<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/NCT04432272</url>
  </required_header>
  <id_info>
    <org_study_id>2020-198</org_study_id>
    <nct_id>NCT04432272</nct_id>
  </id_info>
  <brief_title>ANTIBODY-LEVEL BASED ANALYSIS OF COVID-19 CONVALESCENT SERUM (ABACCuS)</brief_title>
  <acronym>ABACCuS</acronym>
  <official_title>ANTIBODY-LEVEL BASED ANALYSIS OF COVID-19 CONVALESCENT SERUM (ABACCuS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>William Beaumont Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>William Beaumont Hospitals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to evaluate the safety and effectiveness of Coronavirus-90&#xD;
      (COVID-19) convalescent plasma for the treatment of COVID-19. Plasma is the liquid part of&#xD;
      blood that is left when all the blood cells have been removed. Convalescent means it is taken&#xD;
      from people who were infected with COVID-19 and recovered. The use of this blood product to&#xD;
      treat COVID-19 is investigational, which means the U.S. Food and Drug Administration has not&#xD;
      yet approved it to be sold commercially. This is a human blood product collected by licensed&#xD;
      blood banks. Donors of COVID-19 convalescent plasma must meet all standard blood donor&#xD;
      criteria and must also meet all criteria set by the FDA for being a donor of COVID-19&#xD;
      convalescent plasma.&#xD;
&#xD;
      A total of 500 patients will take part in the study at 8 hospitals within Beaumont. Similar&#xD;
      studies are being done at other centers, but they are not directly related to this study.&#xD;
&#xD;
      Participants will be assigned to a study group depending on how sick they are.&#xD;
&#xD;
        -  Group A: Those who require more than 6 liters (L) of supplemental oxygen but are not on&#xD;
           a ventilator&#xD;
&#xD;
        -  Group B: Those who require a ventilator to preserve their life.&#xD;
&#xD;
      Both groups will receive one unit (approximately 200ml or just under 1 cup) of COVID&#xD;
      convalescent plasma. The transfusion will be given over about 30 minutes via an IV. Blood&#xD;
      samples will be taken prior to and one hour after the transfusion to measure participant&#xD;
      antibodies against Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV-2) and a&#xD;
      nasopharyngeal swab (deep in the nostril) will be taken to test for presence of the&#xD;
      SARS-CoV-2 virus. One hour after the transfusion a blood sample will be taken to measure&#xD;
      antibody levels to determine if the plasma caused the antibody level to rise. Similarly,&#xD;
      blood samples will be taken to measure antibodies against SARS-CoV-2 and a nasopharyngeal&#xD;
      swab will be taken to test for presence of the SARS-CoV-2 virus 1, 3 and every 7 days after&#xD;
      the transfusion while the participant is in the hospital The participant's final health&#xD;
      status will be determined on day 28. Hospital records will be monitored for 90 days after&#xD;
      discharge to determine if the participant is readmitted to the hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial will evaluate the efficacy and safety of SARS-CoV-2 convalescent plasma as&#xD;
      treatment for confirmed COVID-19 respiratory disease (as defined in the inclusion criteria).&#xD;
      Participants in both group A and group B will receive COVID-19 convalescent plasma. Group A&#xD;
      will include hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms,&#xD;
      requiring &gt;6 L of oxygen to maintain O2 saturation &gt;92%. Patient may not require intubation,&#xD;
      and may be admitted for no longer than 14 days. Group B will include hospitalized COVID-19&#xD;
      patients ages ≥18 years requiring intubation. Patients may be enrolled in group A within 14&#xD;
      days of admission to the hospital and may be enrolled in group B at any time after&#xD;
      intubation. A total of 300 eligible subjects with significant oxygen requirements and 200&#xD;
      eligible subjects who require intubation will be included in the study. They will receive&#xD;
      convalescent plasma from either a patient who has recovered from COVID-19 or from an&#xD;
      asymptomatic carrier with confirmed Immunoglobulin-G (IgG) antibodies against SARS-CoV-2.&#xD;
      Subjects will not be randomized. The amount of anti-SARS-CoV-2 IgG and Immunoglobulin-A (IgA)&#xD;
      antibodies in any unit of plasma will not be known when the unit is assigned to the patient.&#xD;
      This will allow us to examine the relationship between the amount of anti-SARS-CoV-2 antibody&#xD;
      and outcomes. Analysis will be based on measurement of optical density of the IgG level in&#xD;
      the unit of plasma the patient is randomly supplied by the blood bank. While investigators&#xD;
      and patients will be aware the patient is receiving a unit of COVID-19 convalescent plasma,&#xD;
      both the investigators and the patients will be blinded to the antibody content of that unit.&#xD;
&#xD;
      COVID-19 convalescent plasma (1 unit; ~200mL) will be produced by a blood bank licensed to&#xD;
      produce plasma using standard screening and safety procedures. The product may be procured&#xD;
      from patients who have: 1) been symptom free for 14 days and screen negative via&#xD;
      nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never&#xD;
      had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology&#xD;
      test deemed to be of acceptable quality and fitting the current guidance by the FDA.&#xD;
&#xD;
      Participants at the eight Michigan hospitals comprising the Beaumont Health system may be&#xD;
      eligible to participate. Study oversight and coordination will occur centrally, from the&#xD;
      Infectious Disease Research Department at Beaumont's Royal Oak campus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The EUA for CCP was updated by FDA, stipulating that only high titer units be used. This study&#xD;
    required untitered units. The study became infeasible&#xD;
  </why_stopped>
  <start_date type="Actual">July 16, 2020</start_date>
  <completion_date type="Actual">November 28, 2020</completion_date>
  <primary_completion_date type="Actual">November 13, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Prospective, single health system, non-randomized, open-label study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No parties blinded as to receipt of study article. Participant, care provider and investigator blinded to actual antibody concentration in unit of plasma provided.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Avoidance of Intubation at 28 Days (Group A)</measure>
    <time_frame>28 days</time_frame>
    <description>Count of group A participants (non-intubated participants requiring &gt;6 L supplemental oxygen to maintain oxygen saturation &gt;92% at time of study entry and who are admitted &lt;14 days) who remain un-intubated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality (Group B)</measure>
    <time_frame>28 days</time_frame>
    <description>Count of group B participants (participants who are intubated at study entry) who die</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardio-circulatory Arrest</measure>
    <time_frame>28 days</time_frame>
    <description>Count of participants who experienced cardio-circulatory arrest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Outcome at 28 Days</measure>
    <time_frame>28 days</time_frame>
    <description>Patient Outcome as assessed on a 7-point ordinal scale, where 1= Not hospitalized, no limitations on activities, 2 =Not hospitalized, limitation on activities, 3= Hospitalized, not requiring supplemental oxygen, 4 =Hospitalized, requiring supplemental oxygen , 5 = Hospitalized, on non-invasive ventilation or high flow oxygen devices, 6 = Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), 7=Deceased. A lower number indicates a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal Failure</measure>
    <time_frame>28 days</time_frame>
    <description>Count of participants who develop or experience worsened renal failure as defined by RIFLE criteria, a 5-point scale where the categories are labeled: Risk-Injury-Failure-Loss-End stage renal disease, with Risk being the least severe and End stage renal disease being the most severe. The criteria for determination of stage are factors of serum creatinine and urine output. Numbers of participants worsening one or more RIFLE stages will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver Failure</measure>
    <time_frame>28 days</time_frame>
    <description>Count of participants who develop or experience worsened liver failure as measured by elevation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels to 5x the upper limit of normal or significant worsening of current liver failure with rise in transaminases of &gt;25%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine Storm</measure>
    <time_frame>28 days</time_frame>
    <description>Count of participants who develop cytokine storm as measured by elevated markers of inflammation (elevated D-dimer, hypofibrinogenemia, hyperferritinemia), evidence of acute respiratory distress syndrome (ARDS) measured by imaging findings and mechanical ventilator requirements, and/or continuous fever (≥ 38.1 ° Celsius unremitting)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Support</measure>
    <time_frame>28 days</time_frame>
    <description>Count of participants who require respiratory support in each of the following categories: nasal cannula, high flow nasal canula, non-rebreather mask, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or intubation. Patients may receive more than one type of support during their hospital stay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vasopressor Medication Support</measure>
    <time_frame>28 days</time_frame>
    <description>Count of participants who received pressor drugs, as ordered by treating physicians</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ICU Length of Stay</measure>
    <time_frame>28 days</time_frame>
    <description>Length of ICU stay in days, for participants who entered ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive Care Unit (ICU) Mortality</measure>
    <time_frame>28 days</time_frame>
    <description>Count of patients admitted to the ICU who die in ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>28 days</time_frame>
    <description>Length of hospital stay in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilator Free Days</measure>
    <time_frame>28 days</time_frame>
    <description>Number of ventilator-free hospitalized days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intubation Duration</measure>
    <time_frame>28 days</time_frame>
    <description>Length of intubation, measured in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission</measure>
    <time_frame>90 days</time_frame>
    <description>Count of participants readmitted to hospital following index procedure hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Anti-SARS-CoV-2 IgG</measure>
    <time_frame>During hospitalization, a maximum of 28 days</time_frame>
    <description>Count of participants positive for serum anti-SARS-CoV-2 IgG as assayed by the EUROIMMUN Anti-SARS-CoV-2 assay, evaluated semi-quantitatively by calculation of a ratio of the extinction of the patient sample over the extinction of a calibrator. This ratio is interpreted as: ratio &lt; 0.8 is negative, ratio ≥ 0.8 to &lt;1.0 is considered borderline, and ratio ≥ 1.1 is positive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SARS-CoV-2 RNA</measure>
    <time_frame>During hospitalization, a maximum of 28 days</time_frame>
    <description>Count of participants with presence of SARS-CoV-2 RNA detected by reverse transcription polymerase chain reaction (RT-PCR) tested nasopharyngeal swabs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality (Group A)</measure>
    <time_frame>28 days</time_frame>
    <description>Count of group A participants (non-intubated participants requiring &gt;6 L supplemental oxygen to maintain oxygen saturation &gt;92% at time of study entry and admitted &lt;14 days) who die</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From Transfusion to End of Ventilator Support (Group B)</measure>
    <time_frame>During hospitalization, a maximum of 28 days</time_frame>
    <description>Number of days from transfusion date until end of ventilator support for surviving group B participants (participants who are intubated at study entry)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>COVID-19</condition>
  <condition>Severe Acute Respiratory Syndrome (SARS)</condition>
  <condition>Coronavirus Infections</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring &gt;6 L of oxygen to maintain oxygen saturation &gt;92%. Patient may not require intubation, and may be admitted for no longer than 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hospitalized COVID-19 patients ages ≥18 years requiring intubation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>COVID-19 convalescent plasma</intervention_name>
    <description>Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must be 18 years of age or older.&#xD;
&#xD;
          -  Hospitalized with confirmed COVID-19 infection via COVID-19 SARS-CoV-2&#xD;
             Reverse-transcription polymerase chain reaction (RT-PCR) testing.&#xD;
&#xD;
          -  Symptoms consistent with COVID-19 infection (fever, acute onset cough, shortness of&#xD;
             breath) at time of screening.&#xD;
&#xD;
          -  Patient requires &gt;6 L nasal cannula oxygen (Group A) or intubated (Group B).&#xD;
&#xD;
          -  Patient (or their legal authorized representative) is willing and able to provide&#xD;
             written informed consent and comply with all protocol requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For patients in Group A admitted for &gt;14 days&#xD;
&#xD;
          -  Female subjects with positive pregnancy test, breastfeeding, or planning to become&#xD;
             --pregnant or breastfeed during the study period.&#xD;
&#xD;
          -  Receipt of pooled immunoglobulin in past 30 days.&#xD;
&#xD;
          -  Contraindication to transfusion or history of prior reactions to transfusion blood&#xD;
             products.&#xD;
&#xD;
          -  Patients currently undergoing cancer treatment or those who are presently&#xD;
             immunocompromised.&#xD;
&#xD;
          -  Patient who in the opinion of the investigator will not be a good study candidate.&#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>Matthew Sims, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beaumont Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>William Beaumont Hospital</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <results_first_submitted>November 12, 2021</results_first_submitted>
  <results_first_submitted_qc>November 12, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 22, 2021</results_first_posted>
  <last_update_submitted>March 7, 2022</last_update_submitted>
  <last_update_submitted_qc>March 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>William Beaumont Hospitals</investigator_affiliation>
    <investigator_full_name>Matthew Sims, MD, PhD</investigator_full_name>
    <investigator_title>Director Infectious Disease Research, Beaumont Health; Professor of Internal Medicine and Foundational Medical Studies, OUWB School of Medicine</investigator_title>
  </responsible_party>
  <keyword>therapeutic treatment</keyword>
  <keyword>COVID-19 convalescent plasma</keyword>
  <keyword>anti-SARS-CoV-2 antibody</keyword>
  <keyword>IgA</keyword>
  <keyword>IgG</keyword>
  <keyword>COVID-19 pandemic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Severe Acute Respiratory Syndrome</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>August 26, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT04432272/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group A</title>
          <description>Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring &gt;6 L of oxygen to maintain oxygen saturation &gt;92%. Patient may not require intubation, and may be admitted for no longer than 14 days.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
        </group>
        <group group_id="P2">
          <title>Group B</title>
          <description>Hospitalized COVID-19 patients ages ≥18 years requiring intubation.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group A</title>
          <description>Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring &gt;6 L of oxygen to maintain oxygen saturation &gt;92%. Patient may not require intubation, and may be admitted for no longer than 14 days.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
        </group>
        <group group_id="B2">
          <title>Group B</title>
          <description>Hospitalized COVID-19 patients ages ≥18 years requiring intubation.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="71"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72.95" spread="10.37"/>
                    <measurement group_id="B2" value="62.83" spread="13.53"/>
                    <measurement group_id="B3" value="68.96" spread="12.65"/>
                  </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="13"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                  </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="43"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Avoidance of Intubation at 28 Days (Group A)</title>
        <description>Count of group A participants (non-intubated participants requiring &gt;6 L supplemental oxygen to maintain oxygen saturation &gt;92% at time of study entry and who are admitted &lt;14 days) who remain un-intubated</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring &gt;6 L of oxygen to maintain oxygen saturation &gt;92%. Patient may not require intubation, and may be admitted for no longer than 14 days.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
        </group_list>
        <measure>
          <title>Avoidance of Intubation at 28 Days (Group A)</title>
          <description>Count of group A participants (non-intubated participants requiring &gt;6 L supplemental oxygen to maintain oxygen saturation &gt;92% at time of study entry and who are admitted &lt;14 days) who remain un-intubated</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="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mortality (Group B)</title>
        <description>Count of group B participants (participants who are intubated at study entry) who die</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group B</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years requiring intubation.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
        </group_list>
        <measure>
          <title>Mortality (Group B)</title>
          <description>Count of group B participants (participants who are intubated at study entry) who die</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="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cardio-circulatory Arrest</title>
        <description>Count of participants who experienced cardio-circulatory arrest</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring &gt;6 L of oxygen to maintain oxygen saturation &gt;92%. Patient may not require intubation, and may be admitted for no longer than 14 days.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years requiring intubation.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
        </group_list>
        <measure>
          <title>Cardio-circulatory Arrest</title>
          <description>Count of participants who experienced cardio-circulatory arrest</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="43"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Outcome at 28 Days</title>
        <description>Patient Outcome as assessed on a 7-point ordinal scale, where 1= Not hospitalized, no limitations on activities, 2 =Not hospitalized, limitation on activities, 3= Hospitalized, not requiring supplemental oxygen, 4 =Hospitalized, requiring supplemental oxygen , 5 = Hospitalized, on non-invasive ventilation or high flow oxygen devices, 6 = Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), 7=Deceased. A lower number indicates a better outcome</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring &gt;6 L of oxygen to maintain oxygen saturation &gt;92%. Patient may not require intubation, and may be admitted for no longer than 14 days.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years requiring intubation.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Outcome at 28 Days</title>
          <description>Patient Outcome as assessed on a 7-point ordinal scale, where 1= Not hospitalized, no limitations on activities, 2 =Not hospitalized, limitation on activities, 3= Hospitalized, not requiring supplemental oxygen, 4 =Hospitalized, requiring supplemental oxygen , 5 = Hospitalized, on non-invasive ventilation or high flow oxygen devices, 6 = Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), 7=Deceased. A lower number indicates a better outcome</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="43"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1= Not hospitalized, no limitations on activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 =Not hospitalized, limitation on activities</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3= Hospitalized, not requiring supplemental oxygen</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 =Hospitalized, requiring supplemental oxygen</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5 = Hospitalized, on non-invasive ventilation or high flow oxygen devices</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6 = Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>7=Deceased</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Renal Failure</title>
        <description>Count of participants who develop or experience worsened renal failure as defined by RIFLE criteria, a 5-point scale where the categories are labeled: Risk-Injury-Failure-Loss-End stage renal disease, with Risk being the least severe and End stage renal disease being the most severe. The criteria for determination of stage are factors of serum creatinine and urine output. Numbers of participants worsening one or more RIFLE stages will be reported.</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring &gt;6 L of oxygen to maintain oxygen saturation &gt;92%. Patient may not require intubation, and may be admitted for no longer than 14 days.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years requiring intubation.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
        </group_list>
        <measure>
          <title>Renal Failure</title>
          <description>Count of participants who develop or experience worsened renal failure as defined by RIFLE criteria, a 5-point scale where the categories are labeled: Risk-Injury-Failure-Loss-End stage renal disease, with Risk being the least severe and End stage renal disease being the most severe. The criteria for determination of stage are factors of serum creatinine and urine output. Numbers of participants worsening one or more RIFLE stages will be reported.</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="43"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Liver Failure</title>
        <description>Count of participants who develop or experience worsened liver failure as measured by elevation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels to 5x the upper limit of normal or significant worsening of current liver failure with rise in transaminases of &gt;25%</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring &gt;6 L of oxygen to maintain oxygen saturation &gt;92%. Patient may not require intubation, and may be admitted for no longer than 14 days.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years requiring intubation.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
        </group_list>
        <measure>
          <title>Liver Failure</title>
          <description>Count of participants who develop or experience worsened liver failure as measured by elevation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels to 5x the upper limit of normal or significant worsening of current liver failure with rise in transaminases of &gt;25%</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="43"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cytokine Storm</title>
        <description>Count of participants who develop cytokine storm as measured by elevated markers of inflammation (elevated D-dimer, hypofibrinogenemia, hyperferritinemia), evidence of acute respiratory distress syndrome (ARDS) measured by imaging findings and mechanical ventilator requirements, and/or continuous fever (≥ 38.1 ° Celsius unremitting)</description>
        <time_frame>28 days</time_frame>
        <population>Data not available for 10 Group A participants and 8 group B participants</population>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring &gt;6 L of oxygen to maintain oxygen saturation &gt;92%. Patient may not require intubation, and may be admitted for no longer than 14 days.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years requiring intubation.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
        </group_list>
        <measure>
          <title>Cytokine Storm</title>
          <description>Count of participants who develop cytokine storm as measured by elevated markers of inflammation (elevated D-dimer, hypofibrinogenemia, hyperferritinemia), evidence of acute respiratory distress syndrome (ARDS) measured by imaging findings and mechanical ventilator requirements, and/or continuous fever (≥ 38.1 ° Celsius unremitting)</description>
          <population>Data not available for 10 Group A participants and 8 group B participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Respiratory Support</title>
        <description>Count of participants who require respiratory support in each of the following categories: nasal cannula, high flow nasal canula, non-rebreather mask, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or intubation. Patients may receive more than one type of support during their hospital stay.</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring &gt;6 L of oxygen to maintain oxygen saturation &gt;92%. Patient may not require intubation, and may be admitted for no longer than 14 days.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years requiring intubation.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
        </group_list>
        <measure>
          <title>Respiratory Support</title>
          <description>Count of participants who require respiratory support in each of the following categories: nasal cannula, high flow nasal canula, non-rebreather mask, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or intubation. Patients may receive more than one type of support during their hospital stay.</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="43"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ventilator</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coldflow</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CPAP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BiPAP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-rebreather mask</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nasal cannula</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High flow nasal cannula</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vasopressor Medication Support</title>
        <description>Count of participants who received pressor drugs, as ordered by treating physicians</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring &gt;6 L of oxygen to maintain oxygen saturation &gt;92%. Patient may not require intubation, and may be admitted for no longer than 14 days.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years requiring intubation.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
        </group_list>
        <measure>
          <title>Vasopressor Medication Support</title>
          <description>Count of participants who received pressor drugs, as ordered by treating physicians</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="43"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of ICU Length of Stay</title>
        <description>Length of ICU stay in days, for participants who entered ICU</description>
        <time_frame>28 days</time_frame>
        <population>Analysis population is those participants in each group that entered the ICU</population>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring &gt;6 L of oxygen to maintain oxygen saturation &gt;92%. Patient may not require intubation, and may be admitted for no longer than 14 days.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years requiring intubation.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
        </group_list>
        <measure>
          <title>Length of ICU Length of Stay</title>
          <description>Length of ICU stay in days, for participants who entered ICU</description>
          <population>Analysis population is those participants in each group that entered the ICU</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.59" spread="10.16"/>
                    <measurement group_id="O2" value="22.12" spread="10.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intensive Care Unit (ICU) Mortality</title>
        <description>Count of patients admitted to the ICU who die in ICU</description>
        <time_frame>28 days</time_frame>
        <population>Data was not collected or analyzed for this outcome</population>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring &gt;6 L of oxygen to maintain oxygen saturation &gt;92%. Patient may not require intubation, and may be admitted for no longer than 14 days.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years requiring intubation.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
        </group_list>
        <measure>
          <title>Intensive Care Unit (ICU) Mortality</title>
          <description>Count of patients admitted to the ICU who die in ICU</description>
          <population>Data was not collected or analyzed for this outcome</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Length of Stay</title>
        <description>Length of hospital stay in days</description>
        <time_frame>28 days</time_frame>
        <population>Data not available for 1 Group B participants</population>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring &gt;6 L of oxygen to maintain oxygen saturation &gt;92%. Patient may not require intubation, and may be admitted for no longer than 14 days.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years requiring intubation.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Length of Stay</title>
          <description>Length of hospital stay in days</description>
          <population>Data not available for 1 Group B participants</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.63" spread="9.83"/>
                    <measurement group_id="O2" value="26.41" spread="11.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ventilator Free Days</title>
        <description>Number of ventilator-free hospitalized days</description>
        <time_frame>28 days</time_frame>
        <population>Data available in Group A for 8 of 15 participants who were intubated, and in Group B for 7 of 15 participants who were intubated</population>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring &gt;6 L of oxygen to maintain oxygen saturation &gt;92%. Patient may not require intubation, and may be admitted for no longer than 14 days.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years requiring intubation.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
        </group_list>
        <measure>
          <title>Ventilator Free Days</title>
          <description>Number of ventilator-free hospitalized days</description>
          <population>Data available in Group A for 8 of 15 participants who were intubated, and in Group B for 7 of 15 participants who were intubated</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.13" spread="12.64"/>
                    <measurement group_id="O2" value="14.23" spread="14.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intubation Duration</title>
        <description>Length of intubation, measured in days</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring &gt;6 L of oxygen to maintain oxygen saturation &gt;92%. Patient may not require intubation, and may be admitted for no longer than 14 days.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years requiring intubation.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
        </group_list>
        <measure>
          <title>Intubation Duration</title>
          <description>Length of intubation, measured in days</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.12" spread="6.23"/>
                    <measurement group_id="O2" value="13.93" spread="9.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Readmission</title>
        <description>Count of participants readmitted to hospital following index procedure hospital discharge</description>
        <time_frame>90 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring &gt;6 L of oxygen to maintain oxygen saturation &gt;92%. Patient may not require intubation, and may be admitted for no longer than 14 days.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years requiring intubation.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
        </group_list>
        <measure>
          <title>Readmission</title>
          <description>Count of participants readmitted to hospital following index procedure hospital discharge</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="43"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Anti-SARS-CoV-2 IgG</title>
        <description>Count of participants positive for serum anti-SARS-CoV-2 IgG as assayed by the EUROIMMUN Anti-SARS-CoV-2 assay, evaluated semi-quantitatively by calculation of a ratio of the extinction of the patient sample over the extinction of a calibrator. This ratio is interpreted as: ratio &lt; 0.8 is negative, ratio ≥ 0.8 to &lt;1.0 is considered borderline, and ratio ≥ 1.1 is positive.</description>
        <time_frame>During hospitalization, a maximum of 28 days</time_frame>
        <population>A change in the Emergency Use Authorization for plasma transfusion during COVID-19 occurred during the study. Untitered plasma was no longer available. Thus, data was not analyzed for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring &gt;6 L of oxygen to maintain oxygen saturation &gt;92%. Patient may not require intubation, and may be admitted for no longer than 14 days.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years requiring intubation.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Anti-SARS-CoV-2 IgG</title>
          <description>Count of participants positive for serum anti-SARS-CoV-2 IgG as assayed by the EUROIMMUN Anti-SARS-CoV-2 assay, evaluated semi-quantitatively by calculation of a ratio of the extinction of the patient sample over the extinction of a calibrator. This ratio is interpreted as: ratio &lt; 0.8 is negative, ratio ≥ 0.8 to &lt;1.0 is considered borderline, and ratio ≥ 1.1 is positive.</description>
          <population>A change in the Emergency Use Authorization for plasma transfusion during COVID-19 occurred during the study. Untitered plasma was no longer available. Thus, data was not analyzed for this outcome.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>SARS-CoV-2 RNA</title>
        <description>Count of participants with presence of SARS-CoV-2 RNA detected by reverse transcription polymerase chain reaction (RT-PCR) tested nasopharyngeal swabs.</description>
        <time_frame>During hospitalization, a maximum of 28 days</time_frame>
        <population>Data not available for 4 out of the 43 Group A participants. Data not available for 3 out of the 28 Group B participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring &gt;6 L of oxygen to maintain oxygen saturation &gt;92%. Patient may not require intubation, and may be admitted for no longer than 14 days.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years requiring intubation.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
        </group_list>
        <measure>
          <title>SARS-CoV-2 RNA</title>
          <description>Count of participants with presence of SARS-CoV-2 RNA detected by reverse transcription polymerase chain reaction (RT-PCR) tested nasopharyngeal swabs.</description>
          <population>Data not available for 4 out of the 43 Group A participants. Data not available for 3 out of the 28 Group B participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mortality (Group A)</title>
        <description>Count of group A participants (non-intubated participants requiring &gt;6 L supplemental oxygen to maintain oxygen saturation &gt;92% at time of study entry and admitted &lt;14 days) who die</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring &gt;6 L of oxygen to maintain oxygen saturation &gt;92%. Patient may not require intubation, and may be admitted for no longer than 14 days.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
        </group_list>
        <measure>
          <title>Mortality (Group A)</title>
          <description>Count of group A participants (non-intubated participants requiring &gt;6 L supplemental oxygen to maintain oxygen saturation &gt;92% at time of study entry and admitted &lt;14 days) who die</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="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Transfusion to End of Ventilator Support (Group B)</title>
        <description>Number of days from transfusion date until end of ventilator support for surviving group B participants (participants who are intubated at study entry)</description>
        <time_frame>During hospitalization, a maximum of 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group B</title>
            <description>Hospitalized COVID-19 patients ages ≥18 years requiring intubation.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Transfusion to End of Ventilator Support (Group B)</title>
          <description>Number of days from transfusion date until end of ventilator support for surviving group B participants (participants who are intubated at study entry)</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.25" spread="5.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>28 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Group A</title>
          <description>Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring &gt;6 L of oxygen to maintain oxygen saturation &gt;92%. Patient may not require intubation, and may be admitted for no longer than 14 days.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
        </group>
        <group group_id="E2">
          <title>Group B</title>
          <description>Hospitalized COVID-19 patients ages ≥18 years requiring intubation.&#xD;
COVID-19 convalescent plasma: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Bleeding or low hemoglobin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardio-circulatory arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neurological</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="29" subjects_affected="21" subjects_at_risk="43"/>
                <counts group_id="E2" events="16" subjects_affected="13" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Bleeding</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Low hemaglobin</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deep right ear pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Minor allergic reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>pneumomediastinum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Anterior rectal tear</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <limitations_and_caveats>Early termination due to changes in the Emergency Use Authorization for plasma during COVID-19. All plasma was labeled either low titer or high titer. The protocol required untitered plasma be used, which resulted in inability to complete the study and early termination.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Matthew Sims, MD</name_or_title>
      <organization>Beaumont Hospitals</organization>
      <phone>248-551-0027</phone>
      <email>matthew.sims@beaumont.org</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/NCT04432272
org study id: 2020-198
nct id: NCT04432272
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The goal of this study is to evaluate the safety and effectiveness of Coronavirus-90
      (COVID-19) convalescent plasma for the treatment of COVID-19. Plasma is the liquid part of
      blood that is left when all the blood cells have been removed. Convalescent means it is taken
      from people who were infected with COVID-19 and recovered. The use of this blood product to
      treat COVID-19 is investigational, which means the U.S. Food and Drug Administration has not
      yet approved it to be sold commercially. This is a human blood product collected by licensed
      blood banks. Donors of COVID-19 convalescent plasma must meet all standard blood donor
      criteria and must also meet all criteria set by the FDA for being a donor of COVID-19
      convalescent plasma.

      A total of 500 patients will take part in the study at 8 hospitals within Beaumont. Similar
      studies are being done at other centers, but they are not directly related to this study.

      Participants will be assigned to a study group depending on how sick they are.

        -  Group A: Those who require more than 6 liters (L) of supplemental oxygen but are not on
           a ventilator

        -  Group B: Those who require a ventilator to preserve their life.

      Both groups will receive one unit (approximately 200ml or just under 1 cup) of COVID
      convalescent plasma. The transfusion will be given over about 30 minutes via an IV. Blood
      samples will be taken prior to and one hour after the transfusion to measure participant
      antibodies against Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV-2) and a
      nasopharyngeal swab (deep in the nostril) will be taken to test for presence of the
      SARS-CoV-2 virus. One hour after the transfusion a blood sample will be taken to measure
      antibody levels to determine if the plasma caused the antibody level to rise. Similarly,
      blood samples will be taken to measure antibodies against SARS-CoV-2 and a nasopharyngeal
      swab will be taken to test for presence of the SARS-CoV-2 virus 1, 3 and every 7 days after
      the transfusion while the participant is in the hospital The participant's final health
      status will be determined on day 28. Hospital records will be monitored for 90 days after
      discharge to determine if the participant is readmitted to the hospital.
This trial will evaluate the efficacy and safety of SARS-CoV-2 convalescent plasma as
      treatment for confirmed COVID-19 respiratory disease (as defined in the inclusion criteria).
      Participants in both group A and group B will receive COVID-19 convalescent plasma. Group A
      will include hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms,
      requiring >6 L of oxygen to maintain O2 saturation >92%. Patient may not require intubation,
      and may be admitted for no longer than 14 days. Group B will include hospitalized COVID-19
      patients ages ≥18 years requiring intubation. Patients may be enrolled in group A within 14
      days of admission to the hospital and may be enrolled in group B at any time after
      intubation. A total of 300 eligible subjects with significant oxygen requirements and 200
      eligible subjects who require intubation will be included in the study. They will receive
      convalescent plasma from either a patient who has recovered from COVID-19 or from an
      asymptomatic carrier with confirmed Immunoglobulin-G (IgG) antibodies against SARS-CoV-2.
      Subjects will not be randomized. The amount of anti-SARS-CoV-2 IgG and Immunoglobulin-A (IgA)
      antibodies in any unit of plasma will not be known when the unit is assigned to the patient.
      This will allow us to examine the relationship between the amount of anti-SARS-CoV-2 antibody
      and outcomes. Analysis will be based on measurement of optical density of the IgG level in
      the unit of plasma the patient is randomly supplied by the blood bank. While investigators
      and patients will be aware the patient is receiving a unit of COVID-19 convalescent plasma,
      both the investigators and the patients will be blinded to the antibody content of that unit.

      COVID-19 convalescent plasma (1 unit; ~200mL) will be produced by a blood bank licensed to
      produce plasma using standard screening and safety procedures. The product may be procured
      from patients who have: 1) been symptom free for 14 days and screen negative via
      nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never
      had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology
      test deemed to be of acceptable quality and fitting the current guidance by the FDA.

      Participants at the eight Michigan hospitals comprising the Beaumont Health system may be
      eligible to participate. Study oversight and coordination will occur centrally, from the
      Infectious Disease Research Department at Beaumont's Royal Oak campus.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, single health system, non-randomized, open-label study.
primary purpose: Treatment
masking: None (Open Label)
masking description: No parties blinded as to receipt of study article. Participant, care provider and investigator blinded to actual antibody concentration in unit of plasma provided.
measure: Avoidance of Intubation at 28 Days (Group A)
time frame: 28 days
description: Count of group A participants (non-intubated participants requiring >6 L supplemental oxygen to maintain oxygen saturation >92% at time of study entry and who are admitted <14 days) who remain un-intubated
measure: Mortality (Group B)
time frame: 28 days
description: Count of group B participants (participants who are intubated at study entry) who die
measure: Cardio-circulatory Arrest
time frame: 28 days
description: Count of participants who experienced cardio-circulatory arrest
measure: Patient Outcome at 28 Days
time frame: 28 days
description: Patient Outcome as assessed on a 7-point ordinal scale, where 1= Not hospitalized, no limitations on activities, 2 =Not hospitalized, limitation on activities, 3= Hospitalized, not requiring supplemental oxygen, 4 =Hospitalized, requiring supplemental oxygen , 5 = Hospitalized, on non-invasive ventilation or high flow oxygen devices, 6 = Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), 7=Deceased. A lower number indicates a better outcome
measure: Renal Failure
time frame: 28 days
description: Count of participants who develop or experience worsened renal failure as defined by RIFLE criteria, a 5-point scale where the categories are labeled: Risk-Injury-Failure-Loss-End stage renal disease, with Risk being the least severe and End stage renal disease being the most severe. The criteria for determination of stage are factors of serum creatinine and urine output. Numbers of participants worsening one or more RIFLE stages will be reported.
measure: Liver Failure
time frame: 28 days
description: Count of participants who develop or experience worsened liver failure as measured by elevation of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels to 5x the upper limit of normal or significant worsening of current liver failure with rise in transaminases of >25%
measure: Cytokine Storm
time frame: 28 days
description: Count of participants who develop cytokine storm as measured by elevated markers of inflammation (elevated D-dimer, hypofibrinogenemia, hyperferritinemia), evidence of acute respiratory distress syndrome (ARDS) measured by imaging findings and mechanical ventilator requirements, and/or continuous fever (≥ 38.1 ° Celsius unremitting)
measure: Respiratory Support
time frame: 28 days
description: Count of participants who require respiratory support in each of the following categories: nasal cannula, high flow nasal canula, non-rebreather mask, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or intubation. Patients may receive more than one type of support during their hospital stay.
measure: Vasopressor Medication Support
time frame: 28 days
description: Count of participants who received pressor drugs, as ordered by treating physicians
measure: Length of ICU Length of Stay
time frame: 28 days
description: Length of ICU stay in days, for participants who entered ICU
measure: Intensive Care Unit (ICU) Mortality
time frame: 28 days
description: Count of patients admitted to the ICU who die in ICU
measure: Hospital Length of Stay
time frame: 28 days
description: Length of hospital stay in days
measure: Ventilator Free Days
time frame: 28 days
description: Number of ventilator-free hospitalized days
measure: Intubation Duration
time frame: 28 days
description: Length of intubation, measured in days
measure: Readmission
time frame: 90 days
description: Count of participants readmitted to hospital following index procedure hospital discharge
measure: Serum Anti-SARS-CoV-2 IgG
time frame: During hospitalization, a maximum of 28 days
description: Count of participants positive for serum anti-SARS-CoV-2 IgG as assayed by the EUROIMMUN Anti-SARS-CoV-2 assay, evaluated semi-quantitatively by calculation of a ratio of the extinction of the patient sample over the extinction of a calibrator. This ratio is interpreted as: ratio < 0.8 is negative, ratio ≥ 0.8 to <1.0 is considered borderline, and ratio ≥ 1.1 is positive.
measure: SARS-CoV-2 RNA
time frame: During hospitalization, a maximum of 28 days
description: Count of participants with presence of SARS-CoV-2 RNA detected by reverse transcription polymerase chain reaction (RT-PCR) tested nasopharyngeal swabs.
measure: Mortality (Group A)
time frame: 28 days
description: Count of group A participants (non-intubated participants requiring >6 L supplemental oxygen to maintain oxygen saturation >92% at time of study entry and admitted <14 days) who die
measure: Time From Transfusion to End of Ventilator Support (Group B)
time frame: During hospitalization, a maximum of 28 days
description: Number of days from transfusion date until end of ventilator support for surviving group B participants (participants who are intubated at study entry)
arm group label: Group A
arm group type: Experimental
description: Hospitalized COVID-19 patients ages ≥18 years with respiratory symptoms, requiring >6 L of oxygen to maintain oxygen saturation >92%. Patient may not require intubation, and may be admitted for no longer than 14 days.
arm group label: Group B
arm group type: Experimental
description: Hospitalized COVID-19 patients ages ≥18 years requiring intubation.
intervention type: Biological
intervention name: COVID-19 convalescent plasma
description: Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
arm group label: Group A
arm group label: Group B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthew Sims, MD PhD
role: Principal Investigator
affiliation: Beaumont Health
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: William Beaumont Hospitals
investigator full name: Matthew Sims, MD, PhD
investigator title: Director Infectious Disease Research, Beaumont Health; Professor of Internal Medicine and Foundational Medical Studies, OUWB School of Medicine
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Severe Acute Respiratory Syndrome
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination due to changes in the Emergency Use Authorization for plasma during COVID-19. All plasma was labeled either low titer or high titer. The protocol required untitered plasma be used, which resulted in inability to complete the study and early termination.
point of contact: 