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Trial - NCT04452643


Column Value
Trial registration number NCT04452643
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04452643

First author
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Miguel Casanovas

Contact
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

mcasanovas@inmunotek.com

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-06-30

Recruitment status
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

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
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- 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.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Inmunotek S.L.

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

65

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mexico

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Health workers

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Severity of COVID-19;Incidence of subjects with COVID-19

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 171, "treatment_name": "Bacmune (mv130)", "treatment_type": "Other anti-infectives", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]