<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/NCT04468009</url>
  </required_header>
  <id_info>
    <org_study_id>1725</org_study_id>
    <nct_id>NCT04468009</nct_id>
  </id_info>
  <brief_title>Treatment of Critically Ill Patients With Covid-19 With Convalescent Plasma</brief_title>
  <official_title>Treatment of Critically Ill Patients With Covid-19 With Convalescent Plasma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Infecciosas Francisco Javier Muniz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Infecciosas Francisco Javier Muniz</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>
      This study aims to collect convalescent plasma and use it as experimental treatment in&#xD;
      critically ill Covid-19 patients in order to reduce mortality and length of stay in intensive&#xD;
      care unit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to use convalescent plasma as experimental treatment in critically ill&#xD;
      Covid-19 patients in order to reduce mortality and length of stay in intensive care unit.&#xD;
      Donors must have anti-SARS CoV2 antibodies. Recipients must be critically ill Covid-19&#xD;
      patients on mechanical ventilation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Actual">June 19, 2021</completion_date>
  <primary_completion_date type="Actual">January 19, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality at ICU at 30 days</measure>
    <time_frame>Mortality at 30 days</time_frame>
    <description>Mortality at 30 days of Intensive Care Unit (ICU) admission</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality at ICU at 90 days</measure>
    <time_frame>Mortality at 90 days</time_frame>
    <description>Mortality at 90 days of ICU admission</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SOFA score of study days 1, 3, 5, 7, 14 and 28</measure>
    <time_frame>Study days 1, 3, 5, 7, 14 and 28</time_frame>
    <description>Sequential Organ Failure Assessment (SOFA) of study days 1, 3, 5, 7, 14 and 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for supportive therapy after enrollment</measure>
    <time_frame>Duration of supportive therapy through study completion, an average of 3 months</time_frame>
    <description>Duration (number of days) of supportive therapy (oxygen and ventilation, dialysis, vasopressors) after enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lenght of stay in ICU</measure>
    <time_frame>Duration of stay in ICU through study completion, an average of 3 months</time_frame>
    <description>Duration (number of days) of stay in ICU between ICU admission and ICU final discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lenght of mechanical ventilation</measure>
    <time_frame>Duration of mechanical ventilation through study completion, an average of 3 months</time_frame>
    <description>Duration (number of days) of mechanical ventilation between beginning and final liberation from mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lenght of hospitalization</measure>
    <time_frame>Duration of hospitalization through study completion, an average of 3 months</time_frame>
    <description>Duration (number of days) of hospitalization between hospital admission and final hospital discharge</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Lenght of hospitalization after ICU discharge</measure>
    <time_frame>Duration (number of days) of hospitalization through study completion, an average of 3 months</time_frame>
    <description>Duration (number of days) of hospitalization after ICU discharge</description>
  </other_outcome>
  <other_outcome>
    <measure>Days without ventilation after enrollment</measure>
    <time_frame>Days without ventilation through study completion, an average of 3 months</time_frame>
    <description>Number of days without ventilation after enrollment</description>
  </other_outcome>
  <other_outcome>
    <measure>Days without vasopressors after enrollment</measure>
    <time_frame>Days without vasopressors through study completion, an average of 3 months</time_frame>
    <description>Number of days without vasopressors after enrollment</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in Chest X-ray</measure>
    <time_frame>Changes in Chest X-ray through study completion, an average of 3 months</time_frame>
    <description>Changes in Chest X-ray (unilateral, bilateral, unique, multiple, pleural effusion) after enrollment</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">134</enrollment>
  <condition>SARS-Associated Coronavirus</condition>
  <condition>Covid19</condition>
  <condition>SARS-CoV Infection</condition>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care for Covid-19</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PCC-19</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with convalescent plasma</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Convalescent plasma</intervention_name>
    <description>Convalescent plasma from patients recovering from Covid-19 and which had anti-SARS-Cov-2 antibodies</description>
    <arm_group_label>PCC-19</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 years or more.&#xD;
&#xD;
          -  Patient with Covid-19 confirmed with nuclear acid testing&#xD;
&#xD;
          -  Critically ill patients with Covid-19 on mechanical ventilation. Potencially&#xD;
             critically ill patients (with acute respiratory distress syndrome, septic shock and/or&#xD;
             multiple organ failure) with Covid-19.&#xD;
&#xD;
          -  Diagnosed with acute respiratory distress syndrome.&#xD;
&#xD;
          -  Informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No consent.&#xD;
&#xD;
          -  Symptoms for a period longer than 20 days.&#xD;
&#xD;
          -  Not detectable by acid nuclear testing within 48 hours prior to elegibility.&#xD;
&#xD;
          -  Descompensated congestive heart failure, in which receiving 500ml of intrasvascular&#xD;
             volume signifies a life risk.&#xD;
&#xD;
          -  History of severe adverse events or anaphylaxis to plasma components&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlos A Gonzalez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Infecciosas Francisco Javier Muniz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Francisco Javier Muñiz</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aire</city>
        <zip>1663</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <reference>
    <citation>Enria DA, Briggiler AM, Fernandez NJ, Levis SC, Maiztegui JI. Importance of dose of neutralising antibodies in treatment of Argentine haemorrhagic fever with immune plasma. Lancet. 1984 Aug 4;2(8397):255-6. doi: 10.1016/s0140-6736(84)90299-x.</citation>
    <PMID>6146809</PMID>
  </reference>
  <reference>
    <citation>Rojas M, Rodriguez Y, Monsalve DM, Acosta-Ampudia Y, Camacho B, Gallo JE, Rojas-Villarraga A, Ramirez-Santana C, Diaz-Coronado JC, Manrique R, Mantilla RD, Shoenfeld Y, Anaya JM. Convalescent plasma in Covid-19: Possible mechanisms of action. Autoimmun Rev. 2020 Jul;19(7):102554. doi: 10.1016/j.autrev.2020.102554. Epub 2020 May 5.</citation>
    <PMID>32380316</PMID>
  </reference>
  <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>
  </reference>
  <reference>
    <citation>Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.</citation>
    <PMID>32219428</PMID>
  </reference>
  <reference>
    <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>
  </reference>
  <reference>
    <citation>Ahn JY, Sohn Y, Lee SH, Cho Y, Hyun JH, Baek YJ, Jeong SJ, Kim JH, Ku NS, Yeom JS, Roh J, Ahn MY, Chin BS, Kim YS, Lee H, Yong D, Kim HO, Kim S, Choi JY. Use of Convalescent Plasma Therapy in Two COVID-19 Patients with Acute Respiratory Distress Syndrome in Korea. J Korean Med Sci. 2020 Apr 13;35(14):e149. doi: 10.3346/jkms.2020.35.e149.</citation>
    <PMID>32281317</PMID>
  </reference>
  <reference>
    <citation>Ye M, Fu D, Ren Y, Wang F, Wang D, Zhang F, Xia X, Lv T. Treatment with convalescent plasma for COVID-19 patients in Wuhan, China. J Med Virol. 2020 Oct;92(10):1890-1901. doi: 10.1002/jmv.25882. Epub 2020 Jun 29.</citation>
    <PMID>32293713</PMID>
  </reference>
  <reference>
    <citation>Rajendran K, Krishnasamy N, Rangarajan J, Rathinam J, Natarajan M, Ramachandran A. Convalescent plasma transfusion for the treatment of COVID-19: Systematic review. J Med Virol. 2020 Sep;92(9):1475-1483. doi: 10.1002/jmv.25961. Epub 2020 May 12.</citation>
    <PMID>32356910</PMID>
  </reference>
  <reference>
    <citation>Joyner M, Wright RS, Fairweather D, Senefeld J, Bruno K, Klassen S, Carter R, Klompas A, Wiggins C, Shepherd JR, Rea R, Whelan E, Clayburn A, Spiegel M, Johnson P, Lesser E, Baker S, Larson K, Ripoll Sanz J, Andersen K, Hodge D, Kunze K, Buras M, Vogt M, Herasevich V, Dennis J, Regimbal R, Bauer P, Blair J, van Buskirk C, Winters J, Stubbs J, Paneth N, Casadevall A. Early Safety Indicators of COVID-19 Convalescent Plasma in 5,000 Patients. medRxiv. 2020 May 14:2020.05.12.20099879. doi: 10.1101/2020.05.12.20099879. Preprint.</citation>
    <PMID>32511566</PMID>
  </reference>
  <reference>
    <citation>Valk SJ, Piechotta V, Chai KL, Doree C, Monsef I, Wood EM, Lamikanra A, Kimber C, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a rapid review. Cochrane Database Syst Rev. 2020 May 14;5(5):CD013600. doi: 10.1002/14651858.CD013600.</citation>
    <PMID>32406927</PMID>
  </reference>
  <reference>
    <citation>Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16.</citation>
    <PMID>25030060</PMID>
  </reference>
  <reference>
    <citation>Guo L, Ren L, Yang S, Xiao M, Chang D, Yang F, Dela Cruz CS, Wang Y, Wu C, Xiao Y, Zhang L, Han L, Dang S, Xu Y, Yang QW, Xu SY, Zhu HD, Xu YC, Jin Q, Sharma L, Wang L, Wang J. Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19). Clin Infect Dis. 2020 Jul 28;71(15):778-785. doi: 10.1093/cid/ciaa310.</citation>
    <PMID>32198501</PMID>
  </reference>
  <reference>
    <citation>To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC, Yip CC, Cai JP, Chan JM, Chik TS, Lau DP, Choi CY, Chen LL, Chan WM, Chan KH, Ip JD, Ng AC, Poon RW, Luo CT, Cheng VC, Chan JF, Hung IF, Chen Z, Chen H, Yuen KY. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 May;20(5):565-574. doi: 10.1016/S1473-3099(20)30196-1. Epub 2020 Mar 23.</citation>
    <PMID>32213337</PMID>
  </reference>
  <reference>
    <citation>Luke TC, Casadevall A, Watowich SJ, Hoffman SL, Beigel JH, Burgess TH. Hark back: passive immunotherapy for influenza and other serious infections. Crit Care Med. 2010 Apr;38(4 Suppl):e66-73. doi: 10.1097/CCM.0b013e3181d44c1e.</citation>
    <PMID>20154602</PMID>
  </reference>
  <reference>
    <citation>Wong VW, Dai D, Wu AK, Sung JJ. Treatment of severe acute respiratory syndrome with convalescent plasma. Hong Kong Med J. 2003 Jun;9(3):199-201.</citation>
    <PMID>12777656</PMID>
  </reference>
  <reference>
    <citation>Kong LK, Zhou BP. Successful treatment of avian influenza with convalescent plasma. Hong Kong Med J. 2006 Dec;12(6):489. No abstract available.</citation>
    <PMID>17148811</PMID>
  </reference>
  <reference>
    <citation>Leider JP, Brunker PA, Ness PM. Convalescent transfusion for pandemic influenza: preparing blood banks for a new plasma product? Transfusion. 2010 Jun;50(6):1384-98. doi: 10.1111/j.1537-2995.2010.02590.x. Epub 2010 Feb 11.</citation>
    <PMID>20158681</PMID>
  </reference>
  <reference>
    <citation>Zhou B, Zhong N, Guan Y. Treatment with convalescent plasma for influenza A (H5N1) infection. N Engl J Med. 2007 Oct 4;357(14):1450-1. doi: 10.1056/NEJMc070359. No abstract available.</citation>
    <PMID>17914053</PMID>
  </reference>
  <reference>
    <citation>Wong HK, Lee CK, Hung IF, Leung JN, Hong J, Yuen KY, Lin CK. Practical limitations of convalescent plasma collection: a case scenario in pandemic preparation for influenza A (H1N1) infection. Transfusion. 2010 Sep;50(9):1967-71. doi: 10.1111/j.1537-2995.2010.02651.x.</citation>
    <PMID>20412524</PMID>
  </reference>
  <reference>
    <citation>Chen L, Xiong J, Bao L, Shi Y. Convalescent plasma as a potential therapy for COVID-19. Lancet Infect Dis. 2020 Apr;20(4):398-400. doi: 10.1016/S1473-3099(20)30141-9. Epub 2020 Feb 27. No abstract available.</citation>
    <PMID>32113510</PMID>
  </reference>
  <reference>
    <citation>Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available.</citation>
    <PMID>32167489</PMID>
  </reference>
  <reference>
    <citation>Chang L, Yan Y, Wang L. Coronavirus Disease 2019: Coronaviruses and Blood Safety. Transfus Med Rev. 2020 Apr;34(2):75-80. doi: 10.1016/j.tmrv.2020.02.003. Epub 2020 Feb 21.</citation>
    <PMID>32107119</PMID>
  </reference>
  <reference>
    <citation>Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19.</citation>
    <PMID>21248066</PMID>
  </reference>
  <reference>
    <citation>Roback JD, Guarner J. Convalescent Plasma to Treat COVID-19: Possibilities and Challenges. JAMA. 2020 Apr 28;323(16):1561-1562. doi: 10.1001/jama.2020.4940. No abstract available.</citation>
    <PMID>32219429</PMID>
  </reference>
  <reference>
    <citation>Toy P. Update on transfusion-related acute lung injury. Clin Adv Hematol Oncol. 2019 Jul;17(7):378-381. No abstract available.</citation>
    <PMID>31449502</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>August 23, 2021</last_update_submitted>
  <last_update_submitted_qc>August 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital de Infecciosas Francisco Javier Muniz</investigator_affiliation>
    <investigator_full_name>Carlos Alberto Gonzalez</investigator_full_name>
    <investigator_title>Blood Bank Director in Hospital de Infecciosas Francisco Javier Muniz</investigator_title>
  </responsible_party>
  <keyword>Convalescent plasma</keyword>
  <keyword>Covid-19 treatment</keyword>
  <keyword>Transfusion medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 25, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT04468009/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 16, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT04468009/ICF_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/NCT04468009
org study id: 1725
nct id: NCT04468009
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study aims to collect convalescent plasma and use it as experimental treatment in
      critically ill Covid-19 patients in order to reduce mortality and length of stay in intensive
      care unit.
This study aims to use convalescent plasma as experimental treatment in critically ill
      Covid-19 patients in order to reduce mortality and length of stay in intensive care unit.
      Donors must have anti-SARS CoV2 antibodies. Recipients must be critically ill Covid-19
      patients on mechanical ventilation.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mortality at ICU at 30 days
time frame: Mortality at 30 days
description: Mortality at 30 days of Intensive Care Unit (ICU) admission
measure: Mortality at ICU at 90 days
time frame: Mortality at 90 days
description: Mortality at 90 days of ICU admission
measure: SOFA score of study days 1, 3, 5, 7, 14 and 28
time frame: Study days 1, 3, 5, 7, 14 and 28
description: Sequential Organ Failure Assessment (SOFA) of study days 1, 3, 5, 7, 14 and 28
measure: Need for supportive therapy after enrollment
time frame: Duration of supportive therapy through study completion, an average of 3 months
description: Duration (number of days) of supportive therapy (oxygen and ventilation, dialysis, vasopressors) after enrollment
measure: Lenght of stay in ICU
time frame: Duration of stay in ICU through study completion, an average of 3 months
description: Duration (number of days) of stay in ICU between ICU admission and ICU final discharge
measure: Lenght of mechanical ventilation
time frame: Duration of mechanical ventilation through study completion, an average of 3 months
description: Duration (number of days) of mechanical ventilation between beginning and final liberation from mechanical ventilation
measure: Lenght of hospitalization
time frame: Duration of hospitalization through study completion, an average of 3 months
description: Duration (number of days) of hospitalization between hospital admission and final hospital discharge
measure: Lenght of hospitalization after ICU discharge
time frame: Duration (number of days) of hospitalization through study completion, an average of 3 months
description: Duration (number of days) of hospitalization after ICU discharge
measure: Days without ventilation after enrollment
time frame: Days without ventilation through study completion, an average of 3 months
description: Number of days without ventilation after enrollment
measure: Days without vasopressors after enrollment
time frame: Days without vasopressors through study completion, an average of 3 months
description: Number of days without vasopressors after enrollment
measure: Changes in Chest X-ray
time frame: Changes in Chest X-ray through study completion, an average of 3 months
description: Changes in Chest X-ray (unilateral, bilateral, unique, multiple, pleural effusion) after enrollment
arm group label: Standard of care
arm group type: No Intervention
description: Standard of care for Covid-19
arm group label: PCC-19
arm group type: Experimental
description: Treatment with convalescent plasma
intervention type: Biological
intervention name: Convalescent plasma
description: Convalescent plasma from patients recovering from Covid-19 and which had anti-SARS-Cov-2 antibodies
arm group label: PCC-19
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carlos A Gonzalez, MD
role: Principal Investigator
affiliation: Hospital de Infecciosas Francisco Javier Muniz
facility: 
country: Argentina
citation: Enria DA, Briggiler AM, Fernandez NJ, Levis SC, Maiztegui JI. Importance of dose of neutralising antibodies in treatment of Argentine haemorrhagic fever with immune plasma. Lancet. 1984 Aug 4;2(8397):255-6. doi: 10.1016/s0140-6736(84)90299-x.
PMID: 6146809
citation: Rojas M, Rodriguez Y, Monsalve DM, Acosta-Ampudia Y, Camacho B, Gallo JE, Rojas-Villarraga A, Ramirez-Santana C, Diaz-Coronado JC, Manrique R, Mantilla RD, Shoenfeld Y, Anaya JM. Convalescent plasma in Covid-19: Possible mechanisms of action. Autoimmun Rev. 2020 Jul;19(7):102554. doi: 10.1016/j.autrev.2020.102554. Epub 2020 May 5.
PMID: 32380316
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: Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.
PMID: 32219428
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.
PMID: 32243945
citation: Ahn JY, Sohn Y, Lee SH, Cho Y, Hyun JH, Baek YJ, Jeong SJ, Kim JH, Ku NS, Yeom JS, Roh J, Ahn MY, Chin BS, Kim YS, Lee H, Yong D, Kim HO, Kim S, Choi JY. Use of Convalescent Plasma Therapy in Two COVID-19 Patients with Acute Respiratory Distress Syndrome in Korea. J Korean Med Sci. 2020 Apr 13;35(14):e149. doi: 10.3346/jkms.2020.35.e149.
PMID: 32281317
citation: Ye M, Fu D, Ren Y, Wang F, Wang D, Zhang F, Xia X, Lv T. Treatment with convalescent plasma for COVID-19 patients in Wuhan, China. J Med Virol. 2020 Oct;92(10):1890-1901. doi: 10.1002/jmv.25882. Epub 2020 Jun 29.
PMID: 32293713
citation: Rajendran K, Krishnasamy N, Rangarajan J, Rathinam J, Natarajan M, Ramachandran A. Convalescent plasma transfusion for the treatment of COVID-19: Systematic review. J Med Virol. 2020 Sep;92(9):1475-1483. doi: 10.1002/jmv.25961. Epub 2020 May 12.
PMID: 32356910
citation: Joyner M, Wright RS, Fairweather D, Senefeld J, Bruno K, Klassen S, Carter R, Klompas A, Wiggins C, Shepherd JR, Rea R, Whelan E, Clayburn A, Spiegel M, Johnson P, Lesser E, Baker S, Larson K, Ripoll Sanz J, Andersen K, Hodge D, Kunze K, Buras M, Vogt M, Herasevich V, Dennis J, Regimbal R, Bauer P, Blair J, van Buskirk C, Winters J, Stubbs J, Paneth N, Casadevall A. Early Safety Indicators of COVID-19 Convalescent Plasma in 5,000 Patients. medRxiv. 2020 May 14:2020.05.12.20099879. doi: 10.1101/2020.05.12.20099879. Preprint.
PMID: 32511566
citation: Valk SJ, Piechotta V, Chai KL, Doree C, Monsef I, Wood EM, Lamikanra A, Kimber C, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a rapid review. Cochrane Database Syst Rev. 2020 May 14;5(5):CD013600. doi: 10.1002/14651858.CD013600.
PMID: 32406927
citation: Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16.
PMID: 25030060
citation: Guo L, Ren L, Yang S, Xiao M, Chang D, Yang F, Dela Cruz CS, Wang Y, Wu C, Xiao Y, Zhang L, Han L, Dang S, Xu Y, Yang QW, Xu SY, Zhu HD, Xu YC, Jin Q, Sharma L, Wang L, Wang J. Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19). Clin Infect Dis. 2020 Jul 28;71(15):778-785. doi: 10.1093/cid/ciaa310.
PMID: 32198501
citation: To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC, Yip CC, Cai JP, Chan JM, Chik TS, Lau DP, Choi CY, Chen LL, Chan WM, Chan KH, Ip JD, Ng AC, Poon RW, Luo CT, Cheng VC, Chan JF, Hung IF, Chen Z, Chen H, Yuen KY. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 May;20(5):565-574. doi: 10.1016/S1473-3099(20)30196-1. Epub 2020 Mar 23.
PMID: 32213337
citation: Luke TC, Casadevall A, Watowich SJ, Hoffman SL, Beigel JH, Burgess TH. Hark back: passive immunotherapy for influenza and other serious infections. Crit Care Med. 2010 Apr;38(4 Suppl):e66-73. doi: 10.1097/CCM.0b013e3181d44c1e.
PMID: 20154602
citation: Wong VW, Dai D, Wu AK, Sung JJ. Treatment of severe acute respiratory syndrome with convalescent plasma. Hong Kong Med J. 2003 Jun;9(3):199-201.
PMID: 12777656
citation: Kong LK, Zhou BP. Successful treatment of avian influenza with convalescent plasma. Hong Kong Med J. 2006 Dec;12(6):489. No abstract available.
PMID: 17148811
citation: Leider JP, Brunker PA, Ness PM. Convalescent transfusion for pandemic influenza: preparing blood banks for a new plasma product? Transfusion. 2010 Jun;50(6):1384-98. doi: 10.1111/j.1537-2995.2010.02590.x. Epub 2010 Feb 11.
PMID: 20158681
citation: Zhou B, Zhong N, Guan Y. Treatment with convalescent plasma for influenza A (H5N1) infection. N Engl J Med. 2007 Oct 4;357(14):1450-1. doi: 10.1056/NEJMc070359. No abstract available.
PMID: 17914053
citation: Wong HK, Lee CK, Hung IF, Leung JN, Hong J, Yuen KY, Lin CK. Practical limitations of convalescent plasma collection: a case scenario in pandemic preparation for influenza A (H1N1) infection. Transfusion. 2010 Sep;50(9):1967-71. doi: 10.1111/j.1537-2995.2010.02651.x.
PMID: 20412524
citation: Chen L, Xiong J, Bao L, Shi Y. Convalescent plasma as a potential therapy for COVID-19. Lancet Infect Dis. 2020 Apr;20(4):398-400. doi: 10.1016/S1473-3099(20)30141-9. Epub 2020 Feb 27. No abstract available.
PMID: 32113510
citation: Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available.
PMID: 32167489
citation: Chang L, Yan Y, Wang L. Coronavirus Disease 2019: Coronaviruses and Blood Safety. Transfus Med Rev. 2020 Apr;34(2):75-80. doi: 10.1016/j.tmrv.2020.02.003. Epub 2020 Feb 21.
PMID: 32107119
citation: Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19.
PMID: 21248066
citation: Roback JD, Guarner J. Convalescent Plasma to Treat COVID-19: Possibilities and Challenges. JAMA. 2020 Apr 28;323(16):1561-1562. doi: 10.1001/jama.2020.4940. No abstract available.
PMID: 32219429
citation: Toy P. Update on transfusion-related acute lung injury. Clin Adv Hematol Oncol. 2019 Jul;17(7):378-381. No abstract available.
PMID: 31449502
responsible party type: Principal Investigator
investigator affiliation: Hospital de Infecciosas Francisco Javier Muniz
investigator full name: Carlos Alberto Gonzalez
investigator title: Blood Bank Director in Hospital de Infecciosas Francisco Javier Muniz
mesh term: COVID-19
mesh term: Severe Acute Respiratory Syndrome
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