A Phase 2 interventional study of RUTI® vaccine and Placebo in Covid-19, sponsored by RUTI Immunotherapeutics S.L.. Completed at 6 sites in Argentina. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-26.
Sponsored by RUTI Immunotherapeutics S.L. · Phase 2, Interventional, and Prevention
The aim of this study is to explore potential for reduction of incidence and/or morbidity of SARS-CoV-2 infection in healthcare personnel. The study will include a comparison between placebo and RUTI® vaccine in a 2:1 design.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 251 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with RUTI Immunotherapeutics S.L. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Population:
Exclusion Criteria:
Severely immunocompromised people. This exclusion category includes:
Participants will receive two dose of RUTI® vaccine at the baseline visit and after 2 weeks +/- 3 days, which will be administered subcutaneously in the deltoid region at a dose of 25 µg of fragmented, purified and liposomed heat-inactivated Mycobacterium tuberculosis bacilli in an injection volume of 0.3 mL.
Biological: RUTI® vaccine
Participants will receive two dose of physiological serum will be administered subcutaneously in the deltoid region at the baseline visit and after 2 weeks +/- 3 days.
Biological: Placebo
Each dose of the RUTI® vaccine contains 25 µg of fragmented, purified and liposomed heat-inactivated Mycobacterium tuberculosis bacilli in a total volum of 0,3mL.
Physiological serum, 0.9% NaCl, will be used as a placebo.
Documented cumulative incidence of SARS-CoV-2 infection
Percent of positive serology at the end of the study or positive PCR test in the course of routine clinical practice
Time frame: 6 months
Sick leave for SARS-CoV-2
Number of days of documented sick leave for SARS-CoV-2
Time frame: 6 months
Days off work due to the quarantine
The number of days off work due to the quarantine imposed as a consequence to have acute respiratory symptoms, fever or infection documented by SARS-CoV-2
Time frame: 6 months
Quarantine imposed by close contact outside the center with SARS-CoV-2 positive
Number of days of quarantine imposed by close contact outside the center with SARS-CoV-2 positive
Time frame: 6 months
Fever
Number of days of self-reported fever (≥38 ºC)
Time frame: 6 months
Incidence of self-reported acute respiratory symptoms
Cumulative incidence of self-reported acute respiratory symptoms
Time frame: 6 months
Days of self-reported acute respiratory symptoms
Number of days of self-reported acute respiratory symptoms
Time frame: 6 months
Incidence of pneumonia
Presence of compatible symptoms and radiological or tomographic focal alteration in the context of a confirmed diagnosis of Covid-19 infection and without evidence of other concomitant pathologies
Time frame: 6 months
Incidence of death from SARS-CoV-2 infection
Cumulative incidence of death from documented SARS-CoV-2 infection
Time frame: 6 months
Incidence of admissions to Intensive Care Unit (ICU)
Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection
Time frame: 6 months
Days in ICU
Number of days admitted to the ICU for documented SARS-CoV-2 infection
Time frame: 6 months
Incidence of mechanical ventilation
Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection
Time frame: 6 months
Incidence of hospital admissions
Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection
Time frame: 6 months
Days of hospitalization
Number of days of hospitalization for documented SARS-CoV-2 infection
Time frame: 6 months
Incidence of SARS-CoV-2 antibodies
Incidence of SARS-CoV-2 antibodies at the end of the study period
Time frame: Study completion, an average of 1 year
Types of antibodies detected
Frequency of immunoglobulin IgG and immunoglobulin IgM
Time frame: Study completion, an average of 1 year
Levels of SARS-CoV-2 antibodies
Levels of SARS-CoV-2 antibodies
Time frame: Study completion, an average of 1 year
Incidence of Treatment-Emergent Adverse Events
All adverse events reported by the subjects, both serious and non-serious, will be collected. All events related to a SARS-CoV-2 infection will be exempted from collection as part of the associated symptoms
Time frame: 6 months
Plan to share: No
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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