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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04363814
• Other study ID #: MV130-SLG-35
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 10, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: November 2021
• Source: Inmunotek S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 31, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Pneumonia

Intervention

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)

Locations

Country	Name	City	State
Dominican Republic	Hospital Metropolitano Santiago	Santiago De Los Caballeros

Sponsors (2)

Lead Sponsor	Collaborator
Inmunotek S.L.	BioClever 2005 S.L.

Country where clinical trial is conducted

Dominican Republic, 

References & Publications (12)

Alecsandru D, Valor L, Sánchez-Ramón S, Gil J, Carbone J, Navarro J, Rodríguez J, Rodríguez-Sainz C, Fernández-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. — View Citation

Cirauqui C, Benito-Villalvilla C, Sánchez-Ramón S, Sirvent S, Diez-Rivero CM, Conejero L, Brandi P, Hernández-Cillero L, Ochoa JL, Pérez-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. — View 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. Review. — View 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. — View Citation

García González LA, Arrutia Díez 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. — View 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. — View 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. — View 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.

Sánchez Ramón 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. Review. English, Spanish. — View Citation

Sánchez-Ramón S, Conejero L, Netea MG, Sancho D, Palomares Ó, 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. Review. — View Citation

Sánchez-Ramón S, Pérez 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. Review. — View 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. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Clinical severity	Symptom (fever, cough, dyspnea, myalgia, diarrhea and so on) will be daily record and classified as mild, moderate, severe.	2 weeks
Secondary	Time to symptoms remission	Time of reduction or disappearance of the symptoms	2 weeks
Secondary	Medication Use	Record of all the medication administered to the subject	2 weeks
Secondary	Hospitalization time	Time from the subject's admission to the coronavirus unit until discharge	2 weeks
Secondary	Blood routine test	Blood routine test will be carried out days 1 and 7	Days 1 and 7
Secondary	Heart rate	Heart rate will be followed everyday during time frame	2 weeks
Secondary	Blood pressure	Blood pressure will be followed everyday during time frame	2 weeks
Secondary	Cardiac auscultation	Cardiac auscultation will be recorded everyday during time frame	2 weeks
Secondary	Oxygen saturation	Blood oxygen saturation will be followed everyday during time frame	2 weeks
Secondary	Adverse events	Adverse events during treatment	2 weeks