Covid19
Conditions
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 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
Interventions
BIOLOGICALBACMUNE (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)
OTHERPlacebo
Placebo is a solution on sodium chloride at 0.9%
Sponsors
Inmunotek S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double blind placebo control
Intervention model description
Double blind placebo control
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of subjects with COVID-19 | 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 | 60 days | Incidence of severe COVID-19, defined by CURB \> 2 and/or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital admission due to COVID-19 | 60 days | 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 |
| Admission to an intensive care unit due to COVID-19 | 60 days | 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. |
| Seroconversion to SARS-CoV-2 | 60 days | 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 |
| Elapsed time until admission into an care unit for COVID-19 | 60 days | Elapsed time until the first symptoms of COVID-19 appears to admission into an intensive care unit pro COVID-19. |
| Elapsed time until death not related to COVID-19 | 60 days | Elapsed time until the first symptoms of COVID-19 appears to death from any cause not related to COVID-19. |
| Elapsed time until hospitalization | 60 days | Elapsed time until the first symptoms of COVID-19 appears to hospitalization due to COVID-19. |
| Subjects with symptoms | 60 days | Rate of subjects with any symptoms, whether confirmed, probable or suspected, according to the WHO definition |
Countries
Mexico
Outcome results
None listed