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Clinical Trial Summary

The aim of this study is to assess the efficacy of the RUTI® vaccine in achieving clinical improvement of COVID-19 symptoms and to evaluate the safety of RUTI® in patients with SARS-CoV-2 infection. The study will include a comparison between placebo and RUTI® vaccine in a 1:1 design.


Clinical Trial Description

Once it has been confirmed that the patient meets the selection criteria, subjects will be randomly assigned to one of the two study groups: - Experimental group: Administration of RUTI® - Control group: Administration of Placebo (physiological serum) This randomization follows a 1:1 ratio. In this way, of the total of 550 subjects who intend to be recruited for this study, 275 will receive the prophylactic treatment, and 275 will receive the placebo treatment. Neither patient nor the doctor will know if the subject is part of the experimental group or the control group, that is to say, the treatment assignment is blind. All subjets will receive just one inoculation of treatment (either RUTI® or Pacebo). The standard treatment of COVID-19, if is necessary, will continue after RUTI® administration according to the local guidelines. All the subjets will be followed for one month after the first day of RUTI® or Placebo treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05115019
Study type Interventional
Source RUTI Immunotherapeutics S.L.
Contact
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date December 2021
Completion date April 2022

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