The purpose of the study is to confirm if BACTEK-R (MV130) provides clinical benefit insubject with mild pneumonia (CURB-65≤2) by COVID-19 admitted to the Hospital.
This is a prospective, open-label, randomized pilot study to evaluate the efficacy and
safety of BACTEK-R (MV130) in subject with mild pneumonia due to COVID-19 infection.
Biological: Bactek-R
BACTEK-R 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)
Inclusion Criteria:
1.
- Subjects who voluntarily sign informed consent forms
2.
- Both genders.
3.
- Subjects aged between 18 and 70 years.
4. -Subjects capable of complying with the treatment
5.
- Subjects admitted to hospital with non-severe pneumonia (CURB-65≤2) by COVID-19
6.
- Confirmatory test for COVID-19 infection
Exclusion Criteria:
1.
- Subjects who has not signed informed consent forms
2.
- Subjects included in another clinical trial.
3.
- Subjects under treatment with immunosuppressants.
4.
- Subjects in treatment with another type of immunotherapy.
5.
- Subjects who are or have been undergoing treatment with metformin.
6.
- Subjects who are or have been treated with statins.
7.
- Subjects who are or have been under treatment with sertraline.
8.
- Pregnant women.
9.
- Subjects who cannot offer cooperation and / or have serious psychiatric
disorders.
10. -Subjects who are allergic to any of the components of BACTEK-R (MV130).
11.
- Subjects with pathologies described in the Charlson index
Hospital Metropolitano Santiago
Santiago De Los Caballeros, Dominican Republic