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

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ClinicalTrials.gov Identifier: NCT04453488
Recruitment Status : Not yet recruiting
First Posted : July 1, 2020
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Fundació Institut Germans Trias i Pujol

Tracking Information
First Submitted Date  ICMJE June 30, 2020
First Posted Date  ICMJE July 1, 2020
Last Update Posted Date July 29, 2020
Estimated Study Start Date  ICMJE July 30, 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2020)
Documented cumulative incidence of SARS-CoV-2 infection [ Time Frame: Up to 4 months ]
% positive serology at the end of the study or positive PCR test in the course of routine clinical practice
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2020)
  • Sick leave for SARS-CoV-2 [ Time Frame: Up to 4 months ]
    Number of days of documented sick leave for SARS-CoV-2
  • Days off work due to the quarantine [ Time Frame: Up to 4 months ]
    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 [ Time Frame: Up to 4 months ]
    Number of days of quarantine imposed by close contact outside the center with SARS-CoV-2 positive
  • Professional category [ Time Frame: Up to 4 months ]
    Number of MD, nursing, personnel management and services, etc.
  • Fever [ Time Frame: Up to 4 months ]
    Number of days of self-reported fever (≥38 ºC)
  • Incidence of self-reported acute respiratory symptoms [ Time Frame: Up to 4 months ]
    Cumulative incidence of self-reported acute respiratory symptoms
  • Days of self-reported acute respiratory symptoms [ Time Frame: Up to 4 months ]
    Number of days of self-reported acute respiratory symptoms
  • Incidence of pneumonia [ Time Frame: Up to 4 months ]
    Number of participants with pneumonia confirmed by X-ray
  • Incidence of death from SARS-CoV-2 infection [ Time Frame: Up to 4 months ]
    Cumulative incidence of death from documented SARS-CoV-2 infection
  • Incidence of admissions to Intensive Care Unit (ICU) [ Time Frame: Up to 4 months ]
    Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection
  • Days in ICU [ Time Frame: Up to 4 months ]
    Number of days admitted to the ICU for documented SARS-CoV-2 infection
  • Incidence of mechanical ventilation [ Time Frame: Up to 4 months ]
    Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection
  • Incidence of hospital admissions [ Time Frame: Up to 4 months ]
    Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection
  • Days of hospitalization [ Time Frame: Up to 4 months ]
    Number of days of hospitalization for documented SARS-CoV-2 infection
  • Incidence of SARS-CoV-2 antibodies [ Time Frame: Final visit ]
    Incidence of SARS-CoV-2 antibodies at the end of the study period
  • Types of antibodies detected [ Time Frame: Final visit ]
    Frequency and levels of immunoglobulin IgG and immunoglobulin IgM
  • Levels of SARS-CoV-2 antibodies [ Time Frame: Final visit ]
    Levels of SARS-CoV-2 antibodies at the end of the study period
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2020)
  • Sick leave for SARS-CoV-2 [ Time Frame: Up to 4 months ]
    Number of days of documented sick leave for SARS-CoV-2
  • Days off work due to the quarantine [ Time Frame: Up to 4 months ]
    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 [ Time Frame: Up to 4 months ]
    Number of days of quarantine imposed by close contact outside the center with SARS-CoV-2 positive
  • Professional category [ Time Frame: Up to 4 months ]
    Number of MD, nursing, personnel management and services, etc.
  • Fever [ Time Frame: Up to 4 months ]
    Number of days of self-reported fever (≥38 ºC)
  • Incidence of self-reported acute respiratory symptoms [ Time Frame: Up to 4 months ]
    Cumulative incidence of self-reported acute respiratory symptoms
  • Days of self-reported acute respiratory symptoms [ Time Frame: Up to 4 months ]
    Number of days of self-reported acute respiratory symptoms
  • Incidence of pneumonia [ Time Frame: Up to 4 months ]
    Number of participants with pneumonia confirmed by X-ray
  • Incidence of death from SARS-CoV-2 infection [ Time Frame: Up to 4 months ]
    Cumulative incidence of death from documented SARS-CoV-2 infection
  • Incidence of admissions to ICU [ Time Frame: Up to 4 months ]
    Cumulative incidence of admissions to intensive care for documented SARS-CoV-2 infection
  • Days in ICU [ Time Frame: Up to 4 months ]
    Number of days admitted to the ICU for documented SARS-CoV-2 infection
  • Incidence of mechanical ventilation [ Time Frame: Up to 4 months ]
    Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection
  • Incidence of hospital admissions [ Time Frame: Up to 4 months ]
    Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection
  • Days of hospitalization [ Time Frame: Up to 4 months ]
    Number of days of hospitalization for documented SARS-CoV-2 infection
  • Incidence of SARS-CoV-2 antibodies [ Time Frame: Final visit ]
    Incidence of SARS-CoV-2 antibodies at the end of the study period
  • Types of antibodies detected [ Time Frame: Final visit ]
    Frequency and levels of IgG and IgM
  • Levels of SARS-CoV-2 antibodies [ Time Frame: Final visit ]
    Levels of SARS-CoV-2 antibodies at the end of the study period
Current Other Pre-specified Outcome Measures
 (submitted: June 30, 2020)
  • AEs [ Time Frame: Up to 4 months ]
    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.
  • SAEs [ Time Frame: Up to 4 months ]
    All those Adverse Events that lead to hospitalization of the patient, that endanger his life or cause or may cause death.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Evaluate the Efficacy of RUTI® Against SARS-COV-2 Infection (COVID-19) in Healthcare Workers
Official Title  ICMJE Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of the RUTI® Vaccine to Prevent SARS-CoV-2 Infection
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Covid-19
  • Sars-CoV2
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: RUTI® vaccine
    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.
    Intervention: Biological: RUTI® vaccine
  • Placebo Comparator: Placebo
    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: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 30, 2020)
315
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pere-Joan Cardona, MD, PhD +34 93 033 0527 ext 6400 pjcardona@igtp.cat
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04453488
Other Study ID Numbers  ICMJE RUTICOVID19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fundació Institut Germans Trias i Pujol
Study Sponsor  ICMJE Fundació Institut Germans Trias i Pujol
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Pere-Joan Cardona, MD, PhD IGTP
PRS Account Fundació Institut Germans Trias i Pujol
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP