Exploratory Study to Evaluate the Efficacy of RUTI® Against SARS-COV-2 Infection (COVID-19) in Healthcare Workers

NCT04903184 | Completed Phase 2

• 1 other identifier: RUTICOVID19-ARG
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 6

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.

Conditions

Covid-19

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (16)

• Sick leave for SARS-CoV-2

  6 months

• Days off work due to the quarantine

  6 months

• Quarantine imposed by close contact outside the center with SARS-CoV-2 positive

  6 months

• Fever

  6 months

• Incidence of self-reported acute respiratory symptoms

  6 months

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  6 months

Study Arms (2)

Group RUTI

EXPERIMENTAL

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

Group Placebo

PLACEBO COMPARATOR

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

Interventions

RUTI® vaccine BIOLOGICAL

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.

Group RUTI

Placebo BIOLOGICAL

Physiological serum, 0.9% NaCl, will be used as a placebo.

Group Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects with human immunodeficiency virus (HIV-1).
• Neutropenic subjects with less than 500 neutrophils / mm3.
• Subjects with solid organ transplantation.
• Subjects with bone marrow transplantation.
• Subjects undergoing chemotherapy.
• Subjects with primary immunodeficiency.
• Severe lymphopenia with less than 400 lymphocytes / mm3.
• Malignancy, or active solid or non-solid lymphoma from the previous two years.

Sponsors & Collaborators

• RUTI Immunotherapeutics S.L.: lead

Study Sites (6)

Hospital General de Agudos Dr. Ignacio Pirovano

Buenos Aires, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Location

Hospital General

Mendoza, Argentina

Location

Hospital José Néstor Lencinas

Mendoza, Argentina

Location

Hospital de Clínicas Presidente Dr. Nicolás Avellaneda

San Miguel de Tucumán, Argentina

Location

Hospital Materno Infantil "Dr. Héctor Quintana"

San Salvador de Jujuy, Argentina

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 26, 2021
• Study Start: January 6, 2021
• Primary Completion: November 11, 2021
• Study Completion: November 11, 2021
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

AR (6)