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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Covid-19 Sars-CoV2 Biological: RUTI® vaccine Biological: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of the RUTI® Vaccine to Prevent SARS-CoV-2 Infection
Estimated Study Start Date : July 30, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
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.
Biological: RUTI® vaccine
Each dose of the RUTI® vaccine contains 25 µg of fragmented, purified and liposomed heat-inactivated Mycobacterium tuberculosis bacilli.

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Sick leave for SARS-CoV-2 [ Time Frame: Up to 4 months ]
    Number of days of documented sick leave for SARS-CoV-2

  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

  3. 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

  4. Professional category [ Time Frame: Up to 4 months ]
    Number of MD, nursing, personnel management and services, etc.

  5. Fever [ Time Frame: Up to 4 months ]
    Number of days of self-reported fever (≥38 ºC)

  6. Incidence of self-reported acute respiratory symptoms [ Time Frame: Up to 4 months ]
    Cumulative incidence of self-reported acute respiratory symptoms

  7. Days of self-reported acute respiratory symptoms [ Time Frame: Up to 4 months ]
    Number of days of self-reported acute respiratory symptoms

  8. Incidence of pneumonia [ Time Frame: Up to 4 months ]
    Number of participants with pneumonia confirmed by X-ray

  9. Incidence of death from SARS-CoV-2 infection [ Time Frame: Up to 4 months ]
    Cumulative incidence of death from documented SARS-CoV-2 infection

  10. 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

  11. Days in ICU [ Time Frame: Up to 4 months ]
    Number of days admitted to the ICU for documented SARS-CoV-2 infection

  12. Incidence of mechanical ventilation [ Time Frame: Up to 4 months ]
    Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection

  13. Incidence of hospital admissions [ Time Frame: Up to 4 months ]
    Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection

  14. Days of hospitalization [ Time Frame: Up to 4 months ]
    Number of days of hospitalization for documented SARS-CoV-2 infection

  15. Incidence of SARS-CoV-2 antibodies [ Time Frame: Final visit ]
    Incidence of SARS-CoV-2 antibodies at the end of the study period

  16. Types of antibodies detected [ Time Frame: Final visit ]
    Frequency and levels of immunoglobulin IgG and immunoglobulin IgM

  17. Levels of SARS-CoV-2 antibodies [ Time Frame: Final visit ]
    Levels of SARS-CoV-2 antibodies at the end of the study period


Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04453488


Contacts
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Contact: Pere-Joan Cardona, MD, PhD +34 93 033 0527 ext 6400 pjcardona@igtp.cat

Locations
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Spain
Hospital Universitari Germans Trias i Pujol UBP Riscos Laborals
Badalona, Barcelona, Spain, 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Sponsors and Collaborators
Fundació Institut Germans Trias i Pujol
Investigators
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Study Chair: Pere-Joan Cardona, MD, PhD IGTP
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Responsible Party: Fundació Institut Germans Trias i Pujol
ClinicalTrials.gov Identifier: NCT04453488    
Other Study ID Numbers: RUTICOVID19
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection