Trials / Unknown
UnknownNCT04363814
Clinical Impact of BACTEK-R in Subject With Mild Pneumonia Due to COVID-19 Infection
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
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Inmunotek S.L. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Bactek-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) |
Timeline
- Start date
- 2020-06-10
- Primary completion
- 2022-01-01
- Completion
- 2022-01-31
- First posted
- 2020-04-27
- Last updated
- 2021-11-11
Locations
1 site across 1 country: Dominican Republic
Source: ClinicalTrials.gov record NCT04363814. Inclusion in this directory is not an endorsement.