The purpose of this trial is to assess the effect of immunotherapy with the bacterial preparation MV130 on the spread and course of SARS-CoV-2 infection in highly exposed subjets, as is the case with healthcare personnel.
This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy of BACMUNE (MV130) in the prevention of disease due to SARS-VoC-2 infection in healthcare personnel
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
BACMUNE (MV130) is a bacterial preparation that contains a mixture of Gram + and Gram - inactivated bacteria at the concentration of 300 FTU / mL (approx. 10\^9 bacteria / mL)
Placebo is a solution on sodium chloride at 0.9%
Instituto Nacional de Enfermedades Respiratorias (INER)
Mexico City, Mexico
Hospital General de Pachuca
Pachuca, Mexico
Hospital de Ciudad Valles
San Luis Potosí City, Mexico
Incidence of subjects with COVID-19
Incidence of subjects with COVID-19, defined by the presence of: * Fever * Any of the respiratory signs and/or symptoms: cough, dyspnea, respiratory failure, runny nose/nasal obstruction. * Positive test for SARS-COV-2 (PCR o serology)
Time frame: 60 days
Severity of COVID-19
Incidence of severe COVID-19, defined by CURB \> 2 and/or death
Time frame: 60 days
Seroconversion to SARS-CoV-2
Rate of subjects with seroconversion to SARS-CoV-2 (negative serology at the beginning of the study and positive at the end of the study
Time frame: 60 days
Subjects with symptoms
Rate of subjects with any symptoms, whether confirmed, probable or suspected, according to the WHO definition
Time frame: 60 days
Hospital admission due to COVID-19
The effect of the treatment on the severity of the disease will be measured based on the rate of subjects requiring hospital admission for COVID-19
Time frame: 60 days
Admission to an intensive care unit due to COVID-19
The effect of the treatment on the severity of the disease will be measured based on the rate of subjects who require admission to an intensive care unit for COVID-19 • Time from confirmation of SARS-CoV-2 infection to the appearance of symptoms.
Time frame: 60 days
Elapsed time until hospitalization
Elapsed time until the first symptoms of COVID-19 appears to hospitalization due to COVID-19.
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Time frame: 60 days
Elapsed time until admission into an care unit for COVID-19
Elapsed time until the first symptoms of COVID-19 appears to admission into an intensive care unit pro COVID-19.
Time frame: 60 days
Elapsed time until death not related to COVID-19
Elapsed time until the first symptoms of COVID-19 appears to death from any cause not related to COVID-19.
Time frame: 60 days