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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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)
Hospital Metropolitano Santiago
Santiago de los Caballeros, Dominican Republic
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.
Time frame: 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.
Time frame: 2 weeks
Clinical severity
Symptom (fever, cough, dyspnea, myalgia, diarrhea and so on) will be daily record and classified as mild, moderate, severe.
Time frame: 2 weeks
Time to symptoms remission
Time of reduction or disappearance of the symptoms
Time frame: 2 weeks
Medication Use
Record of all the medication administered to the subject
Time frame: 2 weeks
Hospitalization time
Time from the subject's admission to the coronavirus unit until discharge
Time frame: 2 weeks
Blood routine test
Blood routine test will be carried out days 1 and 7
Time frame: Days 1 and 7
Heart rate
Heart rate will be followed everyday during time frame
Time frame: 2 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Blood pressure
Blood pressure will be followed everyday during time frame
Time frame: 2 weeks
Cardiac auscultation
Cardiac auscultation will be recorded everyday during time frame
Time frame: 2 weeks
Oxygen saturation
Blood oxygen saturation will be followed everyday during time frame
Time frame: 2 weeks
Adverse events
Adverse events during treatment
Time frame: 2 weeks