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

NCT04453488 | Unknown Phase 3

• 1 other identifier: RUTICOVID19
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess the efficacy of RUTI® vaccine preventing SARS-CoV-2 infection (COVID-19) in healthcare workers.

Conditions

Covid-19; Sars-CoV2

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 4 months

Secondary Outcomes (17)

• Sick leave for SARS-CoV-2

  Up to 4 months

• Days off work due to the quarantine

  Up to 4 months

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

  Up to 4 months

• Professional category

  Up to 4 months

• Fever

  Up to 4 months

Other Outcomes (2)

• AEs

  Up to 4 months

• SAEs

  Up to 4 months

Study Arms (2)

RUTI® vaccine

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

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.

RUTI® vaccine

Placebo BIOLOGICAL

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

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.
• Healthcare system workers working in contact with subjects potentially infected with SARS-CoV-2.
• People ≥ 18 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.
• Treatment with any anti-cytokine therapy.

Sponsors & Collaborators

• Fundació Institut Germans Trias i Pujol: lead

Study Sites (2)

Hospital Universitari Germans Trias i Pujol UBP Riscos Laborals

Badalona, Barcelona, 08916, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

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 Officials

• Pere-Joan Cardona, MD, PhD

  IGTP

  STUDY CHAIR

Central Study Contacts

Pere-Joan Cardona, MD, PhD

CONTACT

+34 93 033 0527; pjcardona@igtp.cat

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 1, 2020
• Study Start: July 30, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)