Official Title
A Prospective, Open-label, Randomized Pilot Study (Including a Control Group) of BACTEK-R (MV130), Administered Sublingually to Assess the Clinical Impact in Subjects With Mild Pneumonia Due to COVID-19
Brief Summary

The purpose of the study is to confirm if BACTEK-R (MV130) provides clinical benefit in subject with mild pneumonia (CURB-65≤2) by COVID-19 admitted to the Hospital.

Detailed Description

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.

Active, not recruiting
COVID-19

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)

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 70 Years
Countries
Dominican Republic
Locations

Hospital Metropolitano Santiago
Santiago De Los Caballeros, Dominican Republic

BioClever 2005 S.L.
NCT Number
MeSH Terms
COVID-19
Pneumonia