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

November 10, 2021 updated by: Inmunotek S.L.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Dominican Republic
      • Santiago De Los Caballeros, Dominican Republic, 51000
        • Hospital Metropolitano Santiago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bactek-R
Subject included in the experimental group will receive Bactek- R.The dose consists on 3 spray puff every 6 hours for 2 weeks.
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)
No Intervention: Control
Subject included in the control group will receive standard therapy for COVID-19.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical recovery
Time Frame: 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.
2 weeks
Clinical worsening
Time Frame: 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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical severity
Time Frame: 2 weeks
Symptom (fever, cough, dyspnea, myalgia, diarrhea and so on) will be daily record and classified as mild, moderate, severe.
2 weeks
Time to symptoms remission
Time Frame: 2 weeks
Time of reduction or disappearance of the symptoms
2 weeks
Medication Use
Time Frame: 2 weeks
Record of all the medication administered to the subject
2 weeks
Hospitalization time
Time Frame: 2 weeks
Time from the subject's admission to the coronavirus unit until discharge
2 weeks
Blood routine test
Time Frame: Days 1 and 7
Blood routine test will be carried out days 1 and 7
Days 1 and 7
Heart rate
Time Frame: 2 weeks
Heart rate will be followed everyday during time frame
2 weeks
Blood pressure
Time Frame: 2 weeks
Blood pressure will be followed everyday during time frame
2 weeks
Cardiac auscultation
Time Frame: 2 weeks
Cardiac auscultation will be recorded everyday during time frame
2 weeks
Oxygen saturation
Time Frame: 2 weeks
Blood oxygen saturation will be followed everyday during time frame
2 weeks
Adverse events
Time Frame: 2 weeks
Adverse events during treatment
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inmunotek S.L.

Collaborators

BioClever 2005 S.L.

Investigators

  • Principal Investigator: Martín Medrano, MD
  • Principal Investigator: Nicolas Batlle, MD
  • Principal Investigator: Raymundo Hernández
  • Principal Investigator: Natalia García
  • Principal Investigator: M. Polanco
  • Study Director: Guillermo Ángeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2020

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 31, 2022

Study Registration Dates

First Submitted

April 19, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 27, 2020

Study Record Updates

Last Update Posted (Actual)

November 11, 2021

Last Update Submitted That Met QC Criteria

November 10, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MV130-SLG-35

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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