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

NCT ID: NCT04452643

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-31

Study Completion Date

2021-12-31

Brief Summary

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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

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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

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind placebo control
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Double blind placebo control

Study Groups

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Bacmune (MV130)

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

Group Type ACTIVE_COMPARATOR

BACMUNE (MV130)

Intervention Type BIOLOGICAL

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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo is a solution on sodium chloride at 0.9%

Interventions

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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)

Intervention Type BIOLOGICAL

Placebo

Placebo is a solution on sodium chloride at 0.9%

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inmunotek S.L.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rosaura Esperanza Benitez Pérez

Role: PRINCIPAL_INVESTIGATOR

Felipe Monrroy López

Role: PRINCIPAL_INVESTIGATOR

Blanca Nohemí Zamora Mendoza

Role: PRINCIPAL_INVESTIGATOR

Locations

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Instituto Nacional de Enfermedades Respiratorias (INER)

Mexico City, , Mexico

Site Status

Hospital General de Pachuca

Pachuca, , Mexico

Site Status

Hospital de Ciudad Valles

San Luis Potosí City, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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MV130-SLG-037

Identifier Type: -

Identifier Source: org_study_id