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
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Clinical recovery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •- Subjects who voluntarily sign informed consent forms
- •- Both genders.
- •- Subjects aged between 18 and 70 years.
- •Subjects capable of complying with the treatment
- •- Subjects admitted to hospital with non-severe pneumonia (CURB-65≤2) by COVID-19
- •- Confirmatory test for COVID-19 infection
Exclusion Criteria
- •- Subjects who has not signed informed consent forms
- •- Subjects included in another clinical trial.
- •- Subjects under treatment with immunosuppressants.
- •- Subjects in treatment with another type of immunotherapy.
- •- Subjects who are or have been undergoing treatment with metformin.
- •- Subjects who are or have been treated with statins.
- •- Subjects who are or have been under treatment with sertraline.
- •- Pregnant women.
- •- Subjects who cannot offer cooperation and / or have serious psychiatric disorders.
- •Subjects who are allergic to any of the components of BACTEK-R (MV130).
- •- Subjects with pathologies described in the Charlson index
Outcomes
Primary Outcomes
Clinical recovery
Time Frame: 2 weeks
Number of subjects presenting a improvement in their clinical condition from day 1 to 14 that lead their hospital discharged. Based on the measure of the secondary outcomes.
Clinical worsening
Time Frame: 2 weeks
Number of subjects presenting a worsening in their clinical condition from day 1 to 14 that leads to their admission to the intensive care unit or their death. Based on the measure of the secondary outcomes.
Secondary Outcomes
- Hospitalization time(2 weeks)
- Blood routine test(Days 1 and 7)
- Oxygen saturation(2 weeks)
- Time to symptoms remission(2 weeks)
- Clinical severity(2 weeks)
- Medication Use(2 weeks)
- Blood pressure(2 weeks)
- Adverse events(2 weeks)
- Heart rate(2 weeks)
- Cardiac auscultation(2 weeks)