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

Primary Purpose

COVID-19

Status
Active
Phase
Phase 3
Locations
Dominican Republic
Study Type
Interventional
Intervention
Bactek-R
Sponsored by
Inmunotek S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Metropolitano Santiago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bactek-R

Control

Arm Description

Subject included in the experimental group will receive Bactek- R.The dose consists on 3 spray puff every 6 hours for 2 weeks.

Subject included in the control group will receive standard therapy for COVID-19.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
April 19, 2020
Last Updated
November 10, 2021
Sponsor
Inmunotek S.L.
Collaborators
BioClever 2005 S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT04363814
Brief Title
Clinical Impact of BACTEK-R in Subject With Mild Pneumonia Due to COVID-19 Infection
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 10, 2020 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inmunotek S.L.
Collaborators
BioClever 2005 S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bactek-R
Arm Type
Experimental
Arm Description
Subject included in the experimental group will receive Bactek- R.The dose consists on 3 spray puff every 6 hours for 2 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subject included in the control group will receive standard therapy for COVID-19.
Intervention Type
Biological
Intervention Name(s)
Bactek-R
Intervention Description
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)
Primary Outcome Measure Information:
Title
Clinical recovery
Description
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
Title
Clinical worsening
Description
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
Secondary Outcome Measure Information:
Title
Clinical severity
Description
Symptom (fever, cough, dyspnea, myalgia, diarrhea and so on) will be daily record and classified as mild, moderate, severe.
Time Frame
2 weeks
Title
Time to symptoms remission
Description
Time of reduction or disappearance of the symptoms
Time Frame
2 weeks
Title
Medication Use
Description
Record of all the medication administered to the subject
Time Frame
2 weeks
Title
Hospitalization time
Description
Time from the subject's admission to the coronavirus unit until discharge
Time Frame
2 weeks
Title
Blood routine test
Description
Blood routine test will be carried out days 1 and 7
Time Frame
Days 1 and 7
Title
Heart rate
Description
Heart rate will be followed everyday during time frame
Time Frame
2 weeks
Title
Blood pressure
Description
Blood pressure will be followed everyday during time frame
Time Frame
2 weeks
Title
Cardiac auscultation
Description
Cardiac auscultation will be recorded everyday during time frame
Time Frame
2 weeks
Title
Oxygen saturation
Description
Blood oxygen saturation will be followed everyday during time frame
Time Frame
2 weeks
Title
Adverse events
Description
Adverse events during treatment
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - 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 Criteria: - 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martín Medrano, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicolas Batlle, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raymundo Hernández
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Natalia García
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
M. Polanco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guillermo Ángeles
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Metropolitano Santiago
City
Santiago De Los Caballeros
ZIP/Postal Code
51000
Country
Dominican Republic

12. IPD Sharing Statement

Plan to Share IPD
No
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28799230
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Clinical Impact of BACTEK-R in Subject With Mild Pneumonia Due to COVID-19 Infection

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