Clinical Impact of BACTEK-R in Subject With Mild Pneumonia Due to COVID-19 Infection

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Biological: Bactek-R


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bactek-R<br>Subject included in the experimental group will receive Bactek- R.The dose consists on 3 spray puff every 6 hours for 2 weeks. | Biological: Bactek-R<br>* 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)<br>|
| No Intervention: Control<br>Subject included in the control group will receive standard therapy for COVID-19. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical recovery | 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. | 2 weeks | 
| Clinical worsening | 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. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical severity | Symptom (fever, cough, dyspnea, myalgia, diarrhea and so on) will be daily record and classified as mild, moderate, severe. | 2 weeks | 
| Time to symptoms remission | Time of reduction or disappearance of the symptoms | 2 weeks | 
| Medication Use | Record of all the medication administered to the subject | 2 weeks | 
| Hospitalization time | Time from the subject's admission to the coronavirus unit until discharge | 2 weeks | 
| Blood routine test | Blood routine test will be carried out days 1 and 7 | Days 1 and 7 | 
| Heart rate | Heart rate will be followed everyday during time frame | 2 weeks | 
| Blood pressure | Blood pressure will be followed everyday during time frame | 2 weeks | 
| Cardiac auscultation | Cardiac auscultation will be recorded everyday during time frame | 2 weeks | 
| Oxygen saturation | Blood oxygen saturation will be followed everyday during time frame | 2 weeks | 
| Adverse events | Adverse events during treatment | 2 weeks |