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

Primary Purpose

Covid-19, Sars-CoV2

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
RUTI® vaccine
Placebo
Sponsored by
Fundació Institut Germans Trias i Pujol
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Previous SARS-CoV-2 infection
  2. Pregnancy. Pregnancy test will be performed in case of doubt.
  3. Breastfeeding.
  4. Suspected of active viral or bacterial infection.
  5. Symptoms compatible with COVID-19, despite a negative polymerase chain reaction (PCR) test.
  6. Vaccination in the last 4 weeks or planned vaccination during the study period, except for influenza vaccine.
  7. 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.

  8. Severely immunocompromised people. This exclusion category includes:

    1. Subjects with human immunodeficiency virus (HIV-1).
    2. Neutropenic subjects with less than 500 neutrophils / mm3.
    3. Subjects with solid organ transplantation.
    4. Subjects with bone marrow transplantation.
    5. Subjects undergoing chemotherapy.
    6. Subjects with primary immunodeficiency.
    7. Severe lymphopenia with less than 400 lymphocytes / mm3.
    8. Treatment with any anti-cytokine therapy.
    9. Oral treatment with steroids, defined as daily doses of 10 mg prednisone or equivalent for more than 3 months.
  9. Malignancy, or active solid or non-solid lymphoma from the previous two years.
  10. BCG vaccination in the last 1year.
  11. Soy allergy.

12 Chloroquine or hydroxychloroquine administration in the last two weeks.

13. Direct involvement in the design or execution of the RUTICOVID19 clinical trial.

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.

15. Employee at the health center <22 hours per week.

16. Do not have a smartphone.

17. Detection by the researcher of lack of knowledge or willingness to participate and comply with all requirements of the protocol.

18. Any other findings that, at the discretion of the researcher, may compromise compliance with the protocol or that may influence significantly the interpretation or the results of the effects of the vaccine.

Sites / Locations

  • Hospital Universitari Germans Trias i Pujol UBP Riscos Laborals
  • Hospital de la Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RUTI® vaccine

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Sick leave for SARS-CoV-2
Number of days of documented sick leave for SARS-CoV-2
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
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
Professional category
Number of MD, nursing, personnel management and services, etc.
Fever
Number of days of self-reported fever (≥38 ºC)
Incidence of self-reported acute respiratory symptoms
Cumulative incidence of self-reported acute respiratory symptoms
Days of self-reported acute respiratory symptoms
Number of days of self-reported acute respiratory symptoms
Incidence of pneumonia
Number of participants with pneumonia confirmed by X-ray
Incidence of death from SARS-CoV-2 infection
Cumulative incidence of death from documented SARS-CoV-2 infection
Incidence of admissions to Intensive Care Unit (ICU)
Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection
Days in ICU
Number of days admitted to the ICU for documented SARS-CoV-2 infection
Incidence of mechanical ventilation
Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection
Incidence of hospital admissions
Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection
Days of hospitalization
Number of days of hospitalization for documented SARS-CoV-2 infection
Incidence of SARS-CoV-2 antibodies
Incidence of SARS-CoV-2 antibodies at the end of the study period
Types of antibodies detected
Frequency and levels of immunoglobulin IgG and immunoglobulin IgM
Levels of SARS-CoV-2 antibodies
Levels of SARS-CoV-2 antibodies at the end of the study period

Full Information

First Posted
June 30, 2020
Last Updated
July 27, 2020
Sponsor
Fundació Institut Germans Trias i Pujol
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1. Study Identification

Unique Protocol Identification Number
NCT04453488
Brief Title
Clinical Trial to Evaluate the Efficacy of RUTI® Against SARS-COV-2 Infection (COVID-19) in Healthcare Workers
Official Title
Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of the RUTI® Vaccine to Prevent SARS-CoV-2 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 30, 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut Germans Trias i Pujol

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19, Sars-CoV2

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
315 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RUTI® vaccine
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
RUTI® vaccine
Intervention Description
Each dose of the RUTI® vaccine contains 25 µg of fragmented, purified and liposomed heat-inactivated Mycobacterium tuberculosis bacilli.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Physiological serum, 0.9% NaCl, will be used as a placebo
Primary Outcome Measure Information:
Title
Documented cumulative incidence of SARS-CoV-2 infection
Description
% 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
Secondary Outcome Measure Information:
Title
Sick leave for SARS-CoV-2
Description
Number of days of documented sick leave for SARS-CoV-2
Time Frame
Up to 4 months
Title
Days off work due to the quarantine
Description
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
Title
Quarantine imposed by close contact outside the center with SARS-CoV-2 positive
Description
Number of days of quarantine imposed by close contact outside the center with SARS-CoV-2 positive
Time Frame
Up to 4 months
Title
Professional category
Description
Number of MD, nursing, personnel management and services, etc.
Time Frame
Up to 4 months
Title
Fever
Description
Number of days of self-reported fever (≥38 ºC)
Time Frame
Up to 4 months
Title
Incidence of self-reported acute respiratory symptoms
Description
Cumulative incidence of self-reported acute respiratory symptoms
Time Frame
Up to 4 months
Title
Days of self-reported acute respiratory symptoms
Description
Number of days of self-reported acute respiratory symptoms
Time Frame
Up to 4 months
Title
Incidence of pneumonia
Description
Number of participants with pneumonia confirmed by X-ray
Time Frame
Up to 4 months
Title
Incidence of death from SARS-CoV-2 infection
Description
Cumulative incidence of death from documented SARS-CoV-2 infection
Time Frame
Up to 4 months
Title
Incidence of admissions to Intensive Care Unit (ICU)
Description
Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection
Time Frame
Up to 4 months
Title
Days in ICU
Description
Number of days admitted to the ICU for documented SARS-CoV-2 infection
Time Frame
Up to 4 months
Title
Incidence of mechanical ventilation
Description
Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection
Time Frame
Up to 4 months
Title
Incidence of hospital admissions
Description
Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection
Time Frame
Up to 4 months
Title
Days of hospitalization
Description
Number of days of hospitalization for documented SARS-CoV-2 infection
Time Frame
Up to 4 months
Title
Incidence of SARS-CoV-2 antibodies
Description
Incidence of SARS-CoV-2 antibodies at the end of the study period
Time Frame
Final visit
Title
Types of antibodies detected
Description
Frequency and levels of immunoglobulin IgG and immunoglobulin IgM
Time Frame
Final visit
Title
Levels of SARS-CoV-2 antibodies
Description
Levels of SARS-CoV-2 antibodies at the end of the study period
Time Frame
Final visit
Other Pre-specified Outcome Measures:
Title
AEs
Description
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
Title
SAEs
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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 / 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. Oral treatment with steroids, defined as daily doses of 10 mg prednisone or equivalent for more than 3 months. Malignancy, or active solid or non-solid lymphoma from the previous two years. BCG vaccination in the last 1year. Soy allergy. 12 Chloroquine or hydroxychloroquine administration in the last two weeks. 13. Direct involvement in the design or execution of the RUTICOVID19 clinical trial. 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. 15. Employee at the health center <22 hours per week. 16. Do not have a smartphone. 17. Detection by the researcher of lack of knowledge or willingness to participate and comply with all requirements of the protocol. 18. Any other findings that, at the discretion of the researcher, may compromise compliance with the protocol or that may influence significantly the interpretation or the results of the effects of the vaccine.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pere-Joan Cardona, MD, PhD
Phone
+34 93 033 0527
Ext
6400
Email
pjcardona@igtp.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pere-Joan Cardona, MD, PhD
Organizational Affiliation
IGTP
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitari Germans Trias i Pujol UBP Riscos Laborals
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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