NCT04452773

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
315

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable covid19

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

July 14, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

June 25, 2020

Last Update Submit

July 14, 2020

Conditions

COVID19

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 4 months

Secondary Outcomes (16)

  • Documented sick leave for SARS-CoV-2

    up to 4 months (cumulative)

  • days off work due to the quarantine

    up to 4 months

  • Quarantine imposed by close contact outside the center with SARS-CoV-2 positive

    up to 4 months

  • Fever

    Up to 4 months

  • Cumulative incidence of self-reported acute respiratory symptoms

    up to 4 months

  • +11 more secondary outcomes

Other Outcomes (2)

  • AEs

    Up to 4 months

  • SAEs

    Up to 4 moths

Study Arms (2)

Manremyc

EXPERIMENTAL

Participants will receive daily oral administration of a capsule of Manremyc for 14 days in the morning with breakfast

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

Dietary Supplement: Placebo

Interventions

ManremycDIETARY_SUPPLEMENT

Manremyc is composed by 10E5 heat-inactivated Mycobacterium s. manresensis bacilli

Manremyc
PlaceboDIETARY_SUPPLEMENT

Same excipients than active arm without bacilli.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CAP Cornellà (La Gavarra)

Cornellà de Llobregat, Barcelona, 08940, Spain

NOT YET RECRUITING

CAP Maresme

Mataró, Barcelona, 08303, Spain

NOT YET RECRUITING

Cap Sant Fèlix

Sabadell, Barcelona, 08203, Spain

RECRUITING

EAP Riu Nord

Santa Coloma de Gramenet, BArcelona, 08921, Spain

NOT YET RECRUITING

Hospital Universitari Germans Trias i Pujol UBP Riscos Laborals, Badalona,

Badalona, 08916, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Pere Joan Cardona, MD, PhD

CONTACT

+34934978681pjcardona@igtp.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2020

First Posted

June 30, 2020

Study Start

July 14, 2020

Primary Completion

September 1, 2020

Study Completion

December 1, 2021

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(5)