<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/NCT04452812</url>
  </required_header>
  <id_info>
    <org_study_id>HUS-001/2020</org_study_id>
    <nct_id>NCT04452812</nct_id>
  </id_info>
  <brief_title>Statistical and Epidemiological Study Based on the Use of Convalescent Plasma for the Management of Patients With COVID-19</brief_title>
  <acronym>PROMETEO</acronym>
  <official_title>Pilot Clinical, Statistical and Epidemiological Study on Efficacy and Safety of Convalescent Plasma for the Management of Patients With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Autonoma de Coahuila</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Council of Science and Technology, Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad Autonoma de Coahuila</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>
      The health contingency established against the Severe Acute Respiratory Syndrome associated&#xD;
      type 2 Coronavirus (SARS-CoV-2) has promoted a race against the clock for the search on&#xD;
      treatment against the disease related with coronavirus (COVID-19). There are no current&#xD;
      approved therapeutic options against the virus, although there is a rush for the development&#xD;
      of drugs, vaccines and even the passive immunization through plasma from convalescent&#xD;
      patients. This passive immunization is made with the administration of antibodies from&#xD;
      patients that went through the infectious state of the disease and progress to clinical&#xD;
      remission.&#xD;
&#xD;
      SARS-CoV-2, and its predecessor SARS-CoV-1, have great similarities between their genes and&#xD;
      proteins; tis allow to hypothesize that the antibodies developed against SARS-CoV1 can&#xD;
      recognize the antigens of SARS-CoV-2. In this manner, the transfusion of convalescent plasma&#xD;
      to patients with the infection brings the probability on eliminating the infection, in this&#xD;
      case SARS-CoV-2. There are evidence of this phenomenon observed in previous pandemics caused&#xD;
      by SARS-CoV-1, Influenza AH1N1 and Ebola virus.&#xD;
&#xD;
      The objective of the study is to develop a therapeutic strategy based on the administration&#xD;
      of plasma from patients with COVID-19 with clinical remission to patients that are coursing&#xD;
      with the infection. The expected results hopes to establish an effective treatment and&#xD;
      satisfactory recovery of patients with COVID-19. Also, we expect to describe the respective&#xD;
      antibodies related against the SARS-CoV-2 infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The health contingency established against the Severe Acute Respiratory Syndrome associated&#xD;
      type 2 Coronavirus (SARS-CoV-2) has promoted a race against the clock for the search on&#xD;
      treatment against the disease related with coronavirus (COVID-19). There are no current&#xD;
      approved therapeutic options against the virus, although there is a rush for the development&#xD;
      of drugs, vaccines and even the passive immunization through plasma from convalescent&#xD;
      patients. This passive immunization is made with the administration of antibodies from&#xD;
      patients that went through the infectious state of the disease and progress to clinical&#xD;
      remission.&#xD;
&#xD;
      SARS-CoV-2, and its predecessor SARS-CoV-1, have great similarities between their genes and&#xD;
      proteins; tis allow to hypothesize that the antibodies developed against SARS-CoV1 can&#xD;
      recognize the antigens of SARS-CoV-2. In this manner, the transfusion of convalescent plasma&#xD;
      to patients with the infection brings the probability on eliminating the infection, in this&#xD;
      case SARS-CoV-2. There are evidence of this phenomenon observed in previous pandemics caused&#xD;
      by SARS-CoV-1, Influenza AH1N1 and Ebola virus.&#xD;
&#xD;
      The objective of the study is to develop a therapeutic strategy based on the administration&#xD;
      of plasma from patients with COVID-19 with clinical remission to patients that are coursing&#xD;
      with the infection. The expected results hopes to establish an effective treatment and&#xD;
      satisfactory recovery of patients with COVID-19. Also, we expect to describe the respective&#xD;
      antibodies related against the SARS-CoV-2 infection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 6, 2020</start_date>
  <completion_date type="Anticipated">April 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2021</primary_completion_date>
  <phase>Phase 1/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>Pilot, experimental, randomized, prospective, longitudinal, clinical study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Any cause mortality during the first 30 days of treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Side effects</measure>
    <time_frame>30 days</time_frame>
    <description>Side effects associated with the administration of convalescent plasma</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of stay in Intensive Care Unit (ICU)</measure>
    <time_frame>14 days</time_frame>
    <description>Time to discharge from the ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in hospitalization</measure>
    <time_frame>21 days</time_frame>
    <description>Time for discharge from hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of mechanical ventilation</measure>
    <time_frame>14 days</time_frame>
    <description>Number of days with ventilatory support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory biomarkers (d-dimer)</measure>
    <time_frame>21 days</time_frame>
    <description>change in D-dimer (micrograms/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory biomarkers (c-reactive protein)</measure>
    <time_frame>21 days</time_frame>
    <description>change in C-reactive protein (milligrams/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory biomarkers (lactate dehydrogenase)</measure>
    <time_frame>21 days</time_frame>
    <description>Change in LDH (UI/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory biomarkers (ferritin)</measure>
    <time_frame>21 days</time_frame>
    <description>Change in ferritin (nanograms/mL)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>COVID-19 Pneumonia</condition>
  <condition>Convalescent Plasma</condition>
  <arm_group>
    <arm_group_label>Convalescent plasma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Best available treatment + convalescent plasma&#xD;
Best available treatment: hemodynamic support, oxygen supplementation, antibiotic therapy (if required), and individualized treatment judged by the attending physician.&#xD;
Plasma will be split by aliquots of 200 ml for its storage on -60 celsius degrees until it's used. After defrosting, it will be administered on 2 200 ml separated doses on a 12 hours interval.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Best available treatment</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Best available treatment + Placebo (0.9% saline solution)&#xD;
Best available treatment: hemodynamic support, oxygen supplementation, antibiotic therapy (if required), and individualized treatment judged by the attending physician.&#xD;
Placebo will consist on 2 doses of 200 ml of 0.9% saline solution separated on a 12 hour interval.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Convalescent plasma</intervention_name>
    <description>Best available treatment + convalescent plasma&#xD;
Best available treatment: hemodynamic support, oxygen supplementation, antibiotic therapy (if required), and individualized treatment judged by the attending physician.&#xD;
Plasma will be split by aliquots of 200 ml for its storage on -60 celsius degrees until it's used. After defrosting, it will be administered on 2 200 ml separated doses on a 12 hours interval.</description>
    <arm_group_label>Best available treatment</arm_group_label>
    <arm_group_label>Convalescent plasma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (Donors):&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  At least positive for 1 q-PCR test for SARS-CoV-2&#xD;
&#xD;
          -  14 days of COVID-19 clinical remission&#xD;
&#xD;
          -  Positive serologic test for SARS-CoV-2&#xD;
&#xD;
          -  Requirements to donate according to NOM-253-SSA1-2012&#xD;
&#xD;
          -  To accept sample storing for future study&#xD;
&#xD;
        Inclusion Criteria (Receptors):&#xD;
&#xD;
          -  Signed informed consent provided by the patient, legal guardian or the health provider&#xD;
             if not available&#xD;
&#xD;
          -  Patients hospitalized in an ICU dedicated to the treatment of COVID-19 patients&#xD;
&#xD;
          -  At least positive for 1 q-PCR test for SARS-CoV-2&#xD;
&#xD;
          -  Patients with COVID-19 defined as severe or critically ill:&#xD;
&#xD;
        Severe: RF &gt; 30 bpm, oxygen saturation &lt;94%, Pa/FiO2 &lt;301, bilateral lung infiltrates that&#xD;
        extends in &gt;50% (by chest radiograph or CT scan) in 24-48 hours Critically ill: Respiratory&#xD;
        failure (PaO2 &lt;60 mmHg or SatO2 &lt;90% with FiO2 &gt;60%) and septic shock (MAP &lt;65 mmHg with&#xD;
        vasoactive requirement, lactate &gt; 2 mmol/L and SOFA score &gt;1)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
&#xD;
          -  Patients in lactation&#xD;
&#xD;
          -  Informed consent not signed&#xD;
&#xD;
          -  Patients involved in other treatment protocols&#xD;
&#xD;
          -  Patients on immunomodulatory drugs (DMARDs, monoclonal antibodies or smal molecule&#xD;
             drugs)&#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_contact>
    <last_name>Julio César Martínez Gallegos, MD, MMSc</last_name>
    <phone>8113852249</phone>
    <email>juliomartinez.18@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitario &quot;Dr. Gonzalo Valdés Valdés&quot;</name>
      <address>
        <city>Saltillo</city>
        <state>Coahuila</state>
        <zip>25000</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <contact>
      <last_name>Julio César Martínez Gallegos, MD, MSc</last_name>
      <phone>8113852249</phone>
      <email>juliomartinez.18@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Convalescent plasma</keyword>
  <keyword>plasmapheresis</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>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
  </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/NCT04452812
org study id: HUS-001/2020
nct id: NCT04452812
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The health contingency established against the Severe Acute Respiratory Syndrome associated
      type 2 Coronavirus (SARS-CoV-2) has promoted a race against the clock for the search on
      treatment against the disease related with coronavirus (COVID-19). There are no current
      approved therapeutic options against the virus, although there is a rush for the development
      of drugs, vaccines and even the passive immunization through plasma from convalescent
      patients. This passive immunization is made with the administration of antibodies from
      patients that went through the infectious state of the disease and progress to clinical
      remission.

      SARS-CoV-2, and its predecessor SARS-CoV-1, have great similarities between their genes and
      proteins; tis allow to hypothesize that the antibodies developed against SARS-CoV1 can
      recognize the antigens of SARS-CoV-2. In this manner, the transfusion of convalescent plasma
      to patients with the infection brings the probability on eliminating the infection, in this
      case SARS-CoV-2. There are evidence of this phenomenon observed in previous pandemics caused
      by SARS-CoV-1, Influenza AH1N1 and Ebola virus.

      The objective of the study is to develop a therapeutic strategy based on the administration
      of plasma from patients with COVID-19 with clinical remission to patients that are coursing
      with the infection. The expected results hopes to establish an effective treatment and
      satisfactory recovery of patients with COVID-19. Also, we expect to describe the respective
      antibodies related against the SARS-CoV-2 infection.
The health contingency established against the Severe Acute Respiratory Syndrome associated
      type 2 Coronavirus (SARS-CoV-2) has promoted a race against the clock for the search on
      treatment against the disease related with coronavirus (COVID-19). There are no current
      approved therapeutic options against the virus, although there is a rush for the development
      of drugs, vaccines and even the passive immunization through plasma from convalescent
      patients. This passive immunization is made with the administration of antibodies from
      patients that went through the infectious state of the disease and progress to clinical
      remission.

      SARS-CoV-2, and its predecessor SARS-CoV-1, have great similarities between their genes and
      proteins; tis allow to hypothesize that the antibodies developed against SARS-CoV1 can
      recognize the antigens of SARS-CoV-2. In this manner, the transfusion of convalescent plasma
      to patients with the infection brings the probability on eliminating the infection, in this
      case SARS-CoV-2. There are evidence of this phenomenon observed in previous pandemics caused
      by SARS-CoV-1, Influenza AH1N1 and Ebola virus.

      The objective of the study is to develop a therapeutic strategy based on the administration
      of plasma from patients with COVID-19 with clinical remission to patients that are coursing
      with the infection. The expected results hopes to establish an effective treatment and
      satisfactory recovery of patients with COVID-19. Also, we expect to describe the respective
      antibodies related against the SARS-CoV-2 infection.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Pilot, experimental, randomized, prospective, longitudinal, clinical study
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: All-cause mortality
time frame: 30 days
description: Any cause mortality during the first 30 days of treatment
measure: Side effects
time frame: 30 days
description: Side effects associated with the administration of convalescent plasma
measure: Length of stay in Intensive Care Unit (ICU)
time frame: 14 days
description: Time to discharge from the ICU
measure: Length of stay in hospitalization
time frame: 21 days
description: Time for discharge from hospital
measure: Days of mechanical ventilation
time frame: 14 days
description: Number of days with ventilatory support
measure: Inflammatory biomarkers (d-dimer)
time frame: 21 days
description: change in D-dimer (micrograms/L)
measure: Inflammatory biomarkers (c-reactive protein)
time frame: 21 days
description: change in C-reactive protein (milligrams/dL)
measure: Inflammatory biomarkers (lactate dehydrogenase)
time frame: 21 days
description: Change in LDH (UI/L)
measure: Inflammatory biomarkers (ferritin)
time frame: 21 days
description: Change in ferritin (nanograms/mL)
arm group label: Convalescent plasma
arm group type: Experimental
description: Best available treatment + convalescent plasma
Best available treatment: hemodynamic support, oxygen supplementation, antibiotic therapy (if required), and individualized treatment judged by the attending physician.
Plasma will be split by aliquots of 200 ml for its storage on -60 celsius degrees until it's used. After defrosting, it will be administered on 2 200 ml separated doses on a 12 hours interval.
arm group label: Best available treatment
arm group type: Placebo Comparator
description: Best available treatment + Placebo (0.9% saline solution)
Best available treatment: hemodynamic support, oxygen supplementation, antibiotic therapy (if required), and individualized treatment judged by the attending physician.
Placebo will consist on 2 doses of 200 ml of 0.9% saline solution separated on a 12 hour interval.
intervention type: Biological
intervention name: Convalescent plasma
description: Best available treatment + convalescent plasma
Best available treatment: hemodynamic support, oxygen supplementation, antibiotic therapy (if required), and individualized treatment judged by the attending physician.
Plasma will be split by aliquots of 200 ml for its storage on -60 celsius degrees until it's used. After defrosting, it will be administered on 2 200 ml separated doses on a 12 hours interval.
arm group label: Best available treatment
arm group label: Convalescent plasma
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julio César Martínez Gallegos, MD, MMSc
phone: 8113852249
email: juliomartinez.18@hotmail.com
facility: 
contact: 
country: Mexico
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Yes
ipd info type: Study Protocol