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
Biological: 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)
Other: Placebo
Placebo is a solution on sodium chloride at 0.9%
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.
Instituto Nacional de Enfermedades Respiratorias (INER)
Ciudad de México, Mexico
Hospital General de Pachuca
Pachuca de Soto, Mexico
Hospital de Ciudad Valles
San Luis Potosí, Mexico