Not authorized by Cofepris (Mexico Competent Regulatory Authority)

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.

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

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.

Double blind placebo control