COVID-19
Conditions
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.
Interventions
BIOLOGICALBactek-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)
Sponsors
BioClever 2005 S.L.
Inmunotek S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical recovery | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Medication Use | 2 weeks | Record of all the medication administered to the subject |
| Hospitalization time | 2 weeks | Time from the subject's admission to the coronavirus unit until discharge |
| Blood routine test | Days 1 and 7 | Blood routine test will be carried out days 1 and 7 |
| Heart rate | 2 weeks | Heart rate will be followed everyday during time frame |
| Clinical severity | 2 weeks | Symptom (fever, cough, dyspnea, myalgia, diarrhea and so on) will be daily record and classified as mild, moderate, severe. |
| Cardiac auscultation | 2 weeks | Cardiac auscultation will be recorded everyday during time frame |
| Oxygen saturation | 2 weeks | Blood oxygen saturation will be followed everyday during time frame |
| Adverse events | 2 weeks | Adverse events during treatment |
| Blood pressure | 2 weeks | Blood pressure will be followed everyday during time frame |
| Time to symptoms remission | 2 weeks | Time of reduction or disappearance of the symptoms |
Countries
Dominican Republic
Outcome results
None listed