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

NCT04453488 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2020-07-29

No results posted yet for this study

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

Interventions

BIOLOGICAL

RUTI® vaccine

Each dose of the RUTI® vaccine contains 25 µg of fragmented, purified and liposomed heat-inactivated Mycobacterium tuberculosis bacilli.

BIOLOGICAL

Placebo

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

Sponsors & Collaborators

  • Fundació Institut Germans Trias i Pujol

    lead OTHER

Principal Investigators

  • Pere-Joan Cardona, MD, PhD · IGTP

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-30
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04453488 on ClinicalTrials.gov