<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/NCT04467151</url>
  </required_header>
  <id_info>
    <org_study_id>HS-20-00516</org_study_id>
    <nct_id>NCT04467151</nct_id>
  </id_info>
  <brief_title>Administration of Anti-SARS-CoV-2 Convalescent Plasma in Hospitalized, Non-ICU Patients With COVID-19</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled Trial of Anti-SARS-CoV-2 Plasma in Hospitalized Non-ICU Patients With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kashif Khan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy and safety of the administration of&#xD;
      anti-SARS-CoV-2 convalescent plasma in COVID-19 patients who are sick enough to warrant&#xD;
      hospitalization, but not yet admitted to the ICU (prior to the onset of overwhelming disease&#xD;
      including a systemic inflammatory response, sepsis, and/or ARDS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized, double-blind, placebo-controlled trial to evaluate the safety and&#xD;
      efficacy of anti-SARS-CoV-2 convalescent plasma in COVID-19 patients.&#xD;
&#xD;
      After confirmation of COVID-19, patients that meet the eligibility requirement and provide&#xD;
      informed consent will be randomized in a 2:1 ratio to anti-SARS-CoV-2 convalescent plasma (1&#xD;
      unit of approximately 250 ml) or placebo (1 unit albumin 5%, approximately 250 ml). We will&#xD;
      evaluate the ability of anti-SARS-CoV-2 convalescent plasma vs. placebo control to decrease&#xD;
      disease progression (measured by the WHO Ordinal Scale for Clinical Improvement) during the&#xD;
      28 days following administration to hospitalized, non-ICU patients. If patient is discharged&#xD;
      from the hospital prior to Day 28, Day 28 assessment will be by phone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Did not obtain funding to proceed with study&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">October 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease progression measured by WHO scale</measure>
    <time_frame>Day 0 through Day 28 (or hospital discharge)</time_frame>
    <description>Disease progression from the state at randomization (with a &quot;3&quot; or &quot;4&quot; on the WHO Ordinal Scale for Clinical Improvement) to requiring invasive mechanical ventilation (which is &quot;6&quot; or greater on the WHO scale) during the study period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of maximum WHO score per group</measure>
    <time_frame>Day 0 through Day 28 (or hospital discharge)</time_frame>
    <description>Comparison of the number of participants reaching a maximum daily WHO score of 5, 7, and 8 during the study period per group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of decrease of median and maximum WHO score per group</measure>
    <time_frame>Day 0 through Day 28 (or hospital discharge)</time_frame>
    <description>Comparison of the median and maximum daily WHO scores during the study period per group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of time to clinical improvement per group</measure>
    <time_frame>Day 0 through Day 28 (or hospital discharge)</time_frame>
    <description>Comparison of time to clinical improvement, defined as time between randomization and time to improvement (WHO Ordinal Scale &quot;2&quot; first reached for at least 1 day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of time to reach score of &quot;6&quot; or greater on the WHO scale</measure>
    <time_frame>Day 0 through Day 28 (or hospital discharge)</time_frame>
    <description>Evaluate the time to reach score of at least 6 within 28 days</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Comparison of hospital length of stay per group</measure>
    <time_frame>Day 0 through Day 28 (or hospital discharge)</time_frame>
    <description>Evaluate number of days hospitalized</description>
  </other_outcome>
  <other_outcome>
    <measure>Comparison of ICU length of stay per group</measure>
    <time_frame>Day 0 through Day 28 (or hospital discharge)</time_frame>
    <description>Evaluate number of hours in the ICU</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>anti-SARS-CoV-2 plasma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive one dose (250-300ml) of anti-SARS-CoV-2 convalescent plasma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients receive one dose (250-300ml) of placebo (albumin 5%)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>anti-SARS-CoV-2 plasma</intervention_name>
    <description>Administration of anti-SARS-CoV-2 convalescent plasma</description>
    <arm_group_label>anti-SARS-CoV-2 plasma</arm_group_label>
    <other_name>Convalescent Plasma</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administration of placebo (albumin 5%)</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Albumin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ≥18 years of age&#xD;
&#xD;
          -  Hospitalized with COVID-19-related acute respiratory symptoms&#xD;
&#xD;
          -  Initial COVID-19 severity status on the WHO Ordinal Scale for Clinical Improvement = 3&#xD;
             (&quot;Hospitalized, no oxygen therapy) or 4 (&quot;Hospitalized, on oxygen by mask or nasal&#xD;
             prongs&quot;)&#xD;
&#xD;
          -  Laboratory-confirmed COVID-19&#xD;
&#xD;
          -  First signs of infection occurring no more than 14 days prior to enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receipt of pooled immunoglobulin in the past 30 days&#xD;
&#xD;
          -  Contraindication to transfusion or history of prior reactions to transfusion blood&#xD;
             products&#xD;
&#xD;
          -  Admission to intensive care unit at any point during hospital course prior to&#xD;
             enrollment&#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>Kashif T Khan, MD, SM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Keck School of Medicine of University of Southern California</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <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>Casadevall A, Scharff MD. Return to the past: the case for antibody-based therapies in infectious diseases. Clin Infect Dis. 1995 Jul;21(1):150-61. doi: 10.1093/clinids/21.1.150.</citation>
    <PMID>7578724</PMID>
  </reference>
  <reference>
    <citation>Casadevall A, Dadachova E, Pirofski LA. Passive antibody therapy for infectious diseases. Nat Rev Microbiol. 2004 Sep;2(9):695-703. doi: 10.1038/nrmicro974.</citation>
    <PMID>15372080</PMID>
  </reference>
  <reference>
    <citation>Casadevall A, Pirofski LA. The damage-response framework of microbial pathogenesis. Nat Rev Microbiol. 2003 Oct;1(1):17-24. doi: 10.1038/nrmicro732.</citation>
    <PMID>15040176</PMID>
  </reference>
  <reference>
    <citation>Casadevall A, Scharff MD. Serum therapy revisited: animal models of infection and development of passive antibody therapy. Antimicrob Agents Chemother. 1994 Aug;38(8):1695-702. doi: 10.1128/AAC.38.8.1695. No abstract available.</citation>
    <PMID>7985997</PMID>
  </reference>
  <reference>
    <citation>Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9.</citation>
    <PMID>15616839</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>Ko JH, Seok H, Cho SY, Ha YE, Baek JY, Kim SH, Kim YJ, Park JK, Chung CR, Kang ES, Cho D, Muller MA, Drosten C, Kang CI, Chung DR, Song JH, Peck KR. Challenges of convalescent plasma infusion therapy in Middle East respiratory coronavirus infection: a single centre experience. Antivir Ther. 2018;23(7):617-622. doi: 10.3851/IMP3243. Epub 2018 Jun 20.</citation>
    <PMID>29923831</PMID>
  </reference>
  <reference>
    <citation>Arabi YM, Hajeer AH, Luke T, Raviprakash K, Balkhy H, Johani S, Al-Dawood A, Al-Qahtani S, Al-Omari A, Al-Hameed F, Hayden FG, Fowler R, Bouchama A, Shindo N, Al-Khairy K, Carson G, Taha Y, Sadat M, Alahmadi M. Feasibility of Using Convalescent Plasma Immunotherapy for MERS-CoV Infection, Saudi Arabia. Emerg Infect Dis. 2016 Sep;22(9):1554-61. doi: 10.3201/eid2209.151164.</citation>
    <PMID>27532807</PMID>
  </reference>
  <reference>
    <citation>Sahr F, Ansumana R, Massaquoi TA, Idriss BR, Sesay FR, Lamin JM, Baker S, Nicol S, Conton B, Johnson W, Abiri OT, Kargbo O, Kamara P, Goba A, Russell JB, Gevao SM. Evaluation of convalescent whole blood for treating Ebola Virus Disease in Freetown, Sierra Leone. J Infect. 2017 Mar;74(3):302-309. doi: 10.1016/j.jinf.2016.11.009. Epub 2016 Nov 17.</citation>
    <PMID>27867062</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>Wan Y, Shang J, Sun S, Tai W, Chen J, Geng Q, He L, Chen Y, Wu J, Shi Z, Zhou Y, Du L, Li F. Molecular Mechanism for Antibody-Dependent Enhancement of Coronavirus Entry. J Virol. 2020 Feb 14;94(5):e02015-19. doi: 10.1128/JVI.02015-19. Print 2020 Feb 14.</citation>
    <PMID>31826992</PMID>
  </reference>
  <reference>
    <citation>Crowe JE Jr, Firestone CY, Murphy BR. Passively acquired antibodies suppress humoral but not cell-mediated immunity in mice immunized with live attenuated respiratory syncytial virus vaccines. J Immunol. 2001 Oct 1;167(7):3910-8. doi: 10.4049/jimmunol.167.7.3910.</citation>
    <PMID>11564809</PMID>
  </reference>
  <reference>
    <citation>van Griensven J, Edwards T, Gallian P; Ebola-Tx Consortium. Convalescent Plasma for Ebola Virus Disease. N Engl J Med. 2016 Jun 23;374(25):2500. doi: 10.1056/NEJMc1602284. No abstract available.</citation>
    <PMID>27332913</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>
  <verification_date>October 2020</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 10, 2020</study_first_posted>
  <last_update_submitted>October 20, 2020</last_update_submitted>
  <last_update_submitted_qc>October 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Kashif Khan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Anti-SARS-CoV-2 plasma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04467151
org study id: HS-20-00516
nct id: NCT04467151
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the efficacy and safety of the administration of
      anti-SARS-CoV-2 convalescent plasma in COVID-19 patients who are sick enough to warrant
      hospitalization, but not yet admitted to the ICU (prior to the onset of overwhelming disease
      including a systemic inflammatory response, sepsis, and/or ARDS).
This study is a randomized, double-blind, placebo-controlled trial to evaluate the safety and
      efficacy of anti-SARS-CoV-2 convalescent plasma in COVID-19 patients.

      After confirmation of COVID-19, patients that meet the eligibility requirement and provide
      informed consent will be randomized in a 2:1 ratio to anti-SARS-CoV-2 convalescent plasma (1
      unit of approximately 250 ml) or placebo (1 unit albumin 5%, approximately 250 ml). We will
      evaluate the ability of anti-SARS-CoV-2 convalescent plasma vs. placebo control to decrease
      disease progression (measured by the WHO Ordinal Scale for Clinical Improvement) during the
      28 days following administration to hospitalized, non-ICU patients. If patient is discharged
      from the hospital prior to Day 28, Day 28 assessment will be by phone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Disease progression measured by WHO scale
time frame: Day 0 through Day 28 (or hospital discharge)
description: Disease progression from the state at randomization (with a "3" or "4" on the WHO Ordinal Scale for Clinical Improvement) to requiring invasive mechanical ventilation (which is "6" or greater on the WHO scale) during the study period
measure: Comparison of maximum WHO score per group
time frame: Day 0 through Day 28 (or hospital discharge)
description: Comparison of the number of participants reaching a maximum daily WHO score of 5, 7, and 8 during the study period per group
measure: Comparison of decrease of median and maximum WHO score per group
time frame: Day 0 through Day 28 (or hospital discharge)
description: Comparison of the median and maximum daily WHO scores during the study period per group
measure: Comparison of time to clinical improvement per group
time frame: Day 0 through Day 28 (or hospital discharge)
description: Comparison of time to clinical improvement, defined as time between randomization and time to improvement (WHO Ordinal Scale "2" first reached for at least 1 day)
measure: Comparison of time to reach score of "6" or greater on the WHO scale
time frame: Day 0 through Day 28 (or hospital discharge)
description: Evaluate the time to reach score of at least 6 within 28 days
measure: Comparison of hospital length of stay per group
time frame: Day 0 through Day 28 (or hospital discharge)
description: Evaluate number of days hospitalized
measure: Comparison of ICU length of stay per group
time frame: Day 0 through Day 28 (or hospital discharge)
description: Evaluate number of hours in the ICU
arm group label: anti-SARS-CoV-2 plasma
arm group type: Experimental
description: Patients receive one dose (250-300ml) of anti-SARS-CoV-2 convalescent plasma
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients receive one dose (250-300ml) of placebo (albumin 5%)
intervention type: Drug
intervention name: anti-SARS-CoV-2 plasma
description: Administration of anti-SARS-CoV-2 convalescent plasma
arm group label: anti-SARS-CoV-2 plasma
other name: Convalescent Plasma
intervention type: Other
intervention name: Placebo
description: Administration of placebo (albumin 5%)
arm group label: Placebo
other name: Albumin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kashif T Khan, MD, SM
role: Principal Investigator
affiliation: Keck School of Medicine of University of Southern California
country: United States
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: Casadevall A, Scharff MD. Return to the past: the case for antibody-based therapies in infectious diseases. Clin Infect Dis. 1995 Jul;21(1):150-61. doi: 10.1093/clinids/21.1.150.
PMID: 7578724
citation: Casadevall A, Dadachova E, Pirofski LA. Passive antibody therapy for infectious diseases. Nat Rev Microbiol. 2004 Sep;2(9):695-703. doi: 10.1038/nrmicro974.
PMID: 15372080
citation: Casadevall A, Pirofski LA. The damage-response framework of microbial pathogenesis. Nat Rev Microbiol. 2003 Oct;1(1):17-24. doi: 10.1038/nrmicro732.
PMID: 15040176
citation: Casadevall A, Scharff MD. Serum therapy revisited: animal models of infection and development of passive antibody therapy. Antimicrob Agents Chemother. 1994 Aug;38(8):1695-702. doi: 10.1128/AAC.38.8.1695. No abstract available.
PMID: 7985997
citation: Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9.
PMID: 15616839
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: Ko JH, Seok H, Cho SY, Ha YE, Baek JY, Kim SH, Kim YJ, Park JK, Chung CR, Kang ES, Cho D, Muller MA, Drosten C, Kang CI, Chung DR, Song JH, Peck KR. Challenges of convalescent plasma infusion therapy in Middle East respiratory coronavirus infection: a single centre experience. Antivir Ther. 2018;23(7):617-622. doi: 10.3851/IMP3243. Epub 2018 Jun 20.
PMID: 29923831
citation: Arabi YM, Hajeer AH, Luke T, Raviprakash K, Balkhy H, Johani S, Al-Dawood A, Al-Qahtani S, Al-Omari A, Al-Hameed F, Hayden FG, Fowler R, Bouchama A, Shindo N, Al-Khairy K, Carson G, Taha Y, Sadat M, Alahmadi M. Feasibility of Using Convalescent Plasma Immunotherapy for MERS-CoV Infection, Saudi Arabia. Emerg Infect Dis. 2016 Sep;22(9):1554-61. doi: 10.3201/eid2209.151164.
PMID: 27532807
citation: Sahr F, Ansumana R, Massaquoi TA, Idriss BR, Sesay FR, Lamin JM, Baker S, Nicol S, Conton B, Johnson W, Abiri OT, Kargbo O, Kamara P, Goba A, Russell JB, Gevao SM. Evaluation of convalescent whole blood for treating Ebola Virus Disease in Freetown, Sierra Leone. J Infect. 2017 Mar;74(3):302-309. doi: 10.1016/j.jinf.2016.11.009. Epub 2016 Nov 17.
PMID: 27867062
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: Wan Y, Shang J, Sun S, Tai W, Chen J, Geng Q, He L, Chen Y, Wu J, Shi Z, Zhou Y, Du L, Li F. Molecular Mechanism for Antibody-Dependent Enhancement of Coronavirus Entry. J Virol. 2020 Feb 14;94(5):e02015-19. doi: 10.1128/JVI.02015-19. Print 2020 Feb 14.
PMID: 31826992
citation: Crowe JE Jr, Firestone CY, Murphy BR. Passively acquired antibodies suppress humoral but not cell-mediated immunity in mice immunized with live attenuated respiratory syncytial virus vaccines. J Immunol. 2001 Oct 1;167(7):3910-8. doi: 10.4049/jimmunol.167.7.3910.
PMID: 11564809
citation: van Griensven J, Edwards T, Gallian P; Ebola-Tx Consortium. Convalescent Plasma for Ebola Virus Disease. N Engl J Med. 2016 Jun 23;374(25):2500. doi: 10.1056/NEJMc1602284. No abstract available.
PMID: 27332913
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
responsible party type: Sponsor-Investigator
investigator affiliation: University of Southern California
investigator full name: Kashif Khan
investigator title: Principal Investigator
mesh term: COVID-19
sharing ipd: Undecided