<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/NCT04407208</url>
  </required_header>
  <id_info>
    <org_study_id>3471041S322342020040800002</org_study_id>
    <nct_id>NCT04407208</nct_id>
  </id_info>
  <brief_title>Convalescent Plasma Therapy in Patients With COVID-19</brief_title>
  <official_title>Convalescent Plasma Therapy in Patients With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biofarma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rumah Sakit Pusat Angkatan Darat Gatot Soebroto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eijkman Institute for Molecular Biology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Biofarma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Scientists and medical workers all around the world were running out of time to manage&#xD;
      COVID-19. Several studies have been done to understand the disease and ultimately to find&#xD;
      possible treatment. Based on those studies, one of the potential treatment was antibody&#xD;
      transfer from recovered COVID-19 patients. Passive antibody transfer was a fast and easy&#xD;
      choice. The rational use of antibody from the patient's plasma is a natural neutralizing&#xD;
      protein to the cell-infected virus and could possibly slow the active infection down.&#xD;
      Investigators initiate an intervention study with purposes to produce quality convalescent&#xD;
      plasma from the recovered patients, define the safety of plasma for human use and as an&#xD;
      alternative treatment to improve the clinical outcomes of severe COVID-19 patients.&#xD;
&#xD;
      The study hypothesis is convalescent plasma is safe and could possibly improve outcome of&#xD;
      severe (non-critical) COVID-19 patients. This research will conduct the plaque reduction&#xD;
      neutralizing test (PRNT) of recipient blood in vitro. The plasma will be collected in the&#xD;
      blood transfusion unit (BTU) in Gatot Soebroto hospital. The storage, testing, transfer, and&#xD;
      transfusion of eligible convalescent plasma are the authority of Gatot Soebroto BTU. PRNT and&#xD;
      plasma antibody titer measurement from donor plasma will be conducted at Eijkman Institute of&#xD;
      Molecular Biology.&#xD;
&#xD;
      Investigators enroll approximately 10 patients consecutively, who will be admitted at Gatot&#xD;
      Soebroto hospital. Baseline demographic characteristics of samples are recorded. Clinical dan&#xD;
      laboratory data will be measured before and after plasma transfusion periodically. The&#xD;
      measured variables are pharmacological therapy (antivirus, antibiotics, steroids), invasive&#xD;
      oxygen therapy, oxygen index, sequential organ failure assessment (SOFA) score, and&#xD;
      laboratory parameters such as leukocyte count, blood chemical panel include liver and renal&#xD;
      function, C-reactive protein, procalcitonin, IL-6 and immunoglobulin titer of the recipient&#xD;
      and also chest X-ray evaluation.&#xD;
&#xD;
      The potential expected risk of plasma transfusions is transfusion reaction (immunological or&#xD;
      non-immune related) and transferred foreign pathogen. Investigator will report and treat all&#xD;
      adverse events after plasma transfusion has been done. A severe adverse event (SAE) will also&#xD;
      report in a special form to sponsor and data safety monitoring board (DSMB). There is&#xD;
      theoretically antibody-dependent enhancement (ADE) mechanism from COVID-19 whom will receive&#xD;
      plasma transfusion to progress to severe immune response.&#xD;
&#xD;
      This preliminary study is supposed to provide supporting data and experience of plasma&#xD;
      processing to a larger study in the near future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The rational use of antibodies from the recovered patient's plasma as a natural neutralizing&#xD;
      antibody to the cell-infected virus (plaques). Several expanded use of convalescent plasma&#xD;
      therapy to severe and/or critically ill COVID-19 patients had been done in the US and China.&#xD;
      Investigator reported that 5 patients received convalescent plasma, three patients were&#xD;
      successfully discharged and 2 patients improved.&#xD;
&#xD;
      Based on the previous study, investigators initiate an intervention study with purposes to&#xD;
      produce quality convalescent plasma from the recovered patients and to find an alternative&#xD;
      treatment to improve the clinical outcomes of severe COVID-19 patients.&#xD;
&#xD;
      Investigators research questions are&#xD;
&#xD;
        1. Are the convalescent plasma could neutralize cell-infected virus in vitro?&#xD;
&#xD;
        2. Are those COVID-19 patients who received convalescent plasma will have a better&#xD;
           prognosis and possibly be cured? The Investigator study hypothesis is convalescent&#xD;
           plasma could possibly cure severe (non-critical) COVID-19 patients.&#xD;
&#xD;
      The primary objective of this study is to produce a good quality convalescent plasma from&#xD;
      recovered COVID-19 patient which could neutralize the plaque in vitro and in Vivo. In Vivo&#xD;
      neutralization will be monitored based on the patient's clinical improvement of symptoms,&#xD;
      laboratory, and radiology assessment.&#xD;
&#xD;
      Invitro tests will be done to the recipient plasma before and after convalescent plasma&#xD;
      transfusion. The objective evaluation will be a plaque reduction neutralizing test (PRNT) of&#xD;
      recipient plasma. Donor plasma will be collected by apheresis methods at the Gatot Soebroto&#xD;
      Blood transfusion unit (BTU).&#xD;
&#xD;
      All donors must meet the eligibility criteria and sign an informed consent form. Donor's&#xD;
      plasma will be screened for blood-borne infection pathogens in BTU. Each donor will produce&#xD;
      210 ml of plasma, which 200 ml will be stored in 2 separate bags (each 100 ml) and 3 ml of&#xD;
      plasma will be tested for antibody anti-COVID-19 titer in Biofarma and 3 ml of plasma will be&#xD;
      tested for PRNT in Eijkman Institute. Plasma transfusion will be given to COVID-19 patients&#xD;
      with severe (IIb) and critical conditions. The storage, testing, transfer, and transfusion of&#xD;
      eligible convalescent plasma are the authority of Gatot Soebroto BTU. Investigators enroll&#xD;
      approximately 10 patients consecutively, who will be admitted at Gatot Soebroto hospital.&#xD;
&#xD;
      All recipients will be enrolled consecutively if they met the eligibility criteria. Baseline&#xD;
      demographic characteristics of the included patient are recorded in case report forms.&#xD;
      Clinical and laboratory data will be measured before the plasma transfusion. Pre-transfusion&#xD;
      patients will be put in group 1. Whereas group 2 is the same patient but received the&#xD;
      convalescent plasma.&#xD;
&#xD;
      Transfusions will be given twice in 100 ml bag, during the 1st 4 hours, the acute adverse&#xD;
      event will be monitored. There will be three serial transfusions, on the 1st day, 3rd day,&#xD;
      and 6th day. The clinical, laboratory and radiology parameters will be re-measured after&#xD;
      the14th day and they will be analyzed.&#xD;
&#xD;
      Data analysis will be done after all the measurement is finished and recorded in clinical&#xD;
      report form. Investigators will find the mean difference of ordinal variables between group 1&#xD;
      and group two with the Wilcoxon signed-rank test (alternative to the paired T-test). The&#xD;
      relative risk (risk reduction) of nominal variables will be measured between group 1 and&#xD;
      group 2. Unfortunately, it is impossible to determine the number needed to harm (NNH) in this&#xD;
      research since both groups are depending on each other.&#xD;
&#xD;
      All documents regarding the study will be kept in data form and will be protected with a&#xD;
      password. We will concern about the safety of convalescent plasma by recording all adverse&#xD;
      events after transfusion. To anticipate the risk of AE progression to a severe adverse event&#xD;
      (SAE), all of the AE will be treated as soon as it is found according to the clinical&#xD;
      competence of treating physicians. SAE will be reported in a certain form to sponsor and data&#xD;
      safety monitoring board as soon as possible.&#xD;
&#xD;
      Investigators are all aware of the potential ethical issue regarding this study. The plasma&#xD;
      convalescent is an alternative therapy for COVID-19, and urgently needed because of the&#xD;
      pandemic situation currently happen. Investigators are weighing all potential expected and&#xD;
      theoretical risks and benefits of convalescent plasma transfusion. The potential expected&#xD;
      risk of plasma transfusions is transfusion reaction (immunological or non-immune related) and&#xD;
      transferred unwanted pathogen. The theoretical risk from plasma transfusion of COVID-19&#xD;
      patient is an antibody-dependent enhancement (ADE) mechanism as seen in dengue patients. A&#xD;
      Potential benefit of plasma for the patient is the neutralizing potential of a polyclonal&#xD;
      antibody to cell infected SARS-Cov2. Resulting in faster recovery and improvement of the&#xD;
      disease stages.&#xD;
&#xD;
      All donors will read the informed consent form thoroughly and willingly given their plasma&#xD;
      draw at Gatot Soebroto BTU. The donor could revoke his/her consent at any time before being&#xD;
      transfused, even after the plasma has been processed and stored in BTU. Donor's decision will&#xD;
      not affect his/her future treatment at Gatot Soebroto hospital.&#xD;
&#xD;
      This preliminary study is supposed to provide supporting data and experience of plasma&#xD;
      processing to a larger study in the near future.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">June 22, 2020</completion_date>
  <primary_completion_date type="Actual">June 22, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>single-arm, pre, and post-test dependent group</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plaque reduction neutralization test (PNRT)</measure>
    <time_frame>day 7 after first transfusion</time_frame>
    <description>PNRT50</description>
  </primary_outcome>
  <primary_outcome>
    <measure>D-dimer</measure>
    <time_frame>day 1,4,7,14 after first transfusion</time_frame>
    <description>Change of D-dimer compared between pre and post transfusion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>C-Reactive Protein (CRP)</measure>
    <time_frame>day 1,4,7,14 after first transfusion</time_frame>
    <description>Change of CRP compared between pre and post transfusion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>International Normalized Ratio (INR)</measure>
    <time_frame>day 1,4,7,14 after first transfusion</time_frame>
    <description>Change of INR compared between pre and post transfusion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxygenation Index</measure>
    <time_frame>day 1,4,7,14 after first transfusion</time_frame>
    <description>Change of OI compared between pre and post transfusion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chest X-ray</measure>
    <time_frame>day 1,4,7,28 after first transfusion</time_frame>
    <description>Change of CXR with CXR covid score compared between pre and post transfusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>severe adverse event</measure>
    <time_frame>from day 0 to 14 days after plasma transfusion</time_frame>
    <description>every adverse event that cause patient to die, prolonged hospitalization or worsening clinical stage of illness</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Convalescence</condition>
  <condition>Corona Virus Infection</condition>
  <condition>Plaque</condition>
  <arm_group>
    <arm_group_label>Convalescent plasma recipient</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Recipients receive 3 times of each 100 ml convalescent plasma on day 0, 3, and 6</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Convalescent plasma</intervention_name>
    <description>The minimum titer of specific antibody is 1/80</description>
    <arm_group_label>Convalescent plasma recipient</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed COVID-19 case with RT-PCR&#xD;
&#xD;
          -  Stage IIb of COVID-19 or higher&#xD;
&#xD;
          -  Consent was given by the patient or legal guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  History of anaphylactic reaction in previous blood product transfusion&#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>Nana Sarnadi, Sp.OG</last_name>
    <role>Study Director</role>
    <affiliation>director of research and develpment</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gatot Soebroto central army presidential hospital</name>
      <address>
        <city>Jakarta Pusat</city>
        <zip>10410</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <link>
    <url>https://jamanetwork.com/journals/jama/fullarticle/2762130</url>
    <description>Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China</description>
  </link>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 16, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>June 27, 2020</last_update_submitted>
  <last_update_submitted_qc>June 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Biofarma</investigator_affiliation>
    <investigator_full_name>dr. Marliana Sri Rejeki, Sp.FK</investigator_full_name>
    <investigator_title>Medical doctor, clinical pharmacologist</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>convalescent plasma</keyword>
  <keyword>treatment</keyword>
  <keyword>severe ill</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>Convalescence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/08/NCT04407208/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04407208
org study id: 3471041S322342020040800002
nct id: NCT04407208
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Scientists and medical workers all around the world were running out of time to manage
      COVID-19. Several studies have been done to understand the disease and ultimately to find
      possible treatment. Based on those studies, one of the potential treatment was antibody
      transfer from recovered COVID-19 patients. Passive antibody transfer was a fast and easy
      choice. The rational use of antibody from the patient's plasma is a natural neutralizing
      protein to the cell-infected virus and could possibly slow the active infection down.
      Investigators initiate an intervention study with purposes to produce quality convalescent
      plasma from the recovered patients, define the safety of plasma for human use and as an
      alternative treatment to improve the clinical outcomes of severe COVID-19 patients.

      The study hypothesis is convalescent plasma is safe and could possibly improve outcome of
      severe (non-critical) COVID-19 patients. This research will conduct the plaque reduction
      neutralizing test (PRNT) of recipient blood in vitro. The plasma will be collected in the
      blood transfusion unit (BTU) in Gatot Soebroto hospital. The storage, testing, transfer, and
      transfusion of eligible convalescent plasma are the authority of Gatot Soebroto BTU. PRNT and
      plasma antibody titer measurement from donor plasma will be conducted at Eijkman Institute of
      Molecular Biology.

      Investigators enroll approximately 10 patients consecutively, who will be admitted at Gatot
      Soebroto hospital. Baseline demographic characteristics of samples are recorded. Clinical dan
      laboratory data will be measured before and after plasma transfusion periodically. The
      measured variables are pharmacological therapy (antivirus, antibiotics, steroids), invasive
      oxygen therapy, oxygen index, sequential organ failure assessment (SOFA) score, and
      laboratory parameters such as leukocyte count, blood chemical panel include liver and renal
      function, C-reactive protein, procalcitonin, IL-6 and immunoglobulin titer of the recipient
      and also chest X-ray evaluation.

      The potential expected risk of plasma transfusions is transfusion reaction (immunological or
      non-immune related) and transferred foreign pathogen. Investigator will report and treat all
      adverse events after plasma transfusion has been done. A severe adverse event (SAE) will also
      report in a special form to sponsor and data safety monitoring board (DSMB). There is
      theoretically antibody-dependent enhancement (ADE) mechanism from COVID-19 whom will receive
      plasma transfusion to progress to severe immune response.

      This preliminary study is supposed to provide supporting data and experience of plasma
      processing to a larger study in the near future.
The rational use of antibodies from the recovered patient's plasma as a natural neutralizing
      antibody to the cell-infected virus (plaques). Several expanded use of convalescent plasma
      therapy to severe and/or critically ill COVID-19 patients had been done in the US and China.
      Investigator reported that 5 patients received convalescent plasma, three patients were
      successfully discharged and 2 patients improved.

      Based on the previous study, investigators initiate an intervention study with purposes to
      produce quality convalescent plasma from the recovered patients and to find an alternative
      treatment to improve the clinical outcomes of severe COVID-19 patients.

      Investigators research questions are

        1. Are the convalescent plasma could neutralize cell-infected virus in vitro?

        2. Are those COVID-19 patients who received convalescent plasma will have a better
           prognosis and possibly be cured? The Investigator study hypothesis is convalescent
           plasma could possibly cure severe (non-critical) COVID-19 patients.

      The primary objective of this study is to produce a good quality convalescent plasma from
      recovered COVID-19 patient which could neutralize the plaque in vitro and in Vivo. In Vivo
      neutralization will be monitored based on the patient's clinical improvement of symptoms,
      laboratory, and radiology assessment.

      Invitro tests will be done to the recipient plasma before and after convalescent plasma
      transfusion. The objective evaluation will be a plaque reduction neutralizing test (PRNT) of
      recipient plasma. Donor plasma will be collected by apheresis methods at the Gatot Soebroto
      Blood transfusion unit (BTU).

      All donors must meet the eligibility criteria and sign an informed consent form. Donor's
      plasma will be screened for blood-borne infection pathogens in BTU. Each donor will produce
      210 ml of plasma, which 200 ml will be stored in 2 separate bags (each 100 ml) and 3 ml of
      plasma will be tested for antibody anti-COVID-19 titer in Biofarma and 3 ml of plasma will be
      tested for PRNT in Eijkman Institute. Plasma transfusion will be given to COVID-19 patients
      with severe (IIb) and critical conditions. The storage, testing, transfer, and transfusion of
      eligible convalescent plasma are the authority of Gatot Soebroto BTU. Investigators enroll
      approximately 10 patients consecutively, who will be admitted at Gatot Soebroto hospital.

      All recipients will be enrolled consecutively if they met the eligibility criteria. Baseline
      demographic characteristics of the included patient are recorded in case report forms.
      Clinical and laboratory data will be measured before the plasma transfusion. Pre-transfusion
      patients will be put in group 1. Whereas group 2 is the same patient but received the
      convalescent plasma.

      Transfusions will be given twice in 100 ml bag, during the 1st 4 hours, the acute adverse
      event will be monitored. There will be three serial transfusions, on the 1st day, 3rd day,
      and 6th day. The clinical, laboratory and radiology parameters will be re-measured after
      the14th day and they will be analyzed.

      Data analysis will be done after all the measurement is finished and recorded in clinical
      report form. Investigators will find the mean difference of ordinal variables between group 1
      and group two with the Wilcoxon signed-rank test (alternative to the paired T-test). The
      relative risk (risk reduction) of nominal variables will be measured between group 1 and
      group 2. Unfortunately, it is impossible to determine the number needed to harm (NNH) in this
      research since both groups are depending on each other.

      All documents regarding the study will be kept in data form and will be protected with a
      password. We will concern about the safety of convalescent plasma by recording all adverse
      events after transfusion. To anticipate the risk of AE progression to a severe adverse event
      (SAE), all of the AE will be treated as soon as it is found according to the clinical
      competence of treating physicians. SAE will be reported in a certain form to sponsor and data
      safety monitoring board as soon as possible.

      Investigators are all aware of the potential ethical issue regarding this study. The plasma
      convalescent is an alternative therapy for COVID-19, and urgently needed because of the
      pandemic situation currently happen. Investigators are weighing all potential expected and
      theoretical risks and benefits of convalescent plasma transfusion. The potential expected
      risk of plasma transfusions is transfusion reaction (immunological or non-immune related) and
      transferred unwanted pathogen. The theoretical risk from plasma transfusion of COVID-19
      patient is an antibody-dependent enhancement (ADE) mechanism as seen in dengue patients. A
      Potential benefit of plasma for the patient is the neutralizing potential of a polyclonal
      antibody to cell infected SARS-Cov2. Resulting in faster recovery and improvement of the
      disease stages.

      All donors will read the informed consent form thoroughly and willingly given their plasma
      draw at Gatot Soebroto BTU. The donor could revoke his/her consent at any time before being
      transfused, even after the plasma has been processed and stored in BTU. Donor's decision will
      not affect his/her future treatment at Gatot Soebroto hospital.

      This preliminary study is supposed to provide supporting data and experience of plasma
      processing to a larger study in the near future.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: single-arm, pre, and post-test dependent group
primary purpose: Health Services Research
masking: None (Open Label)
measure: Plaque reduction neutralization test (PNRT)
time frame: day 7 after first transfusion
description: PNRT50
measure: D-dimer
time frame: day 1,4,7,14 after first transfusion
description: Change of D-dimer compared between pre and post transfusion
measure: C-Reactive Protein (CRP)
time frame: day 1,4,7,14 after first transfusion
description: Change of CRP compared between pre and post transfusion
measure: International Normalized Ratio (INR)
time frame: day 1,4,7,14 after first transfusion
description: Change of INR compared between pre and post transfusion
measure: Oxygenation Index
time frame: day 1,4,7,14 after first transfusion
description: Change of OI compared between pre and post transfusion
measure: Chest X-ray
time frame: day 1,4,7,28 after first transfusion
description: Change of CXR with CXR covid score compared between pre and post transfusion
measure: severe adverse event
time frame: from day 0 to 14 days after plasma transfusion
description: every adverse event that cause patient to die, prolonged hospitalization or worsening clinical stage of illness
arm group label: Convalescent plasma recipient
arm group type: Experimental
description: Recipients receive 3 times of each 100 ml convalescent plasma on day 0, 3, and 6
intervention type: Biological
intervention name: Convalescent plasma
description: The minimum titer of specific antibody is 1/80
arm group label: Convalescent plasma recipient
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nana Sarnadi, Sp.OG
role: Study Director
affiliation: director of research and develpment
facility: 
country: Indonesia
url: https://jamanetwork.com/journals/jama/fullarticle/2762130
description: Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China
responsible party type: Principal Investigator
investigator affiliation: Biofarma
investigator full name: dr. Marliana Sri Rejeki, Sp.FK
investigator title: Medical doctor, clinical pharmacologist
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Convalescence
sharing ipd: No
provided document: 