<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/NCT04442958</url>
  </required_header>
  <id_info>
    <org_study_id>2020.05.2.14.070</org_study_id>
    <nct_id>NCT04442958</nct_id>
  </id_info>
  <brief_title>Effectiveness of Convalescent Immune Plasma Therapy</brief_title>
  <official_title>Effectiveness of Convalescent Immune Plasma Therapy in Severe COVID-19 Patients With Acute Respiratory Distress Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bagcilar Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bagcilar Training and Research Hospital</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate the safety, improvement of clinical symptoms and&#xD;
      laboratory parameters of convalescent immune plasma treatment in severe Covid-19 patients&#xD;
      with ARDS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to evaluate the safety, improvement of clinical symptoms with&#xD;
      hypoxemia, metabolic and laboratory parameters of patients with convalescent immune plasma&#xD;
      treatment in severe Covid-19 patients followed up in critical care unit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2020</start_date>
  <completion_date type="Actual">June 17, 2020</completion_date>
  <primary_completion_date type="Actual">June 15, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma ferritin level</measure>
    <time_frame>7. day</time_frame>
    <description>Acute phase reactant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lymphocyte count</measure>
    <time_frame>7. day</time_frame>
    <description>Infection markers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>D-Dimer level</measure>
    <time_frame>7. day</time_frame>
    <description>Hypercoagulability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>C-Reactive protein level</measure>
    <time_frame>7. day</time_frame>
    <description>Infection markers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma procalcitonin level</measure>
    <time_frame>7. day</time_frame>
    <description>Infection markers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma fibrinogen level</measure>
    <time_frame>7. day</time_frame>
    <description>Coagulopathy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fractional Inspired Oxygen Level</measure>
    <time_frame>7. day</time_frame>
    <description>Arterial oxygenation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Partial Oxygen Saturation level</measure>
    <time_frame>7. day</time_frame>
    <description>Arterial oxygenation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial Oxygen level</measure>
    <time_frame>7. day</time_frame>
    <description>Arterial oxygenation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <arm_group>
    <arm_group_label>Convalescent Plasma Therapy Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One dose of 200 mL of convalescent ımmune plasma derived from recently recovered donors with the neutralizing antibody titers above 1:640 was transfused to the patients as an addition to standart critical care treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Plasma Therapy Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standart critical care treatment group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Convalescent Immune Plasma</intervention_name>
    <description>One dose of 200 mL of convalescent ımmune plasma derived from recently recovered donors with the neutralizing antibody titers above 1:640 was transfused to the patients as an addition to standart critical care treatment.</description>
    <arm_group_label>Convalescent Plasma Therapy Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria Clinical diagnosis of Covid-19&#xD;
&#xD;
        Exclusion Criteria Age lower than 18 Lower plasma IgA levels PaO2/FiO2 higher than 300 mmHg&#xD;
        SpO2 higher than 90&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Salih SS Sevdi, Md</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istanbul Bagcılar Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul Bagcılar Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34375</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Syndrome</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/NCT04442958
org study id: 2020.05.2.14.070
nct id: NCT04442958
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of the study is to evaluate the safety, improvement of clinical symptoms and
      laboratory parameters of convalescent immune plasma treatment in severe Covid-19 patients
      with ARDS.
The aim of the study is to evaluate the safety, improvement of clinical symptoms with
      hypoxemia, metabolic and laboratory parameters of patients with convalescent immune plasma
      treatment in severe Covid-19 patients followed up in critical care unit.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Plasma ferritin level
time frame: 7. day
description: Acute phase reactant
measure: Lymphocyte count
time frame: 7. day
description: Infection markers
measure: D-Dimer level
time frame: 7. day
description: Hypercoagulability
measure: C-Reactive protein level
time frame: 7. day
description: Infection markers
measure: Plasma procalcitonin level
time frame: 7. day
description: Infection markers
measure: Plasma fibrinogen level
time frame: 7. day
description: Coagulopathy
measure: Fractional Inspired Oxygen Level
time frame: 7. day
description: Arterial oxygenation
measure: Partial Oxygen Saturation level
time frame: 7. day
description: Arterial oxygenation
measure: Arterial Oxygen level
time frame: 7. day
description: Arterial oxygenation
arm group label: Convalescent Plasma Therapy Group
arm group type: Experimental
description: One dose of 200 mL of convalescent ımmune plasma derived from recently recovered donors with the neutralizing antibody titers above 1:640 was transfused to the patients as an addition to standart critical care treatment.
arm group label: Non-Plasma Therapy Group
arm group type: No Intervention
description: Standart critical care treatment group
intervention type: Other
intervention name: Convalescent Immune Plasma
description: One dose of 200 mL of convalescent ımmune plasma derived from recently recovered donors with the neutralizing antibody titers above 1:640 was transfused to the patients as an addition to standart critical care treatment.
arm group label: Convalescent Plasma Therapy Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Salih SS Sevdi, Md
role: Principal Investigator
affiliation: Istanbul Bagcılar Training and Research Hospital
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Syndrome