A Phase 3 interventional study of RUTI® vaccine and Placebo in Covid-19 and Sars-CoV2, sponsored by Fundació Institut Germans Trias i Pujol. Status unknown at 2 sites in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-29.
Sponsored by Fundació Institut Germans Trias i Pujol · Phase 3, Interventional, and Prevention
The purpose of this study is to assess the efficacy of RUTI® vaccine preventing SARS-CoV-2 infection (COVID-19) in healthcare workers.
The aim of this study is to assess the efficacy of RUTI® vaccine preventing SARS-CoV-2 infection (COVID-19) in healthcare workers. The study will include a comparison between placebo and RUTI® vaccine.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 315 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Fundació Institut Germans Trias i Pujol is the lead sponsor of 25 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Severely immunocompromised people. This exclusion category includes:
12 Chloroquine or hydroxychloroquine administration in the last two weeks.
14 Retirement, transfer, long-term leave (> 1 month) due to scheduled surgery or any other event that makes it impossible to work in person at your health center during the months following the recruitment to the study.
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.
Physiological serum, 0.9% NaCl, will be used as a placebo
Documented cumulative incidence of SARS-CoV-2 infection
% positive serology at the end of the study or positive PCR test in the course of routine clinical practice
Time frame: Up to 4 months
Sick leave for SARS-CoV-2
Number of days of documented sick leave for SARS-CoV-2
Time frame: Up to 4 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: Up to 4 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: Up to 4 months
Professional category
Number of MD, nursing, personnel management and services, etc.
Time frame: Up to 4 months
Fever
Number of days of self-reported fever (≥38 ºC)
Time frame: Up to 4 months
Incidence of self-reported acute respiratory symptoms
Cumulative incidence of self-reported acute respiratory symptoms
Time frame: Up to 4 months
Days of self-reported acute respiratory symptoms
Number of days of self-reported acute respiratory symptoms
Time frame: Up to 4 months
Incidence of pneumonia
Number of participants with pneumonia confirmed by X-ray
Time frame: Up to 4 months
Incidence of death from SARS-CoV-2 infection
Cumulative incidence of death from documented SARS-CoV-2 infection
Time frame: Up to 4 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: Up to 4 months
Days in ICU
Number of days admitted to the ICU for documented SARS-CoV-2 infection
Time frame: Up to 4 months
Incidence of mechanical ventilation
Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection
Time frame: Up to 4 months
Incidence of hospital admissions
Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection
Time frame: Up to 4 months
Days of hospitalization
Number of days of hospitalization for documented SARS-CoV-2 infection
Time frame: Up to 4 months
Incidence of SARS-CoV-2 antibodies
Incidence of SARS-CoV-2 antibodies at the end of the study period
Time frame: Final visit
Types of antibodies detected
Frequency and levels of immunoglobulin IgG and immunoglobulin IgM
Time frame: Final visit
Levels of SARS-CoV-2 antibodies
Levels of SARS-CoV-2 antibodies at the end of the study period
Time frame: Final visit
AEs
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: Up to 4 months
SAEs
All those Adverse Events that lead to hospitalization of the patient, that endanger his life or cause or may cause death.
Time frame: Up to 4 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fundació Institut Germans Trias i Pujol