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

NCT04363814 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-11-11

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • BioClever 2005 S.L.

    collaborator OTHER

  • Inmunotek S.L.

    lead INDUSTRY

Principal Investigators

  • Martín Medrano, MD

  • Nicolas Batlle, MD

  • Raymundo Hernández

  • Natalia García

  • M. Polanco

  • Guillermo Ángeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-10
Primary Completion
2022-01-01
Completion
2022-01-31

Countries

  • Dominican Republic

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04363814 on ClinicalTrials.gov