A Exploratory Phase II Clinical Trial, Double-blind, Randomized Placebo-controlled to Evaluate the Efficacy of RUTI® Against SARS-COV-2 Infection (COVID-19) in Healthcare Workers

RUTI Immunotherapeutics S.L.6 sites in 1 country251 target enrollmentJanuary 6, 2021

ConditionsCovid-19

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Covid-19
Sponsor: RUTI Immunotherapeutics S.L.
Enrollment: 251
Locations: 6
Primary Endpoint: Documented cumulative incidence of SARS-CoV-2 infection
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 6, 2021

End Date

November 11, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

RUTI Immunotherapeutics S.L.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Sign the Informed Consent before initiating the selection procedures.
•Population:
•Healthcare system workers working in contact with subjects potentially infected with SARS-CoV-2
•People between 18 years and 59 years
•Willingness to meet the requirements of the protocol.
•Negative Rapid Serological Test of SARS-CoV-2
•The participant must agree to use effective contraceptive methods during the study period, in case of childbearing age.

Exclusion Criteria

•Previous SARS-CoV-2 infection
•Pregnancy. Pregnancy test will be performed in case of doubt.
•Breastfeeding.
•Suspected of active viral or bacterial infection.
•Symptoms compatible with COVID-19, despite a negative polymerase chain reaction (PCR) test.
•Vaccination in the last 4 weeks or planned vaccination during the study period, except for influenza vaccine.
•Participation in a research that requires experimental intervention (does not include observational studies) in the previous month before signing the Consent or during the study.
•Severely immunocompromised people. This exclusion category includes:
•Subjects with human immunodeficiency virus (HIV-1).
•Neutropenic subjects with less than 500 neutrophils / mm

Outcomes

Primary Outcomes

Documented cumulative incidence of SARS-CoV-2 infection

Time Frame: 6 months

Percent of positive serology at the end of the study or positive PCR test in the course of routine clinical practice

Secondary Outcomes

Fever(6 months)
Incidence of death from SARS-CoV-2 infection(6 months)
Incidence of mechanical ventilation(6 months)
Incidence of hospital admissions(6 months)
Sick leave for SARS-CoV-2(6 months)
Days off work due to the quarantine(6 months)
Days of hospitalization(6 months)
Incidence of SARS-CoV-2 antibodies(Study completion, an average of 1 year)
Levels of SARS-CoV-2 antibodies(Study completion, an average of 1 year)
Quarantine imposed by close contact outside the center with SARS-CoV-2 positive(6 months)
Incidence of self-reported acute respiratory symptoms(6 months)
Days in ICU(6 months)
Types of antibodies detected(Study completion, an average of 1 year)
Days of self-reported acute respiratory symptoms(6 months)
Incidence of pneumonia(6 months)
Incidence of admissions to Intensive Care Unit (ICU)(6 months)