<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/NCT04425837</url>
  </required_header>
  <id_info>
    <org_study_id>PLASMA COVID-19</org_study_id>
    <nct_id>NCT04425837</nct_id>
  </id_info>
  <brief_title>Effectiveness and Safety of Convalescent Plasma in Patients With High-risk COVID-19</brief_title>
  <official_title>Effectiveness and Safety of Convalescent Plasma in Patients With High-risk COVID-19: A Randomized, Controlled Study CRI-CP (Coronavirus Investigation - Convalescent Plasma)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación Santa Fe de Bogota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación Santa Fe de Bogota</source>
  <oversight_info>
    <has_dmc>No</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>
      The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected the global&#xD;
      population with significant morbidity and mortality. One of the main concerns is the&#xD;
      management of the patients since there is no specific treatment for this condition.&#xD;
      Therefore, in SARS-CoV-2 patients the compassionate use of off-label therapies has been&#xD;
      initiated; such as the use of plasma from convalescent patients. This treatment has been used&#xD;
      in other pandemics like SARS-CoV-1, H5N1, H1N1, Ebola, among others. This study is a phase&#xD;
      II/III randomized clinical trial to assess the effectiveness and safety of convalescent&#xD;
      plasma administration in patients with high-risk SARS-CoV-2.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase II/III randomized clinical trial to assess the effectiveness and safety of&#xD;
      anti-SARS-CoV-2 convalescent plasma in i) hospitalized adult patients with high-risk of&#xD;
      progression SARS-CoV-2 infection and ii) patients in Intensive Care Unit (ICU).&#xD;
&#xD;
      Compatible ABO plasma from convalescent patients will be administered at a dose of 400 ml&#xD;
      divided into two doses intravenously. Outcomes will be measured as follows:&#xD;
&#xD;
      * Group of patients with critical illness:&#xD;
&#xD;
      Primary outcomes (Effectiveness and safety):&#xD;
&#xD;
        -  Mortality&#xD;
&#xD;
        -  Safety: Presence of adverse events&#xD;
&#xD;
      Secondary outcomes:&#xD;
&#xD;
        -  Intensive care unit length of stay&#xD;
&#xD;
        -  Evolution of clinical and paraclinical aspects.&#xD;
&#xD;
             -  Group of patients at high risk of progression:&#xD;
&#xD;
      Primary outcomes (Effectiveness and safety):&#xD;
&#xD;
        -  Mortality&#xD;
&#xD;
        -  Safety: Presence of adverse events&#xD;
&#xD;
        -  Admission to ICU in 30 days&#xD;
&#xD;
        -  Mechanical ventilation requirement&#xD;
&#xD;
      Secondary outcomes:&#xD;
&#xD;
        -  Hospital/Intensive care unit length of stay&#xD;
&#xD;
        -  Evolution of clinical and paraclinical aspects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">February 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>Up to 30 days after the study enrollment</time_frame>
    <description>Death of the patient (yes/no)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Up to 30 days after the study enrollment</time_frame>
    <description>Presence of any of the following adverse events (yes/no):&#xD;
Nonhemolytic febrile reactions&#xD;
Allergic reactions&#xD;
Acute hemolytic reactions&#xD;
Non-immune hemolysis&#xD;
Acute transfusion-related lung damage&#xD;
Transfusion-related circulatory overload&#xD;
Metabolic reactions&#xD;
Hypotensive reactions&#xD;
Delayed hemolytic reactions&#xD;
Post transfusion purple&#xD;
Graft versus host disease&#xD;
Bacterial contamination of blood components&#xD;
Viral infections&#xD;
Other infections (syphilis, prions, malaria, Chagas, yellow fever, dengue)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ICU admission</measure>
    <time_frame>Up to 30 days after the study enrollment</time_frame>
    <description>Admitted to intensive care units (ICUs) (yes/no)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mechanical ventilation</measure>
    <time_frame>Up to 30 days after the study enrollment</time_frame>
    <description>Mechanical ventilation requirement (yes/no)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU length</measure>
    <time_frame>Up to 30 days after the study enrollment</time_frame>
    <description>Intensive care unit length of stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction of D Dimer</measure>
    <time_frame>Assessment at day 30 after study enrollment</time_frame>
    <description>D dimer reduction below 1mcg / ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDH reduction</measure>
    <time_frame>Assessment at day 30 after study enrollment</time_frame>
    <description>Reduction of LDH below 350 IU / L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction of Troponin level</measure>
    <time_frame>Assessment at day 30 after study enrollment</time_frame>
    <description>Reduction of troponin level to than 8 pg / mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in ferritin level</measure>
    <time_frame>Assessment at day 30 after study enrollment</time_frame>
    <description>Decrease in ferritin level below 1025 mcg / L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in procalcitonin level</measure>
    <time_frame>Assessment at day 30 after study enrollment</time_frame>
    <description>Decrease in procalcitonin level below 0.1ng / ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in CRP</measure>
    <time_frame>Assessment at day 30 after study enrollment</time_frame>
    <description>Decrease in CRP level bellow &lt;8 mg / L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increase in lymphocyte count</measure>
    <time_frame>Assessment at day 30 after study enrollment</time_frame>
    <description>Increase in lymphocyte count greater than 0.6 x 10-9 / L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increase in PaO2 / Fio2</measure>
    <time_frame>Assessment at day 30 after study enrollment</time_frame>
    <description>Increase in PaO2 / Fio2 greater than 200</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in Sequential Organ failure assessment (SOFA ) score</measure>
    <time_frame>Assessment at day 30 after study enrollment</time_frame>
    <description>Scale of 24 points, greater number indicates worst outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extracorporeal membrane oxygenation (ECMO)</measure>
    <time_frame>Assessment at day 30 after study enrollment</time_frame>
    <description>Extracorporeal membrane oxygenation requirement (ECMO)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung infiltration</measure>
    <time_frame>Assessment at day 30 after study enrollment</time_frame>
    <description>Decrease in the percentage of lung infiltration</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">236</enrollment>
  <condition>Sars-CoV2</condition>
  <condition>Covid-19</condition>
  <arm_group>
    <arm_group_label>Standard care alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>SARS-CoV-2 convalescent plasma treatment plus standard care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>SARS-CoV-2 convalescent plasma treatment</intervention_name>
    <description>Plasma transfusion of convalescent patients from COVID-19 with negative RT-PCR, and antibody titers of 1:160 or greater at a dose of 400ml distributed in two doses administered on the same day intravenous administration</description>
    <arm_group_label>SARS-CoV-2 convalescent plasma treatment plus standard care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard care</intervention_name>
    <description>Standard care according to guidelines and national regulations</description>
    <arm_group_label>SARS-CoV-2 convalescent plasma treatment plus standard care</arm_group_label>
    <arm_group_label>Standard care alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients&#xD;
&#xD;
          -  Patients diagnosed with COVID-19 infection by RT-PCR technique&#xD;
&#xD;
          -  Patients ≥ 18 years of age&#xD;
&#xD;
          -  Patients in standard care according to the national guide&#xD;
&#xD;
          -  Onset of symptoms ≤ 14 days&#xD;
&#xD;
          -  Signature of informed consent report&#xD;
&#xD;
        Patients at high risk of progression, defined by all of the following:&#xD;
&#xD;
          -  Score greater than 9 on the CALL scale&#xD;
&#xD;
          -  Pao2 / Fio2 ≤ 200 (parameters adjusted to the height of Bogotá, Colombia)&#xD;
&#xD;
          -  X-ray or CT compatible with pneumonia&#xD;
&#xD;
          -  Hospitalized patients&#xD;
&#xD;
        Critically ill patients, defined by any of the following:&#xD;
&#xD;
          -  Mechanical ventilation requeriment&#xD;
&#xD;
          -  Patients in Intensive Care Unit or Intermediate Care Unit&#xD;
&#xD;
          -  Ventilatory failure, septic shock, dysfunction or multi-organ failure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Negative RT-PCR result from secretion 48 hours prior to study recruitment&#xD;
&#xD;
          -  History of allergic reaction to blood or plasma in patients with a known history of&#xD;
             IgA deficiency&#xD;
&#xD;
          -  Patients participating in other clinical trial&#xD;
&#xD;
          -  History of allergy to blood products&#xD;
&#xD;
          -  History of confirmed infection and that required antibiotic or antifungal treatment 30&#xD;
             days prior to recruitment&#xD;
&#xD;
          -  Pregnant women&#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_contact>
    <last_name>Guillermo E Quintero, Hematologist</last_name>
    <phone>5716030303</phone>
    <phone_ext>1221</phone_ext>
    <email>quiquequintero@yahoo.com.mx</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>José A De la Hoz, Epidemiologist</last_name>
    <phone>5716030303</phone>
    <phone_ext>1127</phone_ext>
    <email>jose.delahoz@fsfb.org.co</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fundación Santa Fe de Bogotá</name>
      <address>
        <city>Bogotá</city>
        <state>Cundinamarca</state>
        <zip>110111</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <contact>
      <last_name>José De la Hoz, Epidemiologist</last_name>
      <phone>5716030303</phone>
      <phone_ext>1127</phone_ext>
      <email>jose.delahoz@fsfb.org.co</email>
    </contact>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundación Santa Fe de Bogota</investigator_affiliation>
    <investigator_full_name>Guillermo Enrique Quintero-Vega</investigator_full_name>
    <investigator_title>Hematologist</investigator_title>
  </responsible_party>
  <keyword>COVID-19 serotherapy</keyword>
  <keyword>Mortality</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>
  <!-- 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/NCT04425837
org study id: PLASMA COVID-19
nct id: NCT04425837
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected the global
      population with significant morbidity and mortality. One of the main concerns is the
      management of the patients since there is no specific treatment for this condition.
      Therefore, in SARS-CoV-2 patients the compassionate use of off-label therapies has been
      initiated; such as the use of plasma from convalescent patients. This treatment has been used
      in other pandemics like SARS-CoV-1, H5N1, H1N1, Ebola, among others. This study is a phase
      II/III randomized clinical trial to assess the effectiveness and safety of convalescent
      plasma administration in patients with high-risk SARS-CoV-2.
This is a Phase II/III randomized clinical trial to assess the effectiveness and safety of
      anti-SARS-CoV-2 convalescent plasma in i) hospitalized adult patients with high-risk of
      progression SARS-CoV-2 infection and ii) patients in Intensive Care Unit (ICU).

      Compatible ABO plasma from convalescent patients will be administered at a dose of 400 ml
      divided into two doses intravenously. Outcomes will be measured as follows:

      * Group of patients with critical illness:

      Primary outcomes (Effectiveness and safety):

        -  Mortality

        -  Safety: Presence of adverse events

      Secondary outcomes:

        -  Intensive care unit length of stay

        -  Evolution of clinical and paraclinical aspects.

             -  Group of patients at high risk of progression:

      Primary outcomes (Effectiveness and safety):

        -  Mortality

        -  Safety: Presence of adverse events

        -  Admission to ICU in 30 days

        -  Mechanical ventilation requirement

      Secondary outcomes:

        -  Hospital/Intensive care unit length of stay

        -  Evolution of clinical and paraclinical aspects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Mortality
time frame: Up to 30 days after the study enrollment
description: Death of the patient (yes/no)
measure: Adverse events
time frame: Up to 30 days after the study enrollment
description: Presence of any of the following adverse events (yes/no):
Nonhemolytic febrile reactions
Allergic reactions
Acute hemolytic reactions
Non-immune hemolysis
Acute transfusion-related lung damage
Transfusion-related circulatory overload
Metabolic reactions
Hypotensive reactions
Delayed hemolytic reactions
Post transfusion purple
Graft versus host disease
Bacterial contamination of blood components
Viral infections
Other infections (syphilis, prions, malaria, Chagas, yellow fever, dengue)
measure: ICU admission
time frame: Up to 30 days after the study enrollment
description: Admitted to intensive care units (ICUs) (yes/no)
measure: Mechanical ventilation
time frame: Up to 30 days after the study enrollment
description: Mechanical ventilation requirement (yes/no)
measure: ICU length
time frame: Up to 30 days after the study enrollment
description: Intensive care unit length of stay
measure: Reduction of D Dimer
time frame: Assessment at day 30 after study enrollment
description: D dimer reduction below 1mcg / ml
measure: LDH reduction
time frame: Assessment at day 30 after study enrollment
description: Reduction of LDH below 350 IU / L
measure: Reduction of Troponin level
time frame: Assessment at day 30 after study enrollment
description: Reduction of troponin level to than 8 pg / mL
measure: Decrease in ferritin level
time frame: Assessment at day 30 after study enrollment
description: Decrease in ferritin level below 1025 mcg / L
measure: Decrease in procalcitonin level
time frame: Assessment at day 30 after study enrollment
description: Decrease in procalcitonin level below 0.1ng / ml
measure: Decrease in CRP
time frame: Assessment at day 30 after study enrollment
description: Decrease in CRP level bellow <8 mg / L
measure: Increase in lymphocyte count
time frame: Assessment at day 30 after study enrollment
description: Increase in lymphocyte count greater than 0.6 x 10-9 / L
measure: Increase in PaO2 / Fio2
time frame: Assessment at day 30 after study enrollment
description: Increase in PaO2 / Fio2 greater than 200
measure: Decrease in Sequential Organ failure assessment (SOFA ) score
time frame: Assessment at day 30 after study enrollment
description: Scale of 24 points, greater number indicates worst outcome
measure: Extracorporeal membrane oxygenation (ECMO)
time frame: Assessment at day 30 after study enrollment
description: Extracorporeal membrane oxygenation requirement (ECMO)
measure: Lung infiltration
time frame: Assessment at day 30 after study enrollment
description: Decrease in the percentage of lung infiltration
arm group label: Standard care alone
arm group type: Active Comparator
arm group label: SARS-CoV-2 convalescent plasma treatment plus standard care
arm group type: Experimental
intervention type: Biological
intervention name: SARS-CoV-2 convalescent plasma treatment
description: Plasma transfusion of convalescent patients from COVID-19 with negative RT-PCR, and antibody titers of 1:160 or greater at a dose of 400ml distributed in two doses administered on the same day intravenous administration
arm group label: SARS-CoV-2 convalescent plasma treatment plus standard care
intervention type: Other
intervention name: Standard care
description: Standard care according to guidelines and national regulations
arm group label: SARS-CoV-2 convalescent plasma treatment plus standard care
arm group label: Standard care alone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guillermo E Quintero, Hematologist
phone: 5716030303
phone ext: 1221
email: quiquequintero@yahoo.com.mx
last name: José A De la Hoz, Epidemiologist
phone: 5716030303
phone ext: 1127
email: jose.delahoz@fsfb.org.co
facility: 
contact: 
country: Colombia
responsible party type: Principal Investigator
investigator affiliation: Fundación Santa Fe de Bogota
investigator full name: Guillermo Enrique Quintero-Vega
investigator title: Hematologist
mesh term: COVID-19