Covid19Phase 3BacmuneNCT04452643
Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to COVID-19 Infection in Healthcare Personnel
A Phase 3 study testing BACMUNE (MV130) in people with Covid19, run by Inmunotek S.L. at 3 sites in Mexico.
Trial summary
The purpose of this trial is to assess the effect of immunotherapy with the bacterial preparation MV130 on the spread and course of SARS-CoV-2 infection in highly exposed subjets, as is the case with healthcare personnel. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Covid19
- What is being tested?
- BACMUNE (MV130)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesMexico
- Study dates
- Oct 2020to Dec 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Health personnel who are or have been in contact with patients with disease due to SARS-COV-2 infection within the last 14 days before randomization.
- Negative result for test against COVID-19.
- Subjects who have given informed consent.
- Men or women aged between 18 and 65 years, both included.
- Subjects who have a smartphone where they can load an APP for monitoring the symptoms.
Who cannot join
- Subjects who are participating in another clinical trial.
- Subjects who are unable to offer cooperation and/or have serious psychiatric disorders.
- Subjects who are allergic to any of the compounds included into MV130.
- Subjects who present contraindications to any of the components of BACMUNE (MV130).
- Subjects who are not able to comply with the dosage regimen.
- Subjects with immunodeficiencies.
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- Subjects with malignancy involving the bone marrow or lymphoid systems.
- Pregnant or suspected pregnant women and breastfeeding women.
- Subjects in medical treatment that affects the response of the immune system. It includes corticosteroids (equal to or more than 20 mg for more than 2 weeks), immunosuppressants, biological agents (such as anti TNF-alpha monoclonal antibodies, etc.).
- Subjects with HIV.
- Subjects under treatment with metformin.
- Subjects treated with Sertraline.
- Subjects treated with statins.
Trial locations and contacts
3 sites in 1 country.
Mexico3 sites
Instituto Nacional de Enfermedades Respiratorias (INER)
Mexico City, Ciudad de México
Hospital General de Pachuca
Pachuca, 42070
Hospital de Ciudad Valles
San Luis Potosí City
About this study
Official title: Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial on the Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to SARS-CoV-2 Infection in Healthcare Personnel
The purpose of this trial is to assess the effect of immunotherapy with the bacterial preparation MV130 on the spread and course of SARS-CoV-2 infection in highly exposed subjets, as is the case with healthcare personnel.
Read the detailed description
This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy of BACMUNE (MV130) in the prevention of disease due to SARS-VoC-2 infection in healthcare personnel
- Conditions
- Covid19
- Being tested
- BACMUNE (MV130), Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BACMUNE (MV130)Biological
BACMUNE (MV130) 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)
PlaceboOther
Placebo is a solution on sodium chloride at 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Bacmune (MV130) | Active comparator | Subject included in the active group will receive Bacmune. The dose consists on 2 spray puff every 12 hours for 45 days. Receives: Biological: BACMUNE (MV130) |
| Placebo | Placebo comparator | Subject included in the placebo group will receive placebo. The dose consists on 2 spray puff every 12 hours for 45 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of subjects with COVID-19
Incidence of subjects with COVID-19, defined by the presence of:
- Fever
- Any of the respiratory signs and/or symptoms: cough, dyspnea, respiratory failure, runny nose/nasal obstruction.
- Positive test for SARS-COV-2 (PCR o serology)
Measured: 60 days
Severity of COVID-19
Incidence of severe COVID-19, defined by CURB > 2 and/or death
Measured: 60 days
Secondary outcomes (7)
Seroconversion to SARS-CoV-2
Rate of subjects with seroconversion to SARS-CoV-2 (negative serology at the beginning of the study and positive at the end of the study
Measured: 60 days
Subjects with symptoms
Rate of subjects with any symptoms, whether confirmed, probable or suspected, according to the WHO definition
Measured: 60 days
Hospital admission due to COVID-19
The effect of the treatment on the severity of the disease will be measured based on the rate of subjects requiring hospital admission for COVID-19
Measured: 60 days
Admission to an intensive care unit due to COVID-19
The effect of the treatment on the severity of the disease will be measured based on the rate of subjects who require admission to an intensive care unit for COVID-19
- Time from confirmation of SARS-CoV-2 infection to the appearance of symptoms.
Measured: 60 days
Elapsed time until hospitalization
Elapsed time until the first symptoms of COVID-19 appears to hospitalization due to COVID-19.
Measured: 60 days
Elapsed time until admission into an care unit for COVID-19
Elapsed time until the first symptoms of COVID-19 appears to admission into an intensive care unit pro COVID-19.
Measured: 60 days
Elapsed time until death not related to COVID-19
Elapsed time until the first symptoms of COVID-19 appears to death from any cause not related to COVID-19.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study startOct 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Not authorized by Cofepris (Mexico Competent Regulatory Authority)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Inmunotek S.L.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind placebo control
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inmunotek S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rosaura Esperanza Benitez Pérez, Principal investigatorFelipe Monrroy López, Principal investigatorBlanca Nohemí Zamora Mendoza, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452643
- Sponsor's protocol ID
- MV130-SLG-037
- Acronym
- Bacmune
- Status last verified
- Oct 2020
- First submitted
- 26 Jun 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial on the Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to SARS-CoV-2 Infection in Healthcare Personnel
- ClinicalTrials.gov ID
- NCT04452643
- Acronym / sponsor ID
- Bacmune / MV130-SLG-037
- Conditions
- Covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not authorized by Cofepris (Mexico Competent Regulatory Authority)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Inmunotek S.L.Industry (pharma, biotech, devices)
- Study start
- Oct 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to assess the effect of immunotherapy with the bacterial preparation MV130 on the spread and course of SARS-CoV-2 infection in highly exposed subjets, as is the case with healthcare personnel.
Detailed description
This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy of BACMUNE (MV130) in the prevention of disease due to SARS-VoC-2 infection in healthcare personnel
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double blind placebo control
| Arm | Type | Receives |
|---|---|---|
| Bacmune (MV130) | Active comparator | Biological: BACMUNE (MV130)Subject included in the active group will receive Bacmune. The dose consists on 2 spray puff every 12 hours for 45 days. |
| Placebo | Placebo comparator | Other: PlaceboSubject included in the placebo group will receive placebo. The dose consists on 2 spray puff every 12 hours for 45 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Health personnel who are or have been in contact with patients with disease due to SARS-COV-2 infection within the last 14 days before randomization.
- Negative result for test against COVID-19.
- Subjects who have given informed consent.
- Men or women aged between 18 and 65 years, both included.
- Subjects who have a smartphone where they can load an APP for monitoring the symptoms.
Key exclusion criteria (13 listed)
- Subjects who are participating in another clinical trial.
- Subjects who are unable to offer cooperation and/or have serious psychiatric disorders.
- Subjects who are allergic to any of the compounds included into MV130.
- Subjects who present contraindications to any of the components of BACMUNE (MV130).
- Subjects who are not able to comply with the dosage regimen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BACMUNE (MV130)BACMUNE (MV130) 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) | Biological | Bacmune (MV130) |
| PlaceboPlacebo is a solution on sodium chloride at 0.9% | Other | Placebo |
Primary outcome
Incidence of subjects with COVID-19
Time frame: 60 days
Incidence of subjects with COVID-19, defined by the presence of: * Fever * Any of the respiratory signs and/or symptoms: cough, dyspnea, respiratory failure, runny nose/nasal obstruction. * Positive test for SARS-COV-2 (PCR o serology)
Severity of COVID-19
Time frame: 60 days
Incidence of severe COVID-19, defined by CURB > 2 and/or death
7 secondary outcomes
Seroconversion to SARS-CoV-2
Time frame: 60 days
Subjects with symptoms
Time frame: 60 days
Hospital admission due to COVID-19
Time frame: 60 days
Admission to an intensive care unit due to COVID-19
Time frame: 60 days
Elapsed time until hospitalization
Time frame: 60 days
Elapsed time until admission into an care unit for COVID-19
Time frame: 60 days
Elapsed time until death not related to COVID-19
Time frame: 60 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosaura Esperanza Benitez Pérez principal investigator
Felipe Monrroy López principal investigator
Blanca Nohemí Zamora Mendoza principal investigator
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BACMUNE (MV130) in people with Covid19, run by Inmunotek S.L. at 3 sites in Mexico.
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 5 inclusion and 13 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: withdrawn, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mexico. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence of subjects with COVID-19 (time frame: 60 days). 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?
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 2 Nov 2020.