COVID19NCT04452773
Clinical Trial to Evaluate the Efficacy of Food Supplement Manremyc® Against SARS- COV-2 Infection (COVID-19) in Healthcare Workers
A study testing Manremyc in people with COVID19, run by Reig Jofre Group at 5 sites in Spain.
Trial summary
The purpose of this study is to assess the efficacy of Manremyc® food supplement for reduce the incidence of SARS-CoV-2 infection in a high risk population, as healthcare workers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID19
- What is being tested?
- Manremyc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- 5 sitesSpain
- Study dates
- 14 Jul 2020to Dec 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sign the Informed Consent before initiating the selection procedures.
- Health system workers working in contact with subjects potentially infected with SARS-CoV-2.
- People ≥ 18 years.
- Availability to meet the requirements of the protocol.
- Negative Rapid Serological Test of SARS-CoV-2
Who cannot join
- Previous SARS-CoV-2 infection
- Pregnancy or breastfeeding.
- Suspected of active viral or bacterial infection.
- Symptoms compatible with COVID-19, despite a negative PCR test.
- Vaccination in the last 4 weeks or planned vaccination during the study period, regardless of the type of vaccine.
- Participation in a research that requires experimental intervention (does not include observational studies) in the previous month before signing the Consent or during the study.
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- Severely immunocompromised people. This exclusion category includes:
- Subjects with human immunodeficiency virus (HIV-1).
- Neutropenic subjects with less than 500 neutrophils / mm3.
- Subjects with solid organ transplantation.
- Subjects with bone marrow transplantation.
- Subjects undergoing chemotherapy.
- Subjects with primary immunodeficiency.
- Severe lymphopenia with less than 400 lymphocytes / mm3.
- Treatment with any anti-cytokine therapy.
- Oral treatment with steroids, defined as daily doses of 10 mg prednisone or equivalent for more than 3 months.
- Malignancy, or active solid or non-solid lymphoma from the previous two years.
- BCG vaccination in the last 10 years.
- Treatment with Manremyc® for the last 6 months.
- Chloroquine or hydroxychloroquine administration in the last two weeks.
- Direct involvement in the design or execution of the MANRECOVID19 clinical trial.
- Retirement, transfer, long-term leave (> 1 month) due to scheduled surgery or any other event that makes it impossible to work in person at your health center during the months following the recruitment to the study.
- Employee at the health center <22 hours per week.
- Do not have a smartphone.
- Detection by the investigator of lack of knowledge or willingness to participate and comply with all requirements of the protocol.
- Any other findings that, at the discretion of the investigator, may compromise compliance with the protocol or that may influence significantly the interpretation or the results of the effects of probiotic.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites, 5 recruiting
- Not yet recruiting
Hospital Universitari Germans Trias i Pujol UBP Riscos Laborals, Badalona,
Badalona, 08916
Joan Matllo, Dr., 670282689, jmatlloaguilar@gencat.cat
Pere Joan Cardona, MD, PhD
- Not yet recruiting
CAP Cornellà (La Gavarra)
Cornellà de Llobregat, Barcelona, 08940
Mª Betlem Salvador, Dr., +34 93 857 55 45, bsalvador@ambitcp.catsalut.net
Sofía Berlanga, +34 93 857 55 45, sberlanga.cp.ics@gencat.cat
- Not yet recruiting
CAP Maresme
Mataró, Barcelona, 08303
Pere Torán, Dr., +34 93 741 60 73, ptoran.bnm.ics@gencat.cat
Noemí Lamonja, +34 93 741 60 73, noemilamonjavicente@gmail.com
- Recruiting
Cap Sant Fèlix
Sabadell, Barcelona, 08203
Concepció Violant, Dr., 93 693 27 32, cviolanf.mn.ics@gencat.cat
Mª José Argerich, Dr., 675785198, mjargerich.mn.ics@gencat.cat
- Not yet recruiting
EAP Riu Nord
Santa Coloma de Gramenet, BArcelona, 08921
Magda Alemany, Dr.
Eli Sánchez
About this study
Official title: Double-blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of the Manremyc® Food Supplement to Prevent SARS-CoV-2 Infection
The purpose of this study is to assess the efficacy of Manremyc® food supplement for reduce the incidence of SARS-CoV-2 infection in a high risk population, as healthcare workers.
- Conditions
- COVID19
- Being tested
- Manremyc, 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.
ManremycDietary supplement
Manremyc is composed by 10E5 heat-inactivated Mycobacterium s. manresensis bacilli
PlaceboDietary supplement
Same excipients than active arm without bacilli.
| Study group | Role | What they receive |
|---|---|---|
| Manremyc | Experimental | Participants will receive daily oral administration of a capsule of Manremyc for 14 days in the morning with breakfast Receives: Dietary Supplement: Manremyc |
| Placebo | Placebo comparator | Participants will receive daily oral administration of a capsule of Placebo for 14 days in the morning with breakfast Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documented cumulative incidence of SARS-CoV-2 infection
% of positive serology at the end of the study or positive PCR test in the course of routine clinical practice
Measured: up to 4 months
Secondary outcomes (16)
Documented sick leave for SARS-CoV-2
Number of days Documented as sick leave for SARS-CoV-2
Measured: up to 4 months (cumulative)
days off work due to the quarantine
Number of days off work due to the quarantine imposed as a consequence to have acute respiratory symptoms, fever or infection documented by SARS-CoV-2
Measured: up to 4 months
Quarantine imposed by close contact outside the center with SARS-CoV-2 positive
Number of days in quarantine imposed by close contact outside the center with SARS-CoV-2 positive
Measured: up to 4 months
Fever
Number of days of self-reported fever (≥38 ºC)
Measured: Up to 4 months
Cumulative incidence of self-reported acute respiratory symptoms
Cumulative incidence of self-reported acute respiratory symptoms
Measured: up to 4 months
Number of days of self-reported acute respiratory symptoms
Number of days of self-reported acute respiratory symptoms
Measured: up to 4 months
Incidence of pneumonia
Number of participants with pneumonia confirmed by X-ray
Measured: up to 4 months
Cumulative incidence of death from documented SARS-CoV-2 infection
Cumulative incidence of death from documented SARS-CoV-2 infection
Measured: Up to 4 months
Incidence of admission to ICU
Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection
Measured: Up to 4 months
Days in IUC
Number of days admitted to the ICU for documented SARS-CoV-2 infection
Measured: Up to 4 months
Incidence of mechanical ventilation
Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection
Measured: Up to 4 months
Incidence of hospital admissions
Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection
Measured: Up to 4 months
Days of hospitalization
Number of days of hospitalization for documented SARS-CoV-2 infection
Measured: Up to 4 months
Levels of IgG
Levels of IgG
Measured: Up to 4 months
Levels of IgM
Levels of IgM
Measured: Up to 4 months
Levels of SARS-CoV-2 antibodies at the end of the study period
Levels of SARS-CoV-2 antibodies at the end of the study period
Measured: Up to 4 months
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 start14 Jul 2020
- Primary completionSep 2020 (estimated)
- Study completionDec 2021 (estimated)
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.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reig Jofre Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452773
- Sponsor's protocol ID
- MANRECOVID19
- Status last verified
- Jul 2020
- First submitted
- 25 Jun 2020
- Last updated
- 15 Jul 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 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of the Manremyc® Food Supplement to Prevent SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04452773
- Acronym / sponsor ID
- MANRECOVID19
- Conditions
- COVID19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Reig Jofre GroupIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- Sep 2020 (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 study is to assess the efficacy of Manremyc® food supplement for reduce the incidence of SARS-CoV-2 infection in a high risk population, as healthcare workers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manremyc | Experimental | Dietary Supplement: ManremycParticipants will receive daily oral administration of a capsule of Manremyc for 14 days in the morning with breakfast |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants will receive daily oral administration of a capsule of Placebo for 14 days in the morning with breakfast |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sign the Informed Consent before initiating the selection procedures.
- Health system workers working in contact with subjects potentially infected with SARS-CoV-2.
- People ≥ 18 years.
- Availability to meet the requirements of the protocol.
- Negative Rapid Serological Test of SARS-CoV-2
Key exclusion criteria (26 listed)
- Previous SARS-CoV-2 infection
- Pregnancy or breastfeeding.
- Suspected of active viral or bacterial infection.
- Symptoms compatible with COVID-19, despite a negative PCR test.
- Vaccination in the last 4 weeks or planned vaccination during the study period, regardless of the type of vaccine.
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 |
|---|---|---|
| ManremycManremyc is composed by 10E5 heat-inactivated Mycobacterium s. manresensis bacilli | Dietary supplement | Manremyc |
| PlaceboSame excipients than active arm without bacilli. | Dietary supplement | Placebo |
Primary outcome
Documented cumulative incidence of SARS-CoV-2 infection
Time frame: up to 4 months
% of positive serology at the end of the study or positive PCR test in the course of routine clinical practice
16 secondary outcomes
Documented sick leave for SARS-CoV-2
Time frame: up to 4 months (cumulative)
days off work due to the quarantine
Time frame: up to 4 months
Quarantine imposed by close contact outside the center with SARS-CoV-2 positive
Time frame: up to 4 months
Fever
Time frame: Up to 4 months
Cumulative incidence of self-reported acute respiratory symptoms
Time frame: up to 4 months
Number of days of self-reported acute respiratory symptoms
Time frame: up to 4 months
Incidence of pneumonia
Time frame: up to 4 months
Cumulative incidence of death from documented SARS-CoV-2 infection
Time frame: Up to 4 months
Incidence of admission to ICU
Time frame: Up to 4 months
Days in IUC
Time frame: Up to 4 months
Incidence of mechanical ventilation
Time frame: Up to 4 months
Incidence of hospital admissions
Time frame: Up to 4 months
Days of hospitalization
Time frame: Up to 4 months
Levels of IgG
Time frame: Up to 4 months
Levels of IgM
Time frame: Up to 4 months
Levels of SARS-CoV-2 antibodies at the end of the study period
Time frame: Up to 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manremyc in people with COVID19, run by Reig Jofre Group at 5 sites in Spain.
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 26 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 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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.
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?
Contact Pere Joan Cardona, MD, PhD (+34934978681, pjcardona@igtp.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Documented cumulative incidence of SARS-CoV-2 infection (time frame: up to 4 months). 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 15 Jul 2020.