<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/NCT04438057</url>
  </required_header>
  <id_info>
    <org_study_id>MIDC-CCP</org_study_id>
    <nct_id>NCT04438057</nct_id>
  </id_info>
  <brief_title>Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19</brief_title>
  <official_title>Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Metro Infectious Disease Consultants</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Metro Infectious Disease Consultants</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will provide investigational convalescent plasma for patients infected with the&#xD;
      SARS-CoV-2 with mild to moderate symptoms who meet inclusion criteria as judged by physician&#xD;
      evaluation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will provide investigational convalescent plasma for patients infected with the&#xD;
      SARS-CoV-2 with mild to moderate symptoms who meet inclusion criteria as judged by physician&#xD;
      evaluation.&#xD;
&#xD;
      Following patient enrollment into the study, completion of informed consent and&#xD;
      randomization, the patient will receive one unit of convalescent COVID plasma or standard of&#xD;
      care. The plasma will be infused in an outpatient infusion center by highly trained and&#xD;
      experienced staff. Vitalant will be providing the plasma as per their normal screening and&#xD;
      distribution protocols. Patients will be monitored for safety during the infusion and per&#xD;
      protocol following the infusion for a period of 28 days. Primary efficacy and safety&#xD;
      endpoints will be statistically analyzed and compared between the two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 12, 2020</start_date>
  <completion_date type="Actual">August 12, 2021</completion_date>
  <primary_completion_date type="Actual">August 12, 2020</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>
    <intervention_model_description>Outpatient open label randomized study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Resolution of Symptoms</measure>
    <time_frame>28 days</time_frame>
    <description>a. Time to resolution of symptoms will be defined as time from randomization (day 0) to a successful outcome. c. A successful outcome is defined as symptom improvement of 3 numbers or down to zero on the memory aid for all symptoms noted.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SAEs within 24 hours of plasma infusion</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decrease in Inflammatory Markers</measure>
    <time_frame>28 days</time_frame>
    <description>A 50% decrease at day 28 in C-Reactive Protein (mg/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in Inflammatory Markers</measure>
    <time_frame>28 days</time_frame>
    <description>A 50% decrease at day 28 in D-Dimer (ng/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in Inflammatory Markers</measure>
    <time_frame>28 days</time_frame>
    <description>A 50% decrease at day 28 in Ferritin (ng/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in Inflammatory Markers</measure>
    <time_frame>28 days</time_frame>
    <description>A 50% decrease at day 28 in Lactate Dehydrogenase (U/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization within 28 days</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">103</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patient will receive standard of care therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient will receive convalescent plasma</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CCP</intervention_name>
    <description>Randomized open label study to receive 2:1 CCP to standard of care</description>
    <arm_group_label>Treatment Arm</arm_group_label>
    <other_name>convalescent plasma</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Laboratory confirmed diagnosis of infection with SARS-CoV-2&#xD;
&#xD;
          -  Symptoms of COVID -19 - cough, fever, sore throat, SOB, anosmia, diarrhea, myalgia&#xD;
&#xD;
          -  Symptoms less than 14 days&#xD;
&#xD;
          -  ID Physician determination that the patient does not need hospitalization&#xD;
&#xD;
          -  O2 saturation of &gt;93%&#xD;
&#xD;
          -  Informed consent provided by the patient or healthcare proxy&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Ambulatory Outpatient when informed consent obtained and study drug is administered&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 y/o&#xD;
&#xD;
          -  Patients currently receiving intravenous immunoglobulin&#xD;
&#xD;
          -  Hypercoagulable state - neoplasia, Collagen vascular disease, Myelodysplastic&#xD;
             syndrome, chronic anticoagulation treatment, etc.&#xD;
&#xD;
          -  Need to be hospitalized&#xD;
&#xD;
          -  O2 sat &lt; 93%&#xD;
&#xD;
          -  D-Dimer &gt; 2x normal&#xD;
&#xD;
          -  Chronic oxygen therapy&#xD;
&#xD;
          -  Renal insufficiency with Creatinine clearance &lt; 30&#xD;
&#xD;
          -  Long term care or assisted living facility resident&#xD;
&#xD;
          -  Ongoing usage of hydroxychloroquine for any indication&#xD;
&#xD;
          -  History of blood or plasma transfusion related complications&#xD;
&#xD;
          -  Enrollment into any other investigational drug or device study within the previous 30&#xD;
             days&#xD;
&#xD;
          -  Any drug, chemical or alcohol dependency as determined by the investigator through&#xD;
             history that may affect study procedures and follow up&#xD;
&#xD;
          -  Pregnant or breast feeding&#xD;
&#xD;
          -  Any acute or chronic medical comorbidity, psychiatric, social or other circumstance&#xD;
             that, in the opinion of the investigator, may interfere with study compliance,&#xD;
             completion, or accurate assessment of the study outcomes/safety&#xD;
&#xD;
          -  Admitted to or expected to be admitted to a medical facility&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Metro Infectious Disease Consultants</name>
      <address>
        <city>Burr Ridge</city>
        <state>Illinois</state>
        <zip>60527</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>April 4, 2022</last_update_submitted>
  <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04438057
org study id: MIDC-CCP
nct id: NCT04438057
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will provide investigational convalescent plasma for patients infected with the
      SARS-CoV-2 with mild to moderate symptoms who meet inclusion criteria as judged by physician
      evaluation.
This study will provide investigational convalescent plasma for patients infected with the
      SARS-CoV-2 with mild to moderate symptoms who meet inclusion criteria as judged by physician
      evaluation.

      Following patient enrollment into the study, completion of informed consent and
      randomization, the patient will receive one unit of convalescent COVID plasma or standard of
      care. The plasma will be infused in an outpatient infusion center by highly trained and
      experienced staff. Vitalant will be providing the plasma as per their normal screening and
      distribution protocols. Patients will be monitored for safety during the infusion and per
      protocol following the infusion for a period of 28 days. Primary efficacy and safety
      endpoints will be statistically analyzed and compared between the two groups.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Outpatient open label randomized study
primary purpose: Treatment
masking: None (Open Label)
measure: Time to Resolution of Symptoms
time frame: 28 days
description: a. Time to resolution of symptoms will be defined as time from randomization (day 0) to a successful outcome. c. A successful outcome is defined as symptom improvement of 3 numbers or down to zero on the memory aid for all symptoms noted.
measure: SAEs within 24 hours of plasma infusion
time frame: 28 days
measure: Decrease in Inflammatory Markers
time frame: 28 days
description: A 50% decrease at day 28 in C-Reactive Protein (mg/mL)
measure: Decrease in Inflammatory Markers
time frame: 28 days
description: A 50% decrease at day 28 in D-Dimer (ng/mL)
measure: Decrease in Inflammatory Markers
time frame: 28 days
description: A 50% decrease at day 28 in Ferritin (ng/mL)
measure: Decrease in Inflammatory Markers
time frame: 28 days
description: A 50% decrease at day 28 in Lactate Dehydrogenase (U/L)
measure: Hospitalization within 28 days
time frame: 28 days
arm group label: Standard of Care
arm group type: No Intervention
description: Patient will receive standard of care therapy.
arm group label: Treatment Arm
arm group type: Active Comparator
description: Patient will receive convalescent plasma
intervention type: Biological
intervention name: CCP
description: Randomized open label study to receive 2:1 CCP to standard of care
arm group label: Treatment Arm
other name: convalescent plasma
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No