Clinical trial NCT04363814: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: Inmunotek S.L.
Sponsor class: INDUSTRY
Collaborators: name: BioClever 2005 S.L.
First posted: 2020-04-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Clinical recovery
timeFrame: 2 weeks
measure: Clinical worsening
timeFrame: 2 weeks
Secondary outcomes:
measure: Clinical severity
timeFrame: 2 weeks
measure: Time to symptoms remission
timeFrame: 2 weeks
measure: Medication Use
timeFrame: 2 weeks
measure: Hospitalization time
timeFrame: 2 weeks
measure: Blood routine test
timeFrame: Days 1 and 7
measure: Heart rate
timeFrame: 2 weeks
measure: Blood pressure
timeFrame: 2 weeks
measure: Cardiac auscultation
timeFrame: 2 weeks
measure: Oxygen saturation
timeFrame: 2 weeks
measure: Adverse events
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Santiago De Los Caballeros
country: Dominican Republic
facility: Hospital Metropolitano Santiago
Study officials:
name: Martín Medrano, MD
role: PRINCIPAL_INVESTIGATOR
name: Nicolas Batlle, MD
role: PRINCIPAL_INVESTIGATOR
name: Raymundo Hernández
role: PRINCIPAL_INVESTIGATOR
name: Natalia García
role: PRINCIPAL_INVESTIGATOR
name: M. Polanco
role: PRINCIPAL_INVESTIGATOR
name: Guillermo Ángeles
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.