Clinical Impact of BACTEK-R in Subject With Mild Pneumonia Due to COVID-19 Infection
NCT ID: NCT04363814
Last Updated: 2021-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2020-06-10
2022-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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)
Control
Subject included in the control group will receive standard therapy for COVID-19.
No interventions assigned to this group
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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BioClever 2005 S.L.
OTHER
Inmunotek S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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Martín Medrano, MD
Role: PRINCIPAL_INVESTIGATOR
Nicolas Batlle, MD
Role: PRINCIPAL_INVESTIGATOR
Raymundo Hernández
Role: PRINCIPAL_INVESTIGATOR
Natalia García
Role: PRINCIPAL_INVESTIGATOR
M. Polanco
Role: PRINCIPAL_INVESTIGATOR
Guillermo Ángeles
Role: STUDY_DIRECTOR
Locations
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Hospital Metropolitano Santiago
Santiago de los Caballeros, , Dominican Republic
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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MV130-SLG-35
Identifier Type: -
Identifier Source: org_study_id