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

NCT04452643 | Withdrawn Phase 3

• 1 other identifier: MV130-SLG-037
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

• 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)

  60 days

• Severity of COVID-19

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

  60 days

Secondary Outcomes (7)

• Seroconversion to SARS-CoV-2

  60 days

• Subjects with symptoms

  60 days

• Hospital admission due to COVID-19

  60 days

• Admission to an intensive care unit due to COVID-19

  60 days

• Elapsed time until hospitalization

  60 days

Study Arms (2)

Bacmune (MV130)

ACTIVE COMPARATOR

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)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

BACMUNE (MV130) 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)

Bacmune (MV130)

Placebo OTHER

Placebo is a solution on sodium chloride at 0.9%

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inmunotek S.L.: lead

Study Sites (3)

Instituto Nacional de Enfermedades Respiratorias (INER)

Mexico City, Ciudad de México, Mexico

Location

Hospital General de Pachuca

Pachuca, 42070, Mexico

Location

Hospital de Ciudad Valles

San Luis Potosí City, Mexico

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rosaura Esperanza Benitez Pérez

  PRINCIPAL INVESTIGATOR

• Felipe Monrroy López

  PRINCIPAL INVESTIGATOR

• Blanca Nohemí Zamora Mendoza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blind placebo control
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double blind placebo control

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: June 30, 2020
• Study Start: October 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (3)