<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/NCT04463823</url>
  </required_header>
  <id_info>
    <org_study_id>148622</org_study_id>
    <nct_id>NCT04463823</nct_id>
  </id_info>
  <brief_title>&quot;NORPLASMA&quot; Covid-19 Convalescent Plasma Treatment Monitoring Study</brief_title>
  <acronym>MONITOR</acronym>
  <official_title>Covid-19 Convalescent Plasma Used for Treatment of Patients in Norway - a Monitoring Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sykehuset Telemark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sykehuset Ostfold</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Akershus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sorlandet Hospital HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helse Fonna HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      NORPLASMA COVID-19 includes both the production of convalescent plasma from approved blood&#xD;
      donors who have recovered from covid-19 (coronavirus disease 2019), and clinical studies to&#xD;
      evaluate efficacy and safety of the treatment, as recommended by European health authorities.&#xD;
      Patients who receive convalescent plasma in a clinical setting will be invited to participate&#xD;
      in the monitoring study NORPLASMA MONITOR, where clinical data about safety and effect on&#xD;
      clinical parameters including virus load and recovery time will be collected and compared to&#xD;
      european patients in a common database for the European countries. The treated patients can&#xD;
      be compared to a historical control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The NORPLASMA MONITOR study:&#xD;
&#xD;
      Main hypothesis: Plasma from selected COVID-19 convalescent blood donors contain&#xD;
      neutralizing/therapeutic antibodies against Severe acute respiratory syndrome coronavirus 2&#xD;
      (SARS-CoV-2) that may prevent generalized spreading of the infection if administered in a&#xD;
      sufficient dose at the right time.&#xD;
&#xD;
      The aim of the monitoring study is to monitor the treatment, characterize antibody&#xD;
      properties, dose requirements and safety issues.&#xD;
&#xD;
      In the NORPLASMA MONITOR study, the investigators will collect data from all patients treated&#xD;
      with convalescent plasma in Norwegian hospitals/care institutions. The data will be compared&#xD;
      to historical controls to evaluate efficacy, and for all transfusions, antibody&#xD;
      characteristics and effective doses can be retrospectively calculated.&#xD;
&#xD;
      The complete protocol is available on our web site&#xD;
      https://www.ous-research.no/home/norplasma.&#xD;
&#xD;
      Patients receiving COVID-19 convalescent plasma on a clinical indication as part of their&#xD;
      treatment should be included in the MONITOR study.&#xD;
&#xD;
      The purpose of the monitoring study is to collect as much clinical information as possible&#xD;
      about patients with COVID-19 before and after administration of convalescent plasma, together&#xD;
      with extensive data about blood donors and their antibody properties. Because the plasma&#xD;
      units cannot be fully standardized before use, it is of vital importance to record enough&#xD;
      data to allow necessary analysis and calculations, of e.g., antibody concentration in each&#xD;
      recipient. Data will also be shared within the European Union (EU) to obtain results in a&#xD;
      more efficient way from larger materials.&#xD;
&#xD;
      For the execution of this study, the project group intends to establish cooperation with all&#xD;
      hospitals/care institutions with transfusion procedures where COVID-19-patients are treated.&#xD;
      Contact will be established via local coordinators in the blood centers, and clinical&#xD;
      cooperation partners in relevant hospital departments will be recruited consecutively as&#xD;
      COVID-19 patients where plasma treatment is considered indicated, are admitted. Since the&#xD;
      treatment will be offered to these patients independent of study inclusion, it is important&#xD;
      to communicate the value of the patient inclusion and data collection to their responsible&#xD;
      care providers, so that participation can be encouraged.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 6, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>observation</measure>
    <time_frame>up to 2 years</time_frame>
    <description>clinical data and lab results from patients who receive COVID-19 convalescent plasma on a clinical indication, are being collected for later analysis</description>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>COVID</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are admitted to health institutions where transfusion therapy is routinely&#xD;
        given, and who are receiving COVID-19 convalescent plasma on a clinical indication as part&#xD;
        of their treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients treated with covid-19 convalescent plasma&#xD;
&#xD;
          -  patients who has provided informed consent or where nearest relative has given consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients included in other clinical studies of covid-19 treatment&#xD;
&#xD;
          -  consent not given&#xD;
&#xD;
        All eligible patients should be invited.&#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>Lise Sofie Haug Nissen-Meyer, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Helse Fonna</name>
      <address>
        <city>Haugesund</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sorlandet hospital</name>
      <address>
        <city>Kristiansand</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akershus University Hospital</name>
      <address>
        <city>Lørenskog</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sykehuset Ostfold</name>
      <address>
        <city>Sarpsborg</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sykehuset Telemark</name>
      <address>
        <city>Skien</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St.Olavs Hospital</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>August 30, 2022</last_update_submitted>
  <last_update_submitted_qc>August 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Lise Sofie Haug Nissen-Meyer</investigator_full_name>
    <investigator_title>Project manager</investigator_title>
  </responsible_party>
  <keyword>Convalescent plasma</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04463823
org study id: 148622
nct id: NCT04463823
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
NORPLASMA COVID-19 includes both the production of convalescent plasma from approved blood
      donors who have recovered from covid-19 (coronavirus disease 2019), and clinical studies to
      evaluate efficacy and safety of the treatment, as recommended by European health authorities.
      Patients who receive convalescent plasma in a clinical setting will be invited to participate
      in the monitoring study NORPLASMA MONITOR, where clinical data about safety and effect on
      clinical parameters including virus load and recovery time will be collected and compared to
      european patients in a common database for the European countries. The treated patients can
      be compared to a historical control group.
The NORPLASMA MONITOR study:

      Main hypothesis: Plasma from selected COVID-19 convalescent blood donors contain
      neutralizing/therapeutic antibodies against Severe acute respiratory syndrome coronavirus 2
      (SARS-CoV-2) that may prevent generalized spreading of the infection if administered in a
      sufficient dose at the right time.

      The aim of the monitoring study is to monitor the treatment, characterize antibody
      properties, dose requirements and safety issues.

      In the NORPLASMA MONITOR study, the investigators will collect data from all patients treated
      with convalescent plasma in Norwegian hospitals/care institutions. The data will be compared
      to historical controls to evaluate efficacy, and for all transfusions, antibody
      characteristics and effective doses can be retrospectively calculated.

      The complete protocol is available on our web site
      https://www.ous-research.no/home/norplasma.

      Patients receiving COVID-19 convalescent plasma on a clinical indication as part of their
      treatment should be included in the MONITOR study.

      The purpose of the monitoring study is to collect as much clinical information as possible
      about patients with COVID-19 before and after administration of convalescent plasma, together
      with extensive data about blood donors and their antibody properties. Because the plasma
      units cannot be fully standardized before use, it is of vital importance to record enough
      data to allow necessary analysis and calculations, of e.g., antibody concentration in each
      recipient. Data will also be shared within the European Union (EU) to obtain results in a
      more efficient way from larger materials.

      For the execution of this study, the project group intends to establish cooperation with all
      hospitals/care institutions with transfusion procedures where COVID-19-patients are treated.
      Contact will be established via local coordinators in the blood centers, and clinical
      cooperation partners in relevant hospital departments will be recruited consecutively as
      COVID-19 patients where plasma treatment is considered indicated, are admitted. Since the
      treatment will be offered to these patients independent of study inclusion, it is important
      to communicate the value of the patient inclusion and data collection to their responsible
      care providers, so that participation can be encouraged.
observational model: Case-Only
time perspective: Prospective
measure: observation
time frame: up to 2 years
description: clinical data and lab results from patients who receive COVID-19 convalescent plasma on a clinical indication, are being collected for later analysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lise Sofie Haug Nissen-Meyer, Ph.D.
role: Principal Investigator
affiliation: Oslo University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Lise Sofie Haug Nissen-Meyer
investigator title: Project manager