Status:
WITHDRAWN
Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to COVID-19 Infection in Healthcare Personnel
Lead Sponsor:
Inmunotek S.L.
Conditions:
Covid19
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 ...
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 he...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04452643
Start Date
October 1 2020
End Date
December 1 2021
Last Update
November 2 2020
Active Locations (3)
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1
Instituto Nacional de Enfermedades Respiratorias (INER)
Mexico City, Mexico, Ciudad de México
2
Hospital General de Pachuca
Pachuca, Mexico, 42070
3
Hospital de Ciudad Valles
San Luis Potosí City, Mexico