospital discharge, whatever comes first
description: Number of days from date of enrollment to date of discharge
measure: Length of ICU stay
time frame: 30 days after randomization or until hospital discharge, whatever comes first
description: Number of days from date of admission to the ICU to date of discharge from ICU
measure: Need of invasive mechanical ventilation
time frame: 30 days after randomization or until hospital discharge, whatever comes first
description: Requirement of invasive mechanical ventilation (Yes/No). Evaluated only for those participants that were on non-invasive ventilatory support at time of randomization
measure: Duration of mechanical ventilation
time frame: 30 days after randomization or until hospital discharge, whatever comes first
description: Number of days from date of intubation to date of successful extubation
measure: Clinical Improvement at 14 days
time frame: At 3, 14 and 30 days after randomization
description: Improvement of 2 or more points in the WHO progression scale
arm group label: Experimental group
arm group type: Experimental
description: Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care.
arm group label: Control group
arm group type: No Intervention
description: Standard of care
intervention type: Biological
intervention name: Convalescent plasma
description: Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care.
arm group label: Experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fiorella Krapp Lopez, MD, MSc
role: Principal Investigator
affiliation: Universidad Peruana Cayetano Heredia
last name: Patricia Garcia Funegra, MD, MSc
role: Principal Investigator
affiliation: Universidad Peruana Cayetano Heredia
facility: 
facility: 
country: Peru
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No