<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/NCT04432103</url>
  </required_header>
  <id_info>
    <org_study_id>ABC-20-14</org_study_id>
    <nct_id>NCT04432103</nct_id>
  </id_info>
  <brief_title>Treatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma</brief_title>
  <official_title>Treatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro Medico ABC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centro Medico ABC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Open label two arms, non randomized Convalescent Plasma treatment to severe and critical&#xD;
      pneumonia COVID-19 hospitlaized patients compared to a historical cohort with matched&#xD;
      controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will perform an open label two arms, non randomized trial giving Convalescent Plasma&#xD;
      donated from recovered COVID-19 patients with positive serology to severe and clinical&#xD;
      pneumonia COVID-19 patients admitted to the ABC Medical Center.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    There is new evidence that the Convalescent plasma is not useful for severe and critical&#xD;
    COVID-19 Pneumonia&#xD;
  </why_stopped>
  <start_date type="Actual">August 8, 2020</start_date>
  <completion_date type="Actual">January 29, 2021</completion_date>
  <primary_completion_date type="Actual">January 29, 2021</primary_completion_date>
  <phase>Phase 3</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>Two groups depending on the stage of the disease according to the CDC of China classification severe and critical COVID-19 pneumonia</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>INCIDENCE OF CRITICAL PNEUMONIA</measure>
    <time_frame>14 days after convalescent plasma administration</time_frame>
    <description>progression to critical stage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MORTALITY RATE AMONG CRITICAL PNEUMONIA PATIENTS</measure>
    <time_frame>28 days after convalescent plasma administration</time_frame>
    <description>mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>INCIDENCE OF MECHANICAL VENTILATION</measure>
    <time_frame>14 days after convalescent plasma treatment</time_frame>
    <description>time to need mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DAYS OF MECHANICAL VENTILATION</measure>
    <time_frame>28 days after convalescent plasma treatment</time_frame>
    <description>time of mechanical ventilation needed</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Covid-19</condition>
  <arm_group>
    <arm_group_label>Severe COVID-19 pneumonia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hospitalized patients with SARS-CoV 2 severe infection will receive an anti SARS-CoV 2 Convalescent Plasma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Critical COVID- 19 pneumonia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hospitalized patients with SARS-CoV 2 critical infection will receive an anti SARS-CoV 2 Convalescent Plasma</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patients</intervention_name>
    <description>Administration of Convalescent Plasma to COVID-19 obtained from donors with prior documented SARS-CoV 2 infection with IgG antibodies to hospitalized COVID-19 severe cases.</description>
    <arm_group_label>Severe COVID-19 pneumonia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patients</intervention_name>
    <description>Administration of Convalescent Plasma to COVID-19 obtained from donors with prior documented SARS-CoV 2 infection with IgG antibodies to hospitalized COVID-19 critical cases.</description>
    <arm_group_label>Critical COVID- 19 pneumonia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Donors:&#xD;
&#xD;
          1. Age: &gt;18 and &lt;60 years&#xD;
&#xD;
          2. Body weight : &gt;60 kg&#xD;
&#xD;
          3. Confirmed previous SARS CoV-2 infection&#xD;
&#xD;
          4. negative SARS CoV-2 test result&#xD;
&#xD;
          5. 21 day without symptoms from the negative SARS CoV2 negative test&#xD;
&#xD;
          6. Written informed consent to participate in this clinical trial, to donate plasma and&#xD;
             to store the specimen for future testing.&#xD;
&#xD;
          7. Positive COVID-19 IgG antibodies&#xD;
&#xD;
          8. Male donors, or female donors who have not been pregnant, or female donors who have&#xD;
             been pregnant tested negative for HLA antibodies&#xD;
&#xD;
          9. Individuals who meet all regular voluntary donor eligibility requirements by the&#xD;
             Mexican legislation.&#xD;
&#xD;
        Patients/recipients:&#xD;
&#xD;
          1. Age: &gt;18 years&#xD;
&#xD;
          2. Admitted to the ABC Medical Center facility for the treatment of COVID-19&#xD;
&#xD;
          3. Patients with severe or critical COVID-19&#xD;
&#xD;
          4. Informed consent provided by the patient or healthcare proxy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients/recipients:&#xD;
&#xD;
        1. Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood&#xD;
        products) 2. Any other not controlled infection 3. Disseminated Intravascular Coagulopathy&#xD;
        4. Patient under dialysis 5. Patient with recent Hemorrhagic Stroke 6. Severe Ischemic&#xD;
        Heart Disease&#xD;
&#xD;
        -&#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>Francisco Moreno, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ABC Medical Center Internal Medicine Department. Mexico City, Mexico</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Irma Hoyo, MD PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ABC Medical Center Internal Medicine Department. Mexico City, Mexico</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Benjamín Valente, MD MSc DTMH</last_name>
    <role>Principal Investigator</role>
    <affiliation>ABC Medical Center Internal Medicine Department. Mexico City, Mexico</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro Medico Abc</name>
      <address>
        <city>Mexico City</city>
        <zip>01120</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <link>
    <url>https://www-who-int.sire.ub.edu/dg/speeches/detail/who-director-general-s-remarks-at-the-media-briefing-on-2019-ncov-on-11-february-2020</url>
    <description>WHO Director-General's remarks at the media briefing on 2019-nCoV on 11 February 2020 [Internet]. [cited 2020 Mar 23].</description>
  </link>
  <link>
    <url>http://coronavirus.jhu.edu/</url>
    <description>Johns Hopkins Coronavirus Resource Center [Internet]. Johns Hopkins Coronavirus Resource Center. [cited 2020 Mar 23].</description>
  </link>
  <link>
    <url>http://www.ecdc.europa.eu/en/geographical-distribution-2019-ncov-cases</url>
    <description>Situation update worldwide, as of 22 March 2020 [Internet]. European Centre for Disease Prevention and Control. [cited 2020 Mar 23]</description>
  </link>
  <link>
    <url>http://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports</url>
    <description>Novel Coronavirus (2019-nCoV) situation reports [Internet]. [cited 2020 Mar 23].</description>
  </link>
  <link>
    <url>http://www-who-int.sire.ub.edu/docs/default-source/coronaviruse/who-china-joint-mission-on-covid-19-final-report.pdf</url>
    <description>who-china-joint-mission-on-covid-19-final-report.pdf [Internet]. [cited 2020 Mar 23].</description>
  </link>
  <link>
    <url>http://www-cdc-gov.sire.ub.edu/coronavirus/2019-ncov/hcp/clinical-criteria.html</url>
    <description>CDC. Coronavirus Disease 2019 (COVID-19) [Internet]. Centers for Disease Control and Prevention. 2020 [cited 2020 Apr 7].</description>
  </link>
  <link>
    <url>https://ccpp19.org/</url>
    <description>National COVID-19 Convalescent Plasma Project [Internet]. [cited 2020 Apr 8].</description>
  </link>
  <link>
    <url>https://www.uscovidplasma.org/</url>
    <description>Convalescent Plasma COVID-19 (Coronavirus) Treatment - Mayo Clinic [Internet]. [cited 2020 Apr 8]. Available from:</description>
  </link>
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    <citation>Zhang B, Liu S, Tan T, Huang W, Dong Y, Chen L, Chen Q, Zhang L, Zhong Q, Zhang X, Zou Y, Zhang S. Treatment With Convalescent Plasma for Critically Ill Patients With Severe Acute Respiratory Syndrome Coronavirus 2 Infection. Chest. 2020 Jul;158(1):e9-e13. doi: 10.1016/j.chest.2020.03.039. Epub 2020 Mar 31.</citation>
    <PMID>32243945</PMID>
  </results_reference>
  <results_reference>
    <citation>Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6.</citation>
    <PMID>32253318</PMID>
  </results_reference>
  <results_reference>
    <citation>Bloch EM, Shoham S, Casadevall A, Sachais BS, Shaz B, Winters JL, van Buskirk C, Grossman BJ, Joyner M, Henderson JP, Pekosz A, Lau B, Wesolowski A, Katz L, Shan H, Auwaerter PG, Thomas D, Sullivan DJ, Paneth N, Gehrie E, Spitalnik S, Hod EA, Pollack L, Nicholson WT, Pirofski LA, Bailey JA, Tobian AA. Deployment of convalescent plasma for the prevention and treatment of COVID-19. J Clin Invest. 2020 Jun 1;130(6):2757-2765. doi: 10.1172/JCI138745.</citation>
    <PMID>32254064</PMID>
  </results_reference>
  <results_reference>
    <citation>O'Shaughnessy DF, Atterbury C, Bolton Maggs P, Murphy M, Thomas D, Yates S, Williamson LM; British Committee for Standards in Haematology, Blood Transfusion Task Force. Guidelines for the use of fresh-frozen plasma, cryoprecipitate and cryosupernatant. Br J Haematol. 2004 Jul;126(1):11-28. doi: 10.1111/j.1365-2141.2004.04972.x.</citation>
    <PMID>15198728</PMID>
  </results_reference>
  <verification_date>July 2021</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>
  <last_update_submitted>July 30, 2021</last_update_submitted>
  <last_update_submitted_qc>July 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>covid-19</keyword>
  <keyword>pneumonia</keyword>
  <keyword>pandemic</keyword>
  <keyword>convalescent plasma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04432103
org study id: ABC-20-14
nct id: NCT04432103
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Open label two arms, non randomized Convalescent Plasma treatment to severe and critical
      pneumonia COVID-19 hospitlaized patients compared to a historical cohort with matched
      controls.
We will perform an open label two arms, non randomized trial giving Convalescent Plasma
      donated from recovered COVID-19 patients with positive serology to severe and clinical
      pneumonia COVID-19 patients admitted to the ABC Medical Center.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Two groups depending on the stage of the disease according to the CDC of China classification severe and critical COVID-19 pneumonia
primary purpose: Treatment
masking: None (Open Label)
measure: INCIDENCE OF CRITICAL PNEUMONIA
time frame: 14 days after convalescent plasma administration
description: progression to critical stage
measure: MORTALITY RATE AMONG CRITICAL PNEUMONIA PATIENTS
time frame: 28 days after convalescent plasma administration
description: mortality
measure: INCIDENCE OF MECHANICAL VENTILATION
time frame: 14 days after convalescent plasma treatment
description: time to need mechanical ventilation
measure: DAYS OF MECHANICAL VENTILATION
time frame: 28 days after convalescent plasma treatment
description: time of mechanical ventilation needed
arm group label: Severe COVID-19 pneumonia
arm group type: Experimental
description: Hospitalized patients with SARS-CoV 2 severe infection will receive an anti SARS-CoV 2 Convalescent Plasma
arm group label: Critical COVID- 19 pneumonia
arm group type: Experimental
description: Hospitalized patients with SARS-CoV 2 critical infection will receive an anti SARS-CoV 2 Convalescent Plasma
intervention type: Biological
intervention name: Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patients
description: Administration of Convalescent Plasma to COVID-19 obtained from donors with prior documented SARS-CoV 2 infection with IgG antibodies to hospitalized COVID-19 severe cases.
arm group label: Severe COVID-19 pneumonia
intervention type: Biological
intervention name: Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patients
description: Administration of Convalescent Plasma to COVID-19 obtained from donors with prior documented SARS-CoV 2 infection with IgG antibodies to hospitalized COVID-19 critical cases.
arm group label: Critical COVID- 19 pneumonia
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Francisco Moreno, MD
role: Principal Investigator
affiliation: ABC Medical Center Internal Medicine Department. Mexico City, Mexico
last name: Irma Hoyo, MD PHD
role: Principal Investigator
affiliation: ABC Medical Center Internal Medicine Department. Mexico City, Mexico
last name: Benjamín Valente, MD MSc DTMH
role: Principal Investigator
affiliation: ABC Medical Center Internal Medicine Department. Mexico City, Mexico
facility: 
country: Mexico
url: https://www-who-int.sire.ub.edu/dg/speeches/detail/who-director-general-s-remarks-at-the-media-briefing-on-2019-ncov-on-11-february-2020
description: WHO Director-General's remarks at the media briefing on 2019-nCoV on 11 February 2020 [Internet]. [cited 2020 Mar 23].
url: http://coronavirus.jhu.edu/
description: Johns Hopkins Coronavirus Resource Center [Internet]. Johns Hopkins Coronavirus Resource Center. [cited 2020 Mar 23].
url: http://www.ecdc.europa.eu/en/geographical-distribution-2019-ncov-cases
description: Situation update worldwide, as of 22 March 2020 [Internet]. European Centre for Disease Prevention and Control. [cited 2020 Mar 23]
url: http://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports
description: Novel Coronavirus (2019-nCoV) situation reports [Internet]. [cited 2020 Mar 23].
url: http://www-who-int.sire.ub.edu/docs/default-source/coronaviruse/who-china-joint-mission-on-covid-19-final-report.pdf
description: who-china-joint-mission-on-covid-19-final-report.pdf [Internet]. [cited 2020 Mar 23].
url: http://www-cdc-gov.sire.ub.edu/coronavirus/2019-ncov/hcp/clinical-criteria.html
description: CDC. Coronavirus Disease 2019 (COVID-19) [Internet]. Centers for Disease Control and Prevention. 2020 [cited 2020 Apr 7].
url: https://ccpp19.org/
description: National COVID-19 Convalescent Plasma Project [Internet]. [cited 2020 Apr 8].
url: https://www.uscovidplasma.org/
description: Convalescent Plasma COVID-19 (Coronavirus) Treatment - Mayo Clinic [Internet]. [cited 2020 Apr 8]. Available from:
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PMID: 32243945
citation: Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6.
PMID: 32253318
citation: Bloch EM, Shoham S, Casadevall A, Sachais BS, Shaz B, Winters JL, van Buskirk C, Grossman BJ, Joyner M, Henderson JP, Pekosz A, Lau B, Wesolowski A, Katz L, Shan H, Auwaerter PG, Thomas D, Sullivan DJ, Paneth N, Gehrie E, Spitalnik S, Hod EA, Pollack L, Nicholson WT, Pirofski LA, Bailey JA, Tobian AA. Deployment of convalescent plasma for the prevention and treatment of COVID-19. J Clin Invest. 2020 Jun 1;130(6):2757-2765. doi: 10.1172/JCI138745.
PMID: 32254064
citation: O'Shaughnessy DF, Atterbury C, Bolton Maggs P, Murphy M, Thomas D, Yates S, Williamson LM; British Committee for Standards in Haematology, Blood Transfusion Task Force. Guidelines for the use of fresh-frozen plasma, cryoprecipitate and cryosupernatant. Br J Haematol. 2004 Jul;126(1):11-28. doi: 10.1111/j.1365-2141.2004.04972.x.
PMID: 15198728
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia
sharing ipd: No