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Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to COVID-19 Infection in Healthcare Personnel (Bacmune)

Primary Purpose

Covid19

Status
Withdrawn
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
BACMUNE (MV130)
Placebo
Sponsored by
Inmunotek S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Health personnel who are or have been in contact with patients with disease due to SARS-COV-2 infection within the last 14 days before randomization.
  • Negative result for test against COVID-19.
  • Subjects who have given informed consent.
  • Men or women aged between 18 and 65 years, both included.
  • Subjects who have a smartphone where they can load an APP for monitoring the symptoms.

Exclusion Criteria:

  • Subjects who are participating in another clinical trial.
  • Subjects who are unable to offer cooperation and/or have serious psychiatric disorders.
  • Subjects who are allergic to any of the compounds included into MV130.
  • Subjects who present contraindications to any of the components of BACMUNE (MV130).
  • Subjects who are not able to comply with the dosage regimen.
  • Subjects with immunodeficiencies.
  • Subjects with malignancy involving the bone marrow or lymphoid systems.
  • Pregnant or suspected pregnant women and breastfeeding women.
  • Subjects in medical treatment that affects the response of the immune system. It includes corticosteroids (equal to or more than 20 mg for more than 2 weeks), immunosuppressants, biological agents (such as anti TNF-alpha monoclonal antibodies, etc.).
  • Subjects with HIV.
  • Subjects under treatment with metformin.
  • Subjects treated with Sertraline.
  • Subjects treated with statins.

Sites / Locations

  • Instituto Nacional de Enfermedades Respiratorias (INER)
  • Hospital General de Pachuca
  • Hospital de Ciudad Valles

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bacmune (MV130)

Placebo

Arm Description

Subject included in the active group will receive Bacmune. The dose consists on 2 spray puff every 12 hours for 45 days.

Subject included in the placebo group will receive placebo. The dose consists on 2 spray puff every 12 hours for 45 days.

Outcomes

Primary Outcome Measures

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)
Severity of COVID-19
Incidence of severe COVID-19, defined by CURB > 2 and/or death

Secondary Outcome Measures

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
Subjects with symptoms
Rate of subjects with any symptoms, whether confirmed, probable or suspected, according to the WHO definition
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
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.
Elapsed time until hospitalization
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
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
Elapsed time until the first symptoms of COVID-19 appears to death from any cause not related to COVID-19.

Full Information

First Posted
June 26, 2020
Last Updated
October 29, 2020
Sponsor
Inmunotek S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT04452643
Brief Title
Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to COVID-19 Infection in Healthcare Personnel
Acronym
Bacmune
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Not authorized by Cofepris (Mexico Competent Regulatory Authority)
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inmunotek S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Double blind placebo control
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double blind placebo control
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bacmune (MV130)
Arm Type
Active Comparator
Arm Description
Subject included in the active group will receive Bacmune. The dose consists on 2 spray puff every 12 hours for 45 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subject included in the placebo group will receive placebo. The dose consists on 2 spray puff every 12 hours for 45 days.
Intervention Type
Biological
Intervention Name(s)
BACMUNE (MV130)
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo is a solution on sodium chloride at 0.9%
Primary Outcome Measure Information:
Title
Incidence of subjects with COVID-19
Description
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
Title
Severity of COVID-19
Description
Incidence of severe COVID-19, defined by CURB > 2 and/or death
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Seroconversion to SARS-CoV-2
Description
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
Title
Subjects with symptoms
Description
Rate of subjects with any symptoms, whether confirmed, probable or suspected, according to the WHO definition
Time Frame
60 days
Title
Hospital admission due to COVID-19
Description
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
Title
Admission to an intensive care unit due to COVID-19
Description
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
Title
Elapsed time until hospitalization
Description
Elapsed time until the first symptoms of COVID-19 appears to hospitalization due to COVID-19.
Time Frame
60 days
Title
Elapsed time until admission into an care unit for COVID-19
Description
Elapsed time until the first symptoms of COVID-19 appears to admission into an intensive care unit pro COVID-19.
Time Frame
60 days
Title
Elapsed time until death not related to COVID-19
Description
Elapsed time until the first symptoms of COVID-19 appears to death from any cause not related to COVID-19.
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Health personnel who are or have been in contact with patients with disease due to SARS-COV-2 infection within the last 14 days before randomization. Negative result for test against COVID-19. Subjects who have given informed consent. Men or women aged between 18 and 65 years, both included. Subjects who have a smartphone where they can load an APP for monitoring the symptoms. Exclusion Criteria: Subjects who are participating in another clinical trial. Subjects who are unable to offer cooperation and/or have serious psychiatric disorders. Subjects who are allergic to any of the compounds included into MV130. Subjects who present contraindications to any of the components of BACMUNE (MV130). Subjects who are not able to comply with the dosage regimen. Subjects with immunodeficiencies. Subjects with malignancy involving the bone marrow or lymphoid systems. Pregnant or suspected pregnant women and breastfeeding women. Subjects in medical treatment that affects the response of the immune system. It includes corticosteroids (equal to or more than 20 mg for more than 2 weeks), immunosuppressants, biological agents (such as anti TNF-alpha monoclonal antibodies, etc.). Subjects with HIV. Subjects under treatment with metformin. Subjects treated with Sertraline. Subjects treated with statins.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosaura Esperanza Benitez Pérez
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Felipe Monrroy López
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Blanca Nohemí Zamora Mendoza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Enfermedades Respiratorias (INER)
City
Ciudad de México
ZIP/Postal Code
Ciudad de México
Country
Mexico
Facility Name
Hospital General de Pachuca
City
Pachuca de Soto
ZIP/Postal Code
42070
Country
Mexico
Facility Name
Hospital de Ciudad Valles
City
San Luis Potosí
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to COVID-19 Infection in Healthcare Personnel

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