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

Inmunotek

Status and phase: Withdrawn; Phase 3

Conditions: Covid19

Treatments: Other: Placebo; Biological: BACMUNE (MV130)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04452643

MV130-SLG-037

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Bacmune (MV130)

Active Comparator group

Description:

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

Treatment:

Biological: BACMUNE (MV130)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo