<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/NCT04405310</url>
  </required_header>
  <id_info>
    <org_study_id>DI/20/201/04/19</org_study_id>
    <nct_id>NCT04405310</nct_id>
  </id_info>
  <brief_title>Convalescent Plasma of Covid-19 to Treat SARS-COV-2 a Randomized Doble Blind 2 Center Trial</brief_title>
  <acronym>CPC-SARS</acronym>
  <official_title>Plasma From Covalescent Donors With Covid-19 for the Management of Patients With SARS-COV-2 Fase II and III, a Doble Center Randomized Doble Blind Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grupo Mexicano para el Estudio de la Medicina Intensiva</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital General Naval de Alta Especialidad - Escuela Medico Naval</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Pediatrics, Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto Nacional de Enfermedades Respiratorias</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Grupo Mexicano para el Estudio de la Medicina Intensiva</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>
      The new SARS-CoV-2 coronavirus is an emerging virus originating in Wuhan, China that has&#xD;
      spread rapidly throughout the world. As of March 24, 2020, China had reported 81,767 cases&#xD;
      with 3,281 deaths, and the World Health Organization (WHO) declared coronavirus 19 (COVID-19)&#xD;
      a pandemic. COVID-19 disease is currently a pandemic without specific therapeutic agents and&#xD;
      substantial mortality. So it is of utmost importance to find new treatments. Various&#xD;
      therapies, such as Remdesivir and Favipiravir, are being investigated but the antiviral&#xD;
      efficacy of these drugs is not yet known. The use of convalescent plasma was used as an&#xD;
      empirical treatment during the Ebola virus outbreaks in 2014 and in 2015 a protocol was&#xD;
      established for the treatment of the Middle East respiratory syndrome coronavirus (MERS) with&#xD;
      convalescent plasma. This approach with other viral infections such as SARS-CoV, H5N1 avian&#xD;
      influenza and H1N1 influenza suggesting that plasma transfusion from convalescent donors was&#xD;
      effective.&#xD;
&#xD;
      For this study, plasma from convalescent donors will be collected from those donors who have&#xD;
      recovered from SARS-CoV-2 and are between 10 and 14 days after illness. Immunoassays will be&#xD;
      carried out to detect total IgM and IgG antibodies against SARS-CoV-2. Patients will receive&#xD;
      1 to 3 convalescent plasma transfusions, depending on the response to treatment.&#xD;
&#xD;
      The expected results are: normal body temperature, decrease in viral load or negative between&#xD;
      10-12 days after transfusion of convalescent plasma, which does not progress to ARDS,&#xD;
      extubation of mechanical ventilation within two weeks of treatment, recovery of patient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, SARS-CoV-2 disease represents a Public Health emergency of international concern.&#xD;
      The new coronavirus COVID-19 is estimated to have infected more than 1.8 million people&#xD;
      worldwide. The WHO estimates that the contagion rate (R0) of the virus is 1.4 to 2.5, which&#xD;
      affects its exponential replication. In the absence of an effective treatment for SARS-CoV-2&#xD;
      disease, there is an urgent need to evaluate therapeutic alternatives that reduce the&#xD;
      mortality and morbidity of this virus. There is scientific evidence that supports the use of&#xD;
      convalescent donor plasma for the treatment of emerging virus outbreaks and suggests that the&#xD;
      transfusion of convalescent donor plasma is effective, and therefore the following question&#xD;
      is established:&#xD;
&#xD;
      The use of plasma from convalescent donors by COVID-19 in patients with SARS-CoV-2 disease,&#xD;
      stage II (moderate) and III (severe), is a treatment that reduces mortality?&#xD;
&#xD;
      Given that the mortality rate is a very relevant fact, which concerns the general population,&#xD;
      the clinical treatments that can be used to reduce the mortality rate of critical cases are&#xD;
      of great relevance. There are patients recovered from COVID-19 who are potential plasma&#xD;
      donors, and in turn, many critical patients who need to receive it.&#xD;
&#xD;
      Currently, there are no effective treatments to address COVID-19 disease. A recent WHO report&#xD;
      indicates that early results with the use of convalescent plasma suggest that it may be a&#xD;
      potentially useful treatment modality for severe SARS-CoV-2 disease. The use of convalescent&#xD;
      plasma from COVID-19 in acute infected patients is currently considered an experimental&#xD;
      therapy. This implies the need to promote clinical trials in order to demonstrate their&#xD;
      efficacy. It is recommended that the entire process from donor selection, processing,&#xD;
      labeling, storage and distribution to be carried out in a specifically licensed institution.&#xD;
      These institutions must have all the guarantees that prove the correct practice of the&#xD;
      procedures.&#xD;
&#xD;
      The use of convalescent plasma has been used as rescue therapy in patients with SARS whose&#xD;
      condition continues to deteriorate despite treatment with methylprednisolone pulses, in&#xD;
      addition, different studies have shown a decrease in hospital stay, and lower mortality in&#xD;
      patients treated with convalescent plasma compared to those in which this treatment was not&#xD;
      used.&#xD;
&#xD;
      A multicenter randomized study by Hung showed that the use of convalescent plasma in patients&#xD;
      with type A H1N1 influenza was associated with a lower viral load and a reduction in&#xD;
      mortality 5 days after the onset of symptoms. A Mair-Jenkins meta-analysis showed that&#xD;
      mortality was reduced after several doses of convalescent plasma, and another meta-analysis&#xD;
      by Luke identified in 1703 patients with influenza pneumonia (1918-1925) that the use of&#xD;
      convalescent plasma blood products an absolute reduction. 21% (95% CI 15-27; p = 0.001) in&#xD;
      crude fatality with low risk of bias.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Actual">December 10, 2020</completion_date>
  <primary_completion_date type="Actual">November 20, 2020</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>
    <intervention_model_description>Parallel assignment, relationship 3.2.3</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>parallel design 3:2:3</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Death</measure>
    <time_frame>15 days</time_frame>
    <description>any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lenth of stay ICU</measure>
    <time_frame>15 days</time_frame>
    <description>Time for discharge from the ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of Mechanical Ventilation</measure>
    <time_frame>15 days</time_frame>
    <description>Number of days with ventilatory support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suplemental Oxigen support</measure>
    <time_frame>15 days</time_frame>
    <description>Number of days with need of oxigen suport without Mechanical Ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral Load by RT-PCR</measure>
    <time_frame>15 days</time_frame>
    <description>changes in viral load</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflamatory biomarkers</measure>
    <time_frame>15 days</time_frame>
    <description>changes in pro- inflamatory and anti-inflamatory biomarkes (IL-6, PCR, Ferritine, D Dimer, IL-8 IL-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SOFA (sequencial Organ Failure Assesment)</measure>
    <time_frame>15 days</time_frame>
    <description>changes in SOFA scale</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>SARS Pneumonia</condition>
  <arm_group>
    <arm_group_label>EXP-PC-F2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with Pneumonia due to SARS-COV-2 phase 2 with Hyperimmune Plasma from Convalescent patients and conventional Therapy (Azithromycin and Hydroxychloroquine)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EXP-NONPC-F2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>20 Patients with Pneumonia due to SARS-COV-2 phase 2 with conventional Therapy (Azithromycin and Hydroxychloroquine) and 20% Albumin in Hartman Solution.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EXP-PC-F3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 Patients with Pneumonia due to SARS-VOC-2 phase 3 with Hyperimmune Plasma from Convalescent patients and conventional Therapy (Azithromycin and Hydroxychloroquine)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EXP-NONPC-F3</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>20 Patients with Pneumonia due to SARS-VOC-2 phase 3 with conventional Therapy (Azithromycin and Hydroxychloroquine) and 20% Albumin in Hartman Solution.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Convalescent Plasma of patients with COVID-19</intervention_name>
    <description>Convalescent Plasma from patients with covid-19 by Apheresis, the maximum plasma volume withdrawn per session should not exceed 600 mL, excluding the anticoagulant volume, or 16% of the total blood volume, in the absence of volumetric replacement.</description>
    <arm_group_label>EXP-PC-F2</arm_group_label>
    <arm_group_label>EXP-PC-F3</arm_group_label>
    <other_name>Hyperinmunne plasma</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>placebo (hartmann plus albumine)</intervention_name>
    <description>use of albumin 20% in 250cc of Hartmann solution</description>
    <arm_group_label>EXP-NONPC-F2</arm_group_label>
    <arm_group_label>EXP-NONPC-F3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 18 to 70 years of age.&#xD;
&#xD;
          -  Serious or critically ill patients confirmed for SARS-CoV-2 disease (RT-PCR).&#xD;
&#xD;
          -  Meet the criteria for Disease with SARS-CoV-2 disease, phase II (Moderate) and phase&#xD;
             III (severe) .&#xD;
&#xD;
          -  Suspected Cytokine Release Syndrome with Hscore 169 points.&#xD;
&#xD;
          -  Presence of severe acute hypoxemia with SpO2 &lt;90% in ambient air and / or PaO2 / FiO2&#xD;
             &lt;300 mmHg.&#xD;
&#xD;
          -  Meet criteria (plain chest tomography or plain chest radiograph) for SARS-CoV-2&#xD;
             disease.&#xD;
&#xD;
          -  Supplemental oxygen requirement either through the facial store plus reservoir bag,&#xD;
             high-flow nasal tips or advanced airway management and invasive mechanical ventilation&#xD;
             support.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient has no interest in participating in the trial.&#xD;
&#xD;
          -  Bilateral pulmonary infiltrate related to heart failure or other cause of water&#xD;
             overload.&#xD;
&#xD;
          -  Virus positive respiratory viral panel other than COVID-19&#xD;
&#xD;
          -  History of allergy to plasma, sodium citrate, or methylene blue.&#xD;
&#xD;
          -  Patients with a history of autoimmune diseases or selective IgA insufficiency.&#xD;
&#xD;
          -  Those patients who are participating in other protocols.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ORLANDO CARILLO-TORRES, PHD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital General de Mexico Dr. Eduardo Liceaga</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Nava de Alta Especialidad</name>
      <address>
        <city>Mexico City</city>
        <zip>04470</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Mexico Dr Eduardo Liceaga</name>
      <address>
        <city>Mexico City</city>
        <zip>06720</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <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>Lu H. Drug treatment options for the 2019-new coronavirus (2019-nCoV). Biosci Trends. 2020 Mar 16;14(1):69-71. doi: 10.5582/bst.2020.01020. Epub 2020 Jan 28.</citation>
    <PMID>31996494</PMID>
  </reference>
  <reference>
    <citation>Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.</citation>
    <PMID>32091533</PMID>
  </reference>
  <reference>
    <citation>van Griensven J, Edwards T, de Lamballerie X, Semple MG, Gallian P, Baize S, Horby PW, Raoul H, Magassouba N, Antierens A, Lomas C, Faye O, Sall AA, Fransen K, Buyze J, Ravinetto R, Tiberghien P, Claeys Y, De Crop M, Lynen L, Bah EI, Smith PG, Delamou A, De Weggheleire A, Haba N; Ebola-Tx Consortium. Evaluation of Convalescent Plasma for Ebola Virus Disease in Guinea. N Engl J Med. 2016 Jan 7;374(1):33-42. doi: 10.1056/NEJMoa1511812.</citation>
    <PMID>26735992</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>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>December 16, 2020</last_update_submitted>
  <last_update_submitted_qc>December 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Grupo Mexicano para el Estudio de la Medicina Intensiva</investigator_affiliation>
    <investigator_full_name>Angel Augusto Perez Calatayud</investigator_full_name>
    <investigator_title>Head of division of critical care</investigator_title>
  </responsible_party>
  <keyword>SARS-COV-2, CONVALESCENT PLASMA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD will be shared by petition.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>3 months after completion up to five years</ipd_time_frame>
    <ipd_access_criteria>proposal should be directed to gmemiinv@gmails.com, to gain access, requestor will need to sign a data access agreement</ipd_access_criteria>
  </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/NCT04405310
org study id: DI/20/201/04/19
nct id: NCT04405310
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The new SARS-CoV-2 coronavirus is an emerging virus originating in Wuhan, China that has
      spread rapidly throughout the world. As of March 24, 2020, China had reported 81,767 cases
      with 3,281 deaths, and the World Health Organization (WHO) declared coronavirus 19 (COVID-19)
      a pandemic. COVID-19 disease is currently a pandemic without specific therapeutic agents and
      substantial mortality. So it is of utmost importance to find new treatments. Various
      therapies, such as Remdesivir and Favipiravir, are being investigated but the antiviral
      efficacy of these drugs is not yet known. The use of convalescent plasma was used as an
      empirical treatment during the Ebola virus outbreaks in 2014 and in 2015 a protocol was
      established for the treatment of the Middle East respiratory syndrome coronavirus (MERS) with
      convalescent plasma. This approach with other viral infections such as SARS-CoV, H5N1 avian
      influenza and H1N1 influenza suggesting that plasma transfusion from convalescent donors was
      effective.

      For this study, plasma from convalescent donors will be collected from those donors who have
      recovered from SARS-CoV-2 and are between 10 and 14 days after illness. Immunoassays will be
      carried out to detect total IgM and IgG antibodies against SARS-CoV-2. Patients will receive
      1 to 3 convalescent plasma transfusions, depending on the response to treatment.

      The expected results are: normal body temperature, decrease in viral load or negative between
      10-12 days after transfusion of convalescent plasma, which does not progress to ARDS,
      extubation of mechanical ventilation within two weeks of treatment, recovery of patient.
Currently, SARS-CoV-2 disease represents a Public Health emergency of international concern.
      The new coronavirus COVID-19 is estimated to have infected more than 1.8 million people
      worldwide. The WHO estimates that the contagion rate (R0) of the virus is 1.4 to 2.5, which
      affects its exponential replication. In the absence of an effective treatment for SARS-CoV-2
      disease, there is an urgent need to evaluate therapeutic alternatives that reduce the
      mortality and morbidity of this virus. There is scientific evidence that supports the use of
      convalescent donor plasma for the treatment of emerging virus outbreaks and suggests that the
      transfusion of convalescent donor plasma is effective, and therefore the following question
      is established:

      The use of plasma from convalescent donors by COVID-19 in patients with SARS-CoV-2 disease,
      stage II (moderate) and III (severe), is a treatment that reduces mortality?

      Given that the mortality rate is a very relevant fact, which concerns the general population,
      the clinical treatments that can be used to reduce the mortality rate of critical cases are
      of great relevance. There are patients recovered from COVID-19 who are potential plasma
      donors, and in turn, many critical patients who need to receive it.

      Currently, there are no effective treatments to address COVID-19 disease. A recent WHO report
      indicates that early results with the use of convalescent plasma suggest that it may be a
      potentially useful treatment modality for severe SARS-CoV-2 disease. The use of convalescent
      plasma from COVID-19 in acute infected patients is currently considered an experimental
      therapy. This implies the need to promote clinical trials in order to demonstrate their
      efficacy. It is recommended that the entire process from donor selection, processing,
      labeling, storage and distribution to be carried out in a specifically licensed institution.
      These institutions must have all the guarantees that prove the correct practice of the
      procedures.

      The use of convalescent plasma has been used as rescue therapy in patients with SARS whose
      condition continues to deteriorate despite treatment with methylprednisolone pulses, in
      addition, different studies have shown a decrease in hospital stay, and lower mortality in
      patients treated with convalescent plasma compared to those in which this treatment was not
      used.

      A multicenter randomized study by Hung showed that the use of convalescent plasma in patients
      with type A H1N1 influenza was associated with a lower viral load and a reduction in
      mortality 5 days after the onset of symptoms. A Mair-Jenkins meta-analysis showed that
      mortality was reduced after several doses of convalescent plasma, and another meta-analysis
      by Luke identified in 1703 patients with influenza pneumonia (1918-1925) that the use of
      convalescent plasma blood products an absolute reduction. 21% (95% CI 15-27; p = 0.001) in
      crude fatality with low risk of bias.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel assignment, relationship 3.2.3
primary purpose: Treatment
masking: Double (Participant, Care Provider)
masking description: parallel design 3:2:3
measure: Death
time frame: 15 days
description: any cause
measure: Lenth of stay ICU
time frame: 15 days
description: Time for discharge from the ICU
measure: Days of Mechanical Ventilation
time frame: 15 days
description: Number of days with ventilatory support
measure: Suplemental Oxigen support
time frame: 15 days
description: Number of days with need of oxigen suport without Mechanical Ventilation
measure: Viral Load by RT-PCR
time frame: 15 days
description: changes in viral load
measure: Inflamatory biomarkers
time frame: 15 days
description: changes in pro- inflamatory and anti-inflamatory biomarkes (IL-6, PCR, Ferritine, D Dimer, IL-8 IL-10
measure: SOFA (sequencial Organ Failure Assesment)
time frame: 15 days
description: changes in SOFA scale
arm group label: EXP-PC-F2
arm group type: Experimental
description: Patients with Pneumonia due to SARS-COV-2 phase 2 with Hyperimmune Plasma from Convalescent patients and conventional Therapy (Azithromycin and Hydroxychloroquine)
arm group label: EXP-NONPC-F2
arm group type: Placebo Comparator
description: 20 Patients with Pneumonia due to SARS-COV-2 phase 2 with conventional Therapy (Azithromycin and Hydroxychloroquine) and 20% Albumin in Hartman Solution.
arm group label: EXP-PC-F3
arm group type: Experimental
description: 20 Patients with Pneumonia due to SARS-VOC-2 phase 3 with Hyperimmune Plasma from Convalescent patients and conventional Therapy (Azithromycin and Hydroxychloroquine)
arm group label: EXP-NONPC-F3
arm group type: Placebo Comparator
description: 20 Patients with Pneumonia due to SARS-VOC-2 phase 3 with conventional Therapy (Azithromycin and Hydroxychloroquine) and 20% Albumin in Hartman Solution.
intervention type: Biological
intervention name: Convalescent Plasma of patients with COVID-19
description: Convalescent Plasma from patients with covid-19 by Apheresis, the maximum plasma volume withdrawn per session should not exceed 600 mL, excluding the anticoagulant volume, or 16% of the total blood volume, in the absence of volumetric replacement.
arm group label: EXP-PC-F2
arm group label: EXP-PC-F3
other name: Hyperinmunne plasma
intervention type: Other
intervention name: placebo (hartmann plus albumine)
description: use of albumin 20% in 250cc of Hartmann solution
arm group label: EXP-NONPC-F2
arm group label: EXP-NONPC-F3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: ORLANDO CARILLO-TORRES, PHD
role: Study Chair
affiliation: Hospital General de Mexico Dr. Eduardo Liceaga
facility: 
facility: 
country: Mexico
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: Lu H. Drug treatment options for the 2019-new coronavirus (2019-nCoV). Biosci Trends. 2020 Mar 16;14(1):69-71. doi: 10.5582/bst.2020.01020. Epub 2020 Jan 28.
PMID: 31996494
citation: Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
PMID: 32091533
citation: van Griensven J, Edwards T, de Lamballerie X, Semple MG, Gallian P, Baize S, Horby PW, Raoul H, Magassouba N, Antierens A, Lomas C, Faye O, Sall AA, Fransen K, Buyze J, Ravinetto R, Tiberghien P, Claeys Y, De Crop M, Lynen L, Bah EI, Smith PG, Delamou A, De Weggheleire A, Haba N; Ebola-Tx Consortium. Evaluation of Convalescent Plasma for Ebola Virus Disease in Guinea. N Engl J Med. 2016 Jan 7;374(1):33-42. doi: 10.1056/NEJMoa1511812.
PMID: 26735992
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
responsible party type: Principal Investigator
investigator affiliation: Grupo Mexicano para el Estudio de la Medicina Intensiva
investigator full name: Angel Augusto Perez Calatayud
investigator title: Head of division of critical care
mesh term: Pneumonia
sharing ipd: Yes
ipd description: IPD will be shared by petition.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: 3 months after completion up to five years
ipd access criteria: proposal should be directed to gmemiinv@gmails.com, to gain access, requestor will need to sign a data access agreement