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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04363814
Recruitment Status : Recruiting
First Posted : April 27, 2020
Last Update Posted : June 30, 2020
Sponsor:
Collaborator:
BioClever 2005 S.L.
Information provided by (Responsible Party):
Inmunotek S.L.

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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Bactek-R Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 10, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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.



Primary Outcome Measures :
  1. 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. 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.


Secondary Outcome Measures :
  1. 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. Time to symptoms remission [ Time Frame: 2 weeks ]
    Time of reduction or disappearance of the symptoms

  3. Medication Use [ Time Frame: 2 weeks ]
    Record of all the medication administered to the subject

  4. Hospitalization time [ Time Frame: 2 weeks ]
    Time from the subject's admission to the coronavirus unit until discharge

  5. Blood routine test [ Time Frame: Days 1 and 7 ]
    Blood routine test will be carried out days 1 and 7

  6. Heart rate [ Time Frame: 2 weeks ]
    Heart rate will be followed everyday during time frame

  7. Blood pressure [ Time Frame: 2 weeks ]
    Blood pressure will be followed everyday during time frame

  8. Cardiac auscultation [ Time Frame: 2 weeks ]
    Cardiac auscultation will be recorded everyday during time frame

  9. Oxygen saturation [ Time Frame: 2 weeks ]
    Blood oxygen saturation will be followed everyday during time frame

  10. Adverse events [ Time Frame: 2 weeks ]
    Adverse events during treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04363814


Contacts
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Contact: Guillermo Ángeles, MD 809 399 3520 gangeles@gmail.com
Contact: Miguel Casanovas, PhD; MD +34916510010 mcasanovas@inmunotek.com

Locations
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Dominican Republic
Hospital Metropolitano Santiago Recruiting
Santiago De Los Caballeros, Dominican Republic, 51000
Contact: Nicolas Batlle, MD    +1 829-947-2222      
Sponsors and Collaborators
Inmunotek S.L.
BioClever 2005 S.L.
Investigators
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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:
Randomised double-blind placebo-controlled, parallel, multi-centre clinical trial of sublingual bacterial vaccine in children with recurrent bronchospasm (wheezing attacks) for the evaluation of efficacy, security and clinical impact.

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Responsible Party: Inmunotek S.L.
ClinicalTrials.gov Identifier: NCT04363814    
Other Study ID Numbers: MV130-SLG-35
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections