Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to COVID-19 Infection in Healthcare Personnel (Bacmune)
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|ClinicalTrials.gov Identifier: NCT04452643|
Recruitment Status : Withdrawn (Not authorized by Cofepris (Mexico Competent Regulatory Authority))
First Posted : June 30, 2020
Last Update Posted : November 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Biological: BACMUNE (MV130) Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double blind placebo control|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Double blind placebo control|
|Official Title:||Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial on the Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to SARS-CoV-2 Infection in Healthcare Personnel|
|Estimated Study Start Date :||October 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Bacmune (MV130)
Subject included in the active group will receive Bacmune. The dose consists on 2 spray puff every 12 hours for 45 days.
Biological: BACMUNE (MV130)
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 Comparator: Placebo
Subject included in the placebo group will receive placebo. The dose consists on 2 spray puff every 12 hours for 45 days.
Placebo is a solution on sodium chloride at 0.9%
- Incidence of subjects with COVID-19 [ Time Frame: 60 days ]
Incidence of subjects with COVID-19, defined by the presence of:
- 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)
- Severity of COVID-19 [ Time Frame: 60 days ]Incidence of severe COVID-19, defined by CURB > 2 and/or death
- Seroconversion to SARS-CoV-2 [ Time Frame: 60 days ]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
- Subjects with symptoms [ Time Frame: 60 days ]Rate of subjects with any symptoms, whether confirmed, probable or suspected, according to the WHO definition
- Hospital admission due to COVID-19 [ Time Frame: 60 days ]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
- Admission to an intensive care unit due to COVID-19 [ Time Frame: 60 days ]
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.
- Elapsed time until hospitalization [ Time Frame: 60 days ]Elapsed time until the first symptoms of COVID-19 appears to hospitalization due to COVID-19.
- Elapsed time until admission into an care unit for COVID-19 [ Time Frame: 60 days ]Elapsed time until the first symptoms of COVID-19 appears to admission into an intensive care unit pro COVID-19.
- Elapsed time until death not related to COVID-19 [ Time Frame: 60 days ]Elapsed time until the first symptoms of COVID-19 appears to death from any cause not related to COVID-19.
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): NCT04452643
|Instituto Nacional de Enfermedades Respiratorias (INER)|
|Ciudad de México, Mexico, Ciudad de México|
|Hospital General de Pachuca|
|Pachuca de Soto, Mexico, 42070|
|Hospital de Ciudad Valles|
|San Luis Potosí, Mexico|
|Principal Investigator:||Rosaura Esperanza Benitez Pérez|
|Principal Investigator:||Felipe Monrroy López|
|Principal Investigator:||Blanca Nohemí Zamora Mendoza|