<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/NCT04434131</url>
  </required_header>
  <id_info>
    <org_study_id>20-227</org_study_id>
    <nct_id>NCT04434131</nct_id>
  </id_info>
  <brief_title>Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19</brief_title>
  <official_title>Open, Non-comparative Pilot Study to Provide Access to Treatment With Investigational Convalescent Plasma and Measure Antibody Levels in Patients Hospitalized With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of New Mexico</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open label pilot study designed to provide access to treatment with&#xD;
      investigational convalescent plasma and assess the relationship between NAb titers in the&#xD;
      investigational convalescent plasma compared to changes in NAb levels in the recipient in&#xD;
      hospitalized patients with COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary objectives are as follows:&#xD;
&#xD;
        1. To provide access to treatment with investigational convalescent plasma to inpatients&#xD;
           with documented COIVD-19 infection&#xD;
&#xD;
        2. To measure NAb titers in an aliquot of the CP administered, to measure the volume of CP&#xD;
           administered, and determine whether there is a correlation between the NAb dose (in NAb&#xD;
           units/kg body weight, where a unit is the reciprocal of the endpoint NAb titer in the CP&#xD;
           multiplied by the volume in ml) and change or lack of change when comparing&#xD;
           pre-treatment and day one NAb titers.&#xD;
&#xD;
      Secondary, exploratory objectives are as follows:&#xD;
&#xD;
        1. To evaluate the safety of convalescent plasma (CP) administration in hospitalized&#xD;
           COVID-19 patients&#xD;
&#xD;
        2. To evaluate viral shedding of SARSCoV-2 in nasopharyngeal or nasal samples before and on&#xD;
           days 3, 7, and 14 after CP transfusion&#xD;
&#xD;
        3. To perform genomic analysis of the SARS-CoV-2 from patients before and after treatment&#xD;
           with CP transfusion&#xD;
&#xD;
        4. Determine cumulative incidence of disease severity (transfer to ICU, type of respiratory&#xD;
           support, LOS, and mortality)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 28, 2020</start_date>
  <completion_date type="Actual">March 12, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>NAb Dose Titer in the Convalescent Plasma (CP), Pre-treatment, and Day One in Hospitalized Patients With Documented COVID-19 Infection</measure>
    <time_frame>Day of convalescent plasma infusion (day 0) and following day (day 1)</time_frame>
    <description>Neutralizing antibody titer (PRNT 80)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Rapid Deterioration as Evidenced by Increase in Ordinal Score</measure>
    <time_frame>Within 4 hours of transfusion</time_frame>
    <description>World Health Organization ordinal scale, with scores defined as follows: 5, hospitalized, requiring any supplemental oxygen; 6, hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices; 7, hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation; and 8, death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clearance of Viral Shedding of SARS CoV-2 in Nasopharyngeal Samples</measure>
    <time_frame>Day 0,1,3,7 and 14</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Convalescent Plasma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Vitalant from local and national donors following national blood donation guidelines. All subjects receive the convalescent plasma.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Convalescent Plasma</intervention_name>
    <description>Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.</description>
    <arm_group_label>Convalescent Plasma</arm_group_label>
    <other_name>Not appicable</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients must be 18 years of age or older.&#xD;
&#xD;
          2. Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19&#xD;
             SARS-CoV-2 RT-PCR testing. If COVID-19 test results are pending or done at enrolment,&#xD;
             test results must be positive prior to administration of convalescent plasma.&#xD;
&#xD;
          3. Patient (or legally authorized representative, LAR) is willing and able to provide&#xD;
             written informed consent and comply with all protocol requirements.&#xD;
&#xD;
          4. For patients unable to consent, consent by the legally authorized representative (LAR)&#xD;
             may be obtained by phone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female subjects with positive pregnancy test or breastfeeding.&#xD;
&#xD;
          2. Receipt of pooled immunoglobulin in past 30 days.&#xD;
&#xD;
          3. Contraindication to transfusion or history of prior severe allergic reactions to&#xD;
             transfused blood products.&#xD;
&#xD;
          4. On ECMO or in refractory shock at entry&#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>University of New Mexico Health Sciences Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <results_first_submitted>March 15, 2021</results_first_submitted>
  <results_first_submitted_qc>February 8, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 8, 2023</results_first_posted>
  <last_update_submitted>February 8, 2023</last_update_submitted>
  <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of New Mexico</investigator_affiliation>
    <investigator_full_name>Michelle Harkins</investigator_full_name>
    <investigator_title>Division Chief of Pulmonary/ Critical Care/Sleep Medicine</investigator_title>
  </responsible_party>
  <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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 4, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT04434131/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 29, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT04434131/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Single Arm</title>
          <description>The investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Vitalant from local and national donors following national blood donation guidelines. All subjects receive the convalescent plasma.&#xD;
Convalescent Plasma: Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Single Arm</title>
          <description>The investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Vitalant from local and national donors following national blood donation guidelines. All subjects receive the convalescent plasma.&#xD;
Convalescent Plasma: Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52" lower_limit="39" upper_limit="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>NAb Dose Titer in the Convalescent Plasma (CP), Pre-treatment, and Day One in Hospitalized Patients With Documented COVID-19 Infection</title>
        <description>Neutralizing antibody titer (PRNT 80)</description>
        <time_frame>Day of convalescent plasma infusion (day 0) and following day (day 1)</time_frame>
        <population>Participants were hospitalized patients receiving CP and donors were not considered participants of the study. Again, 12 donors contributed to CP but were not enrolled in the study. Mean titer from donor CP obtained from 12 donors.</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>The investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Vitalant from local and national donors following national blood donation guidelines. All subjects receive the convalescent plasma.&#xD;
Convalescent Plasma: Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.</description>
          </group>
        </group_list>
        <measure>
          <title>NAb Dose Titer in the Convalescent Plasma (CP), Pre-treatment, and Day One in Hospitalized Patients With Documented COVID-19 Infection</title>
          <description>Neutralizing antibody titer (PRNT 80)</description>
          <population>Participants were hospitalized patients receiving CP and donors were not considered participants of the study. Again, 12 donors contributed to CP but were not enrolled in the study. Mean titer from donor CP obtained from 12 donors.</population>
          <units>titer</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Donor convalescent plasma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.7" spread="32.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0 (pre-treatment in hospitalized patients)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="390" spread="369"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 (in hospitalized patients)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="413" spread="363"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Rapid Deterioration as Evidenced by Increase in Ordinal Score</title>
        <description>World Health Organization ordinal scale, with scores defined as follows: 5, hospitalized, requiring any supplemental oxygen; 6, hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices; 7, hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation; and 8, death.</description>
        <time_frame>Within 4 hours of transfusion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>The investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Vitalant from local and national donors following national blood donation guidelines. All subjects receive the convalescent plasma.&#xD;
Convalescent Plasma: Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Rapid Deterioration as Evidenced by Increase in Ordinal Score</title>
          <description>World Health Organization ordinal scale, with scores defined as follows: 5, hospitalized, requiring any supplemental oxygen; 6, hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices; 7, hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation; and 8, death.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clearance of Viral Shedding of SARS CoV-2 in Nasopharyngeal Samples</title>
        <time_frame>Day 0,1,3,7 and 14</time_frame>
        <population>Data was not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>The investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Vitalant from local and national donors following national blood donation guidelines. All subjects receive the convalescent plasma.&#xD;
Convalescent Plasma: Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clearance of Viral Shedding of SARS CoV-2 in Nasopharyngeal Samples</title>
          <population>Data was not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>14 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Single Arm</title>
          <description>The investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Vitalant from local and national donors following national blood donation guidelines. All subjects receive the convalescent plasma.&#xD;
Convalescent Plasma: Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Michelle Harkins</name_or_title>
      <organization>University of New Mexico Health Sciences Center</organization>
      <phone>5052724751</phone>
      <email>mharkins@salud.unm.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04434131
org study id: 20-227
nct id: NCT04434131
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This is an open label pilot study designed to provide access to treatment with
      investigational convalescent plasma and assess the relationship between NAb titers in the
      investigational convalescent plasma compared to changes in NAb levels in the recipient in
      hospitalized patients with COVID-19.
Primary objectives are as follows:

        1. To provide access to treatment with investigational convalescent plasma to inpatients
           with documented COIVD-19 infection

        2. To measure NAb titers in an aliquot of the CP administered, to measure the volume of CP
           administered, and determine whether there is a correlation between the NAb dose (in NAb
           units/kg body weight, where a unit is the reciprocal of the endpoint NAb titer in the CP
           multiplied by the volume in ml) and change or lack of change when comparing
           pre-treatment and day one NAb titers.

      Secondary, exploratory objectives are as follows:

        1. To evaluate the safety of convalescent plasma (CP) administration in hospitalized
           COVID-19 patients

        2. To evaluate viral shedding of SARSCoV-2 in nasopharyngeal or nasal samples before and on
           days 3, 7, and 14 after CP transfusion

        3. To perform genomic analysis of the SARS-CoV-2 from patients before and after treatment
           with CP transfusion

        4. Determine cumulative incidence of disease severity (transfer to ICU, type of respiratory
           support, LOS, and mortality)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: NAb Dose Titer in the Convalescent Plasma (CP), Pre-treatment, and Day One in Hospitalized Patients With Documented COVID-19 Infection
time frame: Day of convalescent plasma infusion (day 0) and following day (day 1)
description: Neutralizing antibody titer (PRNT 80)
measure: Number of Participants With Rapid Deterioration as Evidenced by Increase in Ordinal Score
time frame: Within 4 hours of transfusion
description: World Health Organization ordinal scale, with scores defined as follows: 5, hospitalized, requiring any supplemental oxygen; 6, hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices; 7, hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation; and 8, death.
measure: Number of Participants With Clearance of Viral Shedding of SARS CoV-2 in Nasopharyngeal Samples
time frame: Day 0,1,3,7 and 14
arm group label: Convalescent Plasma
arm group type: Experimental
description: The investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Vitalant from local and national donors following national blood donation guidelines. All subjects receive the convalescent plasma.
intervention type: Drug
intervention name: Convalescent Plasma
description: Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.
arm group label: Convalescent Plasma
other name: Not appicable
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of New Mexico
investigator full name: Michelle Harkins
investigator title: Division Chief of Pulmonary/ Critical Care/Sleep Medicine
mesh term: COVID-19
sharing ipd: No
provided document: 
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point of contact: 