Status:
UNKNOWN
Clinical Impact of BACTEK-R in Subject With Mild Pneumonia Due to COVID-19 Infection
Lead Sponsor:
Inmunotek S.L.
Collaborating Sponsors:
BioClever 2005 S.L.
Conditions:
COVID-19
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- \- 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
- \- 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
Key Trial Info
Start Date :
June 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04363814
Start Date
June 10 2020
End Date
January 31 2022
Last Update
November 11 2021
Active Locations (1)
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1
Hospital Metropolitano Santiago
Santiago de los Caballeros, Dominican Republic, 51000