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

NCT04363814 | Unknown Phase 3

• 1 other identifier: MV130-SLG-35
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• 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.

  2 weeks

• 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.

  2 weeks

Secondary Outcomes (10)

• Clinical severity

  2 weeks

• Time to symptoms remission

  2 weeks

• Medication Use

  2 weeks

• Hospitalization time

  2 weeks

• Blood routine test

  Days 1 and 7

Study Arms (2)

Bactek-R

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Bactek-R BIOLOGICAL

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)

Bactek-R

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Inmunotek S.L.: lead
• BioClever 2005 S.L.: collaborator

Study Sites (1)

Hospital Metropolitano Santiago

Santiago de los Caballeros, 51000, Dominican Republic

Location

Related Publications (12)

• Cirauqui C, Benito-Villalvilla C, Sanchez-Ramon S, Sirvent S, Diez-Rivero CM, Conejero L, Brandi P, Hernandez-Cillero L, Ochoa JL, Perez-Villamil B, Sancho D, Subiza JL, Palomares O. Human dendritic cells activated with MV130 induce Th1, Th17 and IL-10 responses via RIPK2 and MyD88 signalling pathways. Eur J Immunol. 2018 Jan;48(1):180-193. doi: 10.1002/eji.201747024. Epub 2017 Sep 14.

  PMID: 28799230 BACKGROUND

• Esposito S, Soto-Martinez ME, Feleszko W, Jones MH, Shen KL, Schaad UB. Nonspecific immunomodulators for recurrent respiratory tract infections, wheezing and asthma in children: a systematic review of mechanistic and clinical evidence. Curr Opin Allergy Clin Immunol. 2018 Jun;18(3):198-209. doi: 10.1097/ACI.0000000000000433.

  PMID: 29561355 BACKGROUND

• Sanchez-Ramon S, Perez de Diego R, Dieli-Crimi R, Subiza JL. Extending the clinical horizons of mucosal bacterial vaccines: current evidence and future prospects. Curr Drug Targets. 2014;15(12):1132-43. doi: 10.2174/1389450115666141020160705.

  PMID: 25330031 BACKGROUND

• Tejera-Alhambra M, Palomares O, Perez de Diego R, Diaz-Lezcano I, Sanchez-Ramon S. New Biological Insights in the Immunomodulatory Effects of Mucosal Polybacterial Vaccines in Clinical Practice. Curr Pharm Des. 2016;22(41):6283-6293. doi: 10.2174/1381612822666160829143129.

  PMID: 27573928 BACKGROUND

• Alecsandru D, Valor L, Sanchez-Ramon S, Gil J, Carbone J, Navarro J, Rodriguez J, Rodriguez-Sainz C, Fernandez-Cruz E. Sublingual therapeutic immunization with a polyvalent bacterial preparation in patients with recurrent respiratory infections: immunomodulatory effect on antigen-specific memory CD4+ T cells and impact on clinical outcome. Clin Exp Immunol. 2011 Apr;164(1):100-7. doi: 10.1111/j.1365-2249.2011.04320.x.

  PMID: 21391984 BACKGROUND

• Sanchez Ramon S, Manzanares M, Candelas G. MUCOSAL anti-infections vaccines: Beyond conventional vaccines. Reumatol Clin (Engl Ed). 2020 Jan-Feb;16(1):49-55. doi: 10.1016/j.reuma.2018.10.012. Epub 2018 Dec 7. English, Spanish.

  PMID: 30527360 BACKGROUND

• Sanchez-Ramon S, Conejero L, Netea MG, Sancho D, Palomares O, Subiza JL. Trained Immunity-Based Vaccines: A New Paradigm for the Development of Broad-Spectrum Anti-infectious Formulations. Front Immunol. 2018 Dec 17;9:2936. doi: 10.3389/fimmu.2018.02936. eCollection 2018.

  PMID: 30619296 BACKGROUND

• Del-Rio-Navarro BE, Espinosa Rosales F, Flenady V, Sienra-Monge JJ. Immunostimulants for preventing respiratory tract infection in children. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD004974. doi: 10.1002/14651858.CD004974.pub2.

  PMID: 17054227 BACKGROUND

• Lusuardi M. Challenging mucosal immunity with bacterial extracts to prevent respiratory infections: an old therapy revisited. Monaldi Arch Chest Dis. 2004 Jan-Mar;61(1):4-5. No abstract available.

  PMID: 15366329 BACKGROUND

• Garcia Gonzalez LA, Arrutia Diez F. Mucosal bacterial immunotherapy with MV130 highly reduces the need of tonsillectomy in adults with recurrent tonsillitis. Hum Vaccin Immunother. 2019;15(9):2150-2153. doi: 10.1080/21645515.2019.1581537. Epub 2019 Apr 17.

  PMID: 30779677 BACKGROUND

• Molero-Abraham M, Sanchez-Trincado JL, Gomez-Perosanz M, Torres-Gomez A, Subiza JL, Lafuente EM, Reche PA. Human Oral Epithelial Cells Impair Bacteria-Mediated Maturation of Dendritic Cells and Render T Cells Unresponsive to Stimulation. Front Immunol. 2019 Jun 28;10:1434. doi: 10.3389/fimmu.2019.01434. eCollection 2019.

  PMID: 31316504 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Martín Medrano, MD

  PRINCIPAL INVESTIGATOR

• Nicolas Batlle, MD

  PRINCIPAL INVESTIGATOR

• Raymundo Hernández

  PRINCIPAL INVESTIGATOR

• Natalia García

  PRINCIPAL INVESTIGATOR

• M. Polanco

  PRINCIPAL INVESTIGATOR

• Guillermo Ángeles

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: April 27, 2020
• Study Start: June 10, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 31, 2022
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1)