<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/NCT04461379</url>
  </required_header>
  <id_info>
    <org_study_id>EN20-00011</org_study_id>
    <nct_id>NCT04461379</nct_id>
  </id_info>
  <brief_title>Prevention, Efficacy and Safety of BCG Vaccine in COVID-19 Among Healthcare Workers</brief_title>
  <official_title>Prevention, Efficacy and Safety of BCG Vaccine in COVID-19- Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario Dr. Jose E. Gonzalez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitario Dr. Jose E. Gonzalez</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      In Mexico the total number of confirmed cases of COVID-19 is 232, 000 and 28,510 deaths.&#xD;
      Health workers are at high risk of COVID-19 infection. Their absence from work dramatically&#xD;
      limits the ability to contain the disease. There is currently no vaccine to prevent the&#xD;
      disease. Since the introduction to the vaccination schedule of the Bacillus Calmette-Guerin&#xD;
      (BCG) live attenuated vaccine directed towards tuberculosis prevention, a decrease in infant&#xD;
      mortality has been reported, not related only to tuberculosis. BCG vaccine has been&#xD;
      hypothesized to have a non-specific role towards other unrelated pathogens such as viruses&#xD;
      that cause airway disease, with reduced morbidity and mortality. In murine as well as in&#xD;
      human models it has been shown to decrease the incidence of acute respiratory influenza&#xD;
      infections. Likewise, in countries with a high endemicity for tuberculosis, the BCG vaccine&#xD;
      reduces the incidence of respiratory infections by up to 80% . In healthy subjects, the BCG&#xD;
      vaccine increases the production of proinflammatory cytokines in monocytes. Likewise, it&#xD;
      increases the epigenetic response, causing an increase in the transcription of genes&#xD;
      important in the antimicrobial response, as well as an improvement in cellular function. This&#xD;
      is the first national clinical trial to evaluate prospectively the effect that the BCG&#xD;
      vaccine offers towards the prevention and reduction of severity in cases of COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study design is a randomized, double-blinded, placebo-controlled clinical trial.&#xD;
&#xD;
      Age stratified randomization (&lt;45 years and&gt; 45 years) was performed using permuted blocks&#xD;
      with allocation concealment.&#xD;
&#xD;
      The sample size is 908 patients. 454 patients in each stratum (227 with placebo and 227 with&#xD;
      BCG vaccine).&#xD;
&#xD;
      Eligible participants will be healthcare professionals over 18 years of age who are in&#xD;
      contact with patients with COVID-19, with negative IgG and IgM antibodies results for&#xD;
      SARS-CoV-2 prior to their inclusion and sign the informed consent. After signing the informed&#xD;
      consent, the participants will be randomized 1:1 to the intervention group (BCG vaccine) or&#xD;
      control (placebo), a medical history will be performed, and a blood plasma sample will be&#xD;
      obtained to determine specific antibodies against SARS-CoV-2.&#xD;
&#xD;
      The patients will be followed up for 6 months after the application of the vaccine, they will&#xD;
      be contacted by phone every two weeks in order to identify the adverse effects of the vaccine&#xD;
      (30 days after the application) as well as to identify symptoms of COVID-19, in addition,&#xD;
      follow-up visits will be carried out at the third and sixth months, in each of these visits a&#xD;
      blood plasma sample will be obtained and IgG and IgM antibodies will be measured.&#xD;
&#xD;
      Statistical Analysis Type: By intention to treatment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 21, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</primary_completion_date>
  <phase>Phase 3</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>A randomized double-blinded clinical trial, using computer software, participants will be allocated between two groups:&#xD;
Intervention: BCG vaccine intradermally 0.1 ml, equivalent to 0.075 mg of attenuated Mycobacterium bovis. (Tokio 172 strain). The application technique is based on the National Vaccination Manual version 2017.&#xD;
Comparator: Placebo, intradermally 0.1 ml of NaCl 0.9%</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Participants, researchers (including members of the research team that will assess outcomes), and treating physicians or health personnel (should the patient require in-hospital management) will be blinded to the treatment group to which the patients were randomized. Only the personnel who apply the vaccine will not be blinded to the treatment group to which the patients were randomized (this personnel will not have any further contact with the patients or provide any other type of patient care).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Demonstrate COVID- 19 disease incidence among Health care workers:</measure>
    <time_frame>During the 6 months study period</time_frame>
    <description>Cumulative incidence of infection in 6 months:&#xD;
disease defined as positive SARS-Cov-2 test (serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Demonstrate cumulative incidence of hospitalization for COVID-19 among Health care workers:</measure>
    <time_frame>During the 6 months study period</time_frame>
    <description>Cumulative incidence of hospitalization for COVID-19</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Demonstrate the Incidence of specific Antibodies against SARS-CoV-2 at 3 and 6 months in health care workers</measure>
    <time_frame>During the 6 months study period</time_frame>
    <description>Incidence of specific Antibodies (IgG and IgM) against SARS-CoV-2 will be measured at 3 and 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospitalization of severe disease COVID-19</measure>
    <time_frame>During the 6 months study period</time_frame>
    <description>Number of participants who needed hospitalization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxygen supplementation in severe disease COVID-19</measure>
    <time_frame>During the 6 months study period</time_frame>
    <description>Number of participants who Need for oxygen supplementation (nasal cannulas, masks, high flow oxygen) in hospitalized patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Need for intubation or non-invasive ventilation for the patient.</measure>
    <time_frame>During the 6 months study period</time_frame>
    <description>Number of participants who Need for intubation or non-invasive ventilation in hospitalized patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Critical care admission with SARS-CoV2</measure>
    <time_frame>During the 6 months study period</time_frame>
    <description>Number of participants in Critical care admission with SARS-CoV2 in hospitalized patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality associated to progressive pulmonary disease</measure>
    <time_frame>During the 6 months study period</time_frame>
    <description>Mortality associated to progressive pulmonary disease in hospitalized patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the safety of the vaccine by measuring the incidence rates of local and systemic adverse effects that occur after one month its application.</measure>
    <time_frame>1 month after vaccine/placebo application</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculate the incidence of COVID-19 complications</measure>
    <time_frame>During the 6 months study period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine the mean days of hospitalization and days in intensive care unit by COIVD-19</measure>
    <time_frame>During the 6 months study period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculate the cost associated with in-hospital medical care</measure>
    <time_frame>During the 6 months study period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine the scores of the Clinical Prediction Rules associated with mortality using Sequential Organ Failure Assessment (SOFA score) at the patient's hospital admission:</measure>
    <time_frame>During the 6 months study period</time_frame>
    <description>SOFA score: PaO2/FIO2 (mm Hg), SaO2/FIO2, Platelets (×10³/µL), Bilirubin (mg/dL), Hypotension, Glasgow Coma Score and Creatinine (mg/dL) or urine output (mL/d).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine the scores of the Clinical Prediction Rules associated with mortality using Acute Physiology and Chronic Health disease Classification System (APACHE) at the patient's hospital admission:</measure>
    <time_frame>During the 6 months study period</time_frame>
    <description>APACHE: History of severe organ failure or immunocompromise Heart Failure Class IV, cirrhosis, chronic lung disease, or dialysis-dependent, Age, Temperature (C°), Mean arterial pressure (mmHg), pH, Sodium (mEq/L), Potassium (mEq/L), Creatinine (mg/dL), Hematocrit (%), WBC (x 109/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate and determine the alteration profile in laboratory studies at the patient's hospital admission</measure>
    <time_frame>During the 6 months study period</time_frame>
    <description>CPR, ESR, Ferritin, D-dimer, LDH,Troponins, Procalcitonin, Interleukin-6, Hemoglobin, Hematocrit, Erythrocytes, Leukocytes, MCV, HCM, MCHC, Lymphocytes, Monocytes, Eosinophils, Basophils, Platelets, Glucose, Urea, Creatinine, BUN, Sodium, Potassium, Chlorine, Calcium, Serum albumin, Direct bilirubin, Indirect bilirubin, Alkaline phosphatase, AST, ALT, bleeding time, Prothrombin Time, Activated partial thromboplastin time, Arterial / Venous Blood Gasometry, pH, pCO2, HCO3, pO2, SaO2%, Lactate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Registration of chronic medications</measure>
    <time_frame>During the 6 months study period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for vasopressors</measure>
    <time_frame>During the 6 months study period</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">908</enrollment>
  <condition>BCG</condition>
  <condition>COVID-19</condition>
  <condition>SARS-CoV2</condition>
  <condition>Corona Virus Infection</condition>
  <arm_group>
    <arm_group_label>BCG Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose BCG vaccine intradermally 0.1 ml.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A single dose intradermally 0.1 ml of NaCl 0.9% solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BCG vaccine</intervention_name>
    <description>A single dose BCG vaccine intradermally (deltoid region of the right arm) 0.1 ml, equivalent to 0.075 mg of attenuated Mycobacterium bovis . (Tokio 172 strain)</description>
    <arm_group_label>BCG Vaccine</arm_group_label>
    <other_name>Calmette-Guerin Bacillus vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>A single dose intradermally ((deltoid region of the right arm) 0.1 ml of NaCl 0.9% solution</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Health workers who are working onsite in patients' areas with COVID-19&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Negative specific IgG and IgM antibodies test result for SARS CoV-2 before the&#xD;
             enrollment.&#xD;
&#xD;
          -  Provide a signed and dated informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Positive test for specific antibodies IgG and IgM antibodies result for SARS Cov-2&#xD;
&#xD;
          -  Primary or secondary immunosuppression&#xD;
&#xD;
          -  Use of immunosuppression drugs, use of hydroxychloroquine, cloroquine, Azithromycin,&#xD;
             Lopinavir/ritonavir, Ivermectin or any other drug used to treat patients COVID-19&#xD;
             before the enrollment.&#xD;
&#xD;
          -  Chemotherapy treatment&#xD;
&#xD;
          -  Presence of antibodies IgA, IgM, IgG against SARS-CoV-2&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Missing informed consent form&#xD;
&#xD;
          -  Fever &gt; 38° in the previous 24 hours&#xD;
&#xD;
          -  Any BCG vaccine contraindication&#xD;
&#xD;
          -  History of previous allergy to the components of the vaccine&#xD;
&#xD;
          -  Already part of any other trial&#xD;
&#xD;
          -  Previous or active tuberculosis (TB) disease&#xD;
&#xD;
          -  Another vaccine administrated 4 months before the start of the trial.&#xD;
&#xD;
          -  Any underlying history of malignancy or lymphoma.&#xD;
&#xD;
          -  Actual treatment with steroids&#xD;
&#xD;
          -  Absence of more than 1 month from the hospital, from the study period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Universitario &quot;José E. González&quot;</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo León</state>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <link>
    <url>https://www.who.int/emergencies/diseases/novel-coronavirus-2019</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://www.nature.com/articles/s41585-020-0325-9</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/32393823</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>https://www.gob.mx/salud%7Ccensia/documentos/manual-de-vacunacion-edicion-2017</url>
    <description>Related Info</description>
  </link>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>November 12, 2020</last_update_submitted>
  <last_update_submitted_qc>November 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario Dr. Jose E. Gonzalez</investigator_affiliation>
    <investigator_full_name>René Rodríguez-Gutiérrez</investigator_full_name>
    <investigator_title>Professor Endocrinology Division, Facultad de Medicina</investigator_title>
  </responsible_party>
  <keyword>Healthcare workers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
    <mesh_term>BCG Vaccine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04461379
org study id: EN20-00011
nct id: NCT04461379
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In Mexico the total number of confirmed cases of COVID-19 is 232, 000 and 28,510 deaths.
      Health workers are at high risk of COVID-19 infection. Their absence from work dramatically
      limits the ability to contain the disease. There is currently no vaccine to prevent the
      disease. Since the introduction to the vaccination schedule of the Bacillus Calmette-Guerin
      (BCG) live attenuated vaccine directed towards tuberculosis prevention, a decrease in infant
      mortality has been reported, not related only to tuberculosis. BCG vaccine has been
      hypothesized to have a non-specific role towards other unrelated pathogens such as viruses
      that cause airway disease, with reduced morbidity and mortality. In murine as well as in
      human models it has been shown to decrease the incidence of acute respiratory influenza
      infections. Likewise, in countries with a high endemicity for tuberculosis, the BCG vaccine
      reduces the incidence of respiratory infections by up to 80% . In healthy subjects, the BCG
      vaccine increases the production of proinflammatory cytokines in monocytes. Likewise, it
      increases the epigenetic response, causing an increase in the transcription of genes
      important in the antimicrobial response, as well as an improvement in cellular function. This
      is the first national clinical trial to evaluate prospectively the effect that the BCG
      vaccine offers towards the prevention and reduction of severity in cases of COVID-19.
The study design is a randomized, double-blinded, placebo-controlled clinical trial.

      Age stratified randomization (<45 years and> 45 years) was performed using permuted blocks
      with allocation concealment.

      The sample size is 908 patients. 454 patients in each stratum (227 with placebo and 227 with
      BCG vaccine).

      Eligible participants will be healthcare professionals over 18 years of age who are in
      contact with patients with COVID-19, with negative IgG and IgM antibodies results for
      SARS-CoV-2 prior to their inclusion and sign the informed consent. After signing the informed
      consent, the participants will be randomized 1:1 to the intervention group (BCG vaccine) or
      control (placebo), a medical history will be performed, and a blood plasma sample will be
      obtained to determine specific antibodies against SARS-CoV-2.

      The patients will be followed up for 6 months after the application of the vaccine, they will
      be contacted by phone every two weeks in order to identify the adverse effects of the vaccine
      (30 days after the application) as well as to identify symptoms of COVID-19, in addition,
      follow-up visits will be carried out at the third and sixth months, in each of these visits a
      blood plasma sample will be obtained and IgG and IgM antibodies will be measured.

      Statistical Analysis Type: By intention to treatment
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomized double-blinded clinical trial, using computer software, participants will be allocated between two groups:
Intervention: BCG vaccine intradermally 0.1 ml, equivalent to 0.075 mg of attenuated Mycobacterium bovis. (Tokio 172 strain). The application technique is based on the National Vaccination Manual version 2017.
Comparator: Placebo, intradermally 0.1 ml of NaCl 0.9%
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Participants, researchers (including members of the research team that will assess outcomes), and treating physicians or health personnel (should the patient require in-hospital management) will be blinded to the treatment group to which the patients were randomized. Only the personnel who apply the vaccine will not be blinded to the treatment group to which the patients were randomized (this personnel will not have any further contact with the patients or provide any other type of patient care).
measure: Demonstrate COVID- 19 disease incidence among Health care workers:
time frame: During the 6 months study period
description: Cumulative incidence of infection in 6 months:
disease defined as positive SARS-Cov-2 test (serology), plus fever (using self-reported questionnaire), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (using self-reported questionnaire)
measure: Demonstrate cumulative incidence of hospitalization for COVID-19 among Health care workers:
time frame: During the 6 months study period
description: Cumulative incidence of hospitalization for COVID-19
measure: Demonstrate the Incidence of specific Antibodies against SARS-CoV-2 at 3 and 6 months in health care workers
time frame: During the 6 months study period
description: Incidence of specific Antibodies (IgG and IgM) against SARS-CoV-2 will be measured at 3 and 6 months
measure: Hospitalization of severe disease COVID-19
time frame: During the 6 months study period
description: Number of participants who needed hospitalization
measure: Oxygen supplementation in severe disease COVID-19
time frame: During the 6 months study period
description: Number of participants who Need for oxygen supplementation (nasal cannulas, masks, high flow oxygen) in hospitalized patients
measure: Need for intubation or non-invasive ventilation for the patient.
time frame: During the 6 months study period
description: Number of participants who Need for intubation or non-invasive ventilation in hospitalized patients
measure: Critical care admission with SARS-CoV2
time frame: During the 6 months study period
description: Number of participants in Critical care admission with SARS-CoV2 in hospitalized patients
measure: Mortality associated to progressive pulmonary disease
time frame: During the 6 months study period
description: Mortality associated to progressive pulmonary disease in hospitalized patients
measure: Evaluate the safety of the vaccine by measuring the incidence rates of local and systemic adverse effects that occur after one month its application.
time frame: 1 month after vaccine/placebo application
measure: Calculate the incidence of COVID-19 complications
time frame: During the 6 months study period
measure: Determine the mean days of hospitalization and days in intensive care unit by COIVD-19
time frame: During the 6 months study period
measure: Calculate the cost associated with in-hospital medical care
time frame: During the 6 months study period
measure: Determine the scores of the Clinical Prediction Rules associated with mortality using Sequential Organ Failure Assessment (SOFA score) at the patient's hospital admission:
time frame: During the 6 months study period
description: SOFA score: PaO2/FIO2 (mm Hg), SaO2/FIO2, Platelets (×10³/µL), Bilirubin (mg/dL), Hypotension, Glasgow Coma Score and Creatinine (mg/dL) or urine output (mL/d).
measure: Determine the scores of the Clinical Prediction Rules associated with mortality using Acute Physiology and Chronic Health disease Classification System (APACHE) at the patient's hospital admission:
time frame: During the 6 months study period
description: APACHE: History of severe organ failure or immunocompromise Heart Failure Class IV, cirrhosis, chronic lung disease, or dialysis-dependent, Age, Temperature (C°), Mean arterial pressure (mmHg), pH, Sodium (mEq/L), Potassium (mEq/L), Creatinine (mg/dL), Hematocrit (%), WBC (x 109/L)
measure: Evaluate and determine the alteration profile in laboratory studies at the patient's hospital admission
time frame: During the 6 months study period
description: CPR, ESR, Ferritin, D-dimer, LDH,Troponins, Procalcitonin, Interleukin-6, Hemoglobin, Hematocrit, Erythrocytes, Leukocytes, MCV, HCM, MCHC, Lymphocytes, Monocytes, Eosinophils, Basophils, Platelets, Glucose, Urea, Creatinine, BUN, Sodium, Potassium, Chlorine, Calcium, Serum albumin, Direct bilirubin, Indirect bilirubin, Alkaline phosphatase, AST, ALT, bleeding time, Prothrombin Time, Activated partial thromboplastin time, Arterial / Venous Blood Gasometry, pH, pCO2, HCO3, pO2, SaO2%, Lactate.
measure: Registration of chronic medications
time frame: During the 6 months study period
measure: Need for vasopressors
time frame: During the 6 months study period
arm group label: BCG Vaccine
arm group type: Experimental
description: A single dose BCG vaccine intradermally 0.1 ml.
arm group label: Placebo
arm group type: Placebo Comparator
description: A single dose intradermally 0.1 ml of NaCl 0.9% solution
intervention type: Biological
intervention name: BCG vaccine
description: A single dose BCG vaccine intradermally (deltoid region of the right arm) 0.1 ml, equivalent to 0.075 mg of attenuated Mycobacterium bovis . (Tokio 172 strain)
arm group label: BCG Vaccine
other name: Calmette-Guerin Bacillus vaccine
intervention type: Other
intervention name: Placebo
description: A single dose intradermally ((deltoid region of the right arm) 0.1 ml of NaCl 0.9% solution
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Mexico
url: https://www.who.int/emergencies/diseases/novel-coronavirus-2019
description: Related Info
url: http://www.nature.com/articles/s41585-020-0325-9
description: Related Info
url: http://www.ncbi.nlm.nih.gov/pubmed/32393823
description: Related Info
url: https://www.gob.mx/salud%7Ccensia/documentos/manual-de-vacunacion-edicion-2017
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario Dr. Jose E. Gonzalez
investigator full name: René Rodríguez-Gutiérrez
investigator title: Professor Endocrinology Division, Facultad de Medicina
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Vaccines
mesh term: BCG Vaccine
sharing ipd: No