- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04461379
Prevention, Efficacy and Safety of BCG Vaccine in COVID-19 Among Healthcare Workers
Prevention, Efficacy and Safety of BCG Vaccine in COVID-19- Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64460
- Hospital Universitario "José E. González"
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Health workers who are working onsite in patients' areas with COVID-19
- Age > 18 years
- Negative specific IgG and IgM antibodies test result for SARS CoV-2 before the enrollment.
- Provide a signed and dated informed consent form
Exclusion Criteria:
- Age <18 years
- Positive test for specific antibodies IgG and IgM antibodies result for SARS Cov-2
- Primary or secondary immunosuppression
- Use of immunosuppression drugs, use of hydroxychloroquine, cloroquine, Azithromycin, Lopinavir/ritonavir, Ivermectin or any other drug used to treat patients COVID-19 before the enrollment.
- Chemotherapy treatment
- Presence of antibodies IgA, IgM, IgG against SARS-CoV-2
- Pregnancy or breastfeeding
- Missing informed consent form
- Fever > 38° in the previous 24 hours
- Any BCG vaccine contraindication
- History of previous allergy to the components of the vaccine
- Already part of any other trial
- Previous or active tuberculosis (TB) disease
- Another vaccine administrated 4 months before the start of the trial.
- Any underlying history of malignancy or lymphoma.
- Actual treatment with steroids
- Absence of more than 1 month from the hospital, from the study period.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BCG Vaccine
A single dose BCG vaccine intradermally 0.1 ml.
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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)
Other Names:
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Placebo Comparator: Placebo
A single dose intradermally 0.1 ml of NaCl 0.9% solution
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A single dose intradermally ((deltoid region of the right arm) 0.1 ml of NaCl 0.9% solution
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demonstrate COVID- 19 disease incidence among Health care workers:
Time Frame: During the 6 months study period
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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) |
During the 6 months study period
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Demonstrate cumulative incidence of hospitalization for COVID-19 among Health care workers:
Time Frame: During the 6 months study period
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Cumulative incidence of hospitalization for COVID-19
|
During the 6 months study period
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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
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Incidence of specific Antibodies (IgG and IgM) against SARS-CoV-2 will be measured at 3 and 6 months
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During the 6 months study period
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Hospitalization of severe disease COVID-19
Time Frame: During the 6 months study period
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Number of participants who needed hospitalization
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During the 6 months study period
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Oxygen supplementation in severe disease COVID-19
Time Frame: During the 6 months study period
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Number of participants who Need for oxygen supplementation (nasal cannulas, masks, high flow oxygen) in hospitalized patients
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During the 6 months study period
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Need for intubation or non-invasive ventilation for the patient.
Time Frame: During the 6 months study period
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Number of participants who Need for intubation or non-invasive ventilation in hospitalized patients
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During the 6 months study period
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Critical care admission with SARS-CoV2
Time Frame: During the 6 months study period
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Number of participants in Critical care admission with SARS-CoV2 in hospitalized patients
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During the 6 months study period
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Mortality associated to progressive pulmonary disease
Time Frame: During the 6 months study period
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Mortality associated to progressive pulmonary disease in hospitalized patients
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During the 6 months study period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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1 month after vaccine/placebo application
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Calculate the incidence of COVID-19 complications
Time Frame: During the 6 months study period
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During the 6 months study period
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Determine the mean days of hospitalization and days in intensive care unit by COIVD-19
Time Frame: During the 6 months study period
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During the 6 months study period
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Calculate the cost associated with in-hospital medical care
Time Frame: During the 6 months study period
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During the 6 months study period
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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
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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).
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During the 6 months study period
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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
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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)
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During the 6 months study period
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Evaluate and determine the alteration profile in laboratory studies at the patient's hospital admission
Time Frame: During the 6 months study period
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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.
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During the 6 months study period
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Registration of chronic medications
Time Frame: During the 6 months study period
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During the 6 months study period
|
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Need for vasopressors
Time Frame: During the 6 months study period
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During the 6 months study period
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Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Coronavirus Infections
- Physiological Effects of Drugs
- Immunologic Factors
- Adjuvants, Immunologic
- Vaccines
- BCG Vaccine
Other Study ID Numbers
- EN20-00011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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