Prevention, Efficacy and Safety of BCG Vaccine in COVID-19 Among Healthcare Workers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04461379|
Recruitment Status : Active, not recruiting
First Posted : July 8, 2020
Last Update Posted : November 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|BCG COVID-19 SARS-CoV2 Corona Virus Infection||Biological: BCG vaccine Other: Placebo||Phase 3|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||908 participants|
|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%
|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).|
|Official Title:||Prevention, Efficacy and Safety of BCG Vaccine in COVID-19- Randomized Clinical Trial|
|Actual Study Start Date :||July 21, 2020|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||January 1, 2021|
Experimental: BCG Vaccine
A single dose BCG vaccine intradermally 0.1 ml.
Biological: BCG vaccine
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 Name: Calmette-Guerin Bacillus vaccine
Placebo Comparator: Placebo
A single dose intradermally 0.1 ml of NaCl 0.9% solution
A single dose intradermally ((deltoid region of the right arm) 0.1 ml of NaCl 0.9% solution
- Demonstrate COVID- 19 disease incidence among Health care workers: [ Time Frame: During the 6 months study period ]
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)
- Demonstrate cumulative incidence of hospitalization for COVID-19 among Health care workers: [ Time Frame: During the 6 months study period ]Cumulative incidence of hospitalization for COVID-19
- 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 ]Incidence of specific Antibodies (IgG and IgM) against SARS-CoV-2 will be measured at 3 and 6 months
- Hospitalization of severe disease COVID-19 [ Time Frame: During the 6 months study period ]Number of participants who needed hospitalization
- Oxygen supplementation in severe disease COVID-19 [ Time Frame: During the 6 months study period ]Number of participants who Need for oxygen supplementation (nasal cannulas, masks, high flow oxygen) in hospitalized patients
- Need for intubation or non-invasive ventilation for the patient. [ Time Frame: During the 6 months study period ]Number of participants who Need for intubation or non-invasive ventilation in hospitalized patients
- Critical care admission with SARS-CoV2 [ Time Frame: During the 6 months study period ]Number of participants in Critical care admission with SARS-CoV2 in hospitalized patients
- Mortality associated to progressive pulmonary disease [ Time Frame: During the 6 months study period ]Mortality associated to progressive pulmonary disease in hospitalized patients
- 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 ]
- Calculate the incidence of COVID-19 complications [ Time Frame: During the 6 months study period ]
- Determine the mean days of hospitalization and days in intensive care unit by COIVD-19 [ Time Frame: During the 6 months study period ]
- Calculate the cost associated with in-hospital medical care [ Time Frame: During the 6 months study period ]
- 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 ]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).
- 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 ]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)
- Evaluate and determine the alteration profile in laboratory studies at the patient's hospital admission [ Time Frame: During the 6 months study period ]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.
- Registration of chronic medications [ Time Frame: During the 6 months study period ]
- Need for vasopressors [ Time Frame: During the 6 months study period ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04461379
|Hospital Universitario "José E. González"|
|Monterrey, Nuevo León, Mexico, 64460|