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COVID-19Phase 3NCT04363814

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

A Phase 3 study testing Bactek-R in people with COVID-19, run by Inmunotek S.L. at 1 site in Dominican Republic.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
COVID-19
What is being tested?
Bactek-R
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteDominican Republic
Study dates
10 Jun 2020to 31 Jan 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • - 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

Who cannot join

  • - 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.
Show all 11Show fewer
  • - 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

Trial locations and contacts

1 site in 1 country.

Dominican Republic1 site

  • Hospital Metropolitano Santiago

    Santiago de los Caballeros, 51000

Other trials in Dominican Republic

About this study

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

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.

Read the 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.

Conditions
COVID-19
Being tested
Bactek-R
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bactek-RBiological

    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)

Study groups in NCT04363814
Study groupRoleWhat they receive
Bactek-RExperimentalSubject included in the experimental group will receive Bactek- R.The dose consists on 3 spray puff every 6 hours for 2 weeks.
Receives: Biological: Bactek-R
ControlNo interventionSubject included in the control group will receive standard therapy for COVID-19.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 weeks

  2. 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.

    Measured: 2 weeks

Secondary outcomes (10)

  1. Clinical severity

    Symptom (fever, cough, dyspnea, myalgia, diarrhea and so on) will be daily record and classified as mild, moderate, severe.

    Measured: 2 weeks

  2. Time to symptoms remission

    Time of reduction or disappearance of the symptoms

    Measured: 2 weeks

  3. Medication Use

    Record of all the medication administered to the subject

    Measured: 2 weeks

  4. Hospitalization time

    Time from the subject's admission to the coronavirus unit until discharge

    Measured: 2 weeks

  5. Blood routine test

    Blood routine test will be carried out days 1 and 7

    Measured: Days 1 and 7

  6. Heart rate

    Heart rate will be followed everyday during time frame

    Measured: 2 weeks

  7. Blood pressure

    Blood pressure will be followed everyday during time frame

    Measured: 2 weeks

  8. Cardiac auscultation

    Cardiac auscultation will be recorded everyday during time frame

    Measured: 2 weeks

  9. Oxygen saturation

    Blood oxygen saturation will be followed everyday during time frame

    Measured: 2 weeks

  10. Adverse events

    Adverse events during treatment

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2020
  2. Study start10 Jun 2020
  3. Primary completion1 Jan 2022 (estimated)
  4. Study completion31 Jan 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04363814
Sponsor's protocol ID
MV130-SLG-35
Status last verified
Nov 2021
First submitted
19 Apr 2020
Last updated
11 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28799230

  • 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.

    PubMed 29561355

  • 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.

    PubMed 25330031

  • 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.

    PubMed 27573928

  • 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.

    PubMed 21391984

  • 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.

    PubMed 30527360

  • 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.

    PubMed 30619296

  • 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;2006(4):CD004974. doi: 10.1002/14651858.CD004974.pub2.

    PubMed 17054227

  • 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.

    PubMed 15366329

  • 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.

    PubMed 30779677

  • 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.

    PubMed 31316504

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bactek-R in people with COVID-19, run by Inmunotek S.L. at 1 site in Dominican Republic.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical recovery (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04363814, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.

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