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

Covid-19 Clinical Trial

Official title:

Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of the RUTI® Vaccine to Prevent SARS-CoV-2 Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04453488
• Other study ID #: RUTICOVID19
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 30, 2020
• Est. completion date: December 2020

Study information

• Verified date: July 2020
• Source: Fundació Institut Germans Trias i Pujol
• Contact: Pere-Joan Cardona, MD, PhD
• Phone: +34 93 033 0527
• Email: pjcardona[@]igtp.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 315
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid-19
• Infection
• Sars-CoV2

Intervention

Biological:
• RUTI® vaccine
Each dose of the RUTI® vaccine contains 25 µg of fragmented, purified and liposomed heat-inactivated Mycobacterium tuberculosis bacilli.
• Placebo
Physiological serum, 0.9% NaCl, will be used as a placebo

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol UBP Riscos Laborals	Badalona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut Germans Trias i Pujol

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	AEs	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.	Up to 4 months
Other	SAEs	All those Adverse Events that lead to hospitalization of the patient, that endanger his life or cause or may cause death.	Up to 4 months
Primary	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	Sick leave for SARS-CoV-2	Number of days of documented sick leave for SARS-CoV-2	Up to 4 months
Secondary	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	Up to 4 months
Secondary	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	Up to 4 months
Secondary	Professional category	Number of MD, nursing, personnel management and services, etc.	Up to 4 months
Secondary	Fever	Number of days of self-reported fever (=38 ºC)	Up to 4 months
Secondary	Incidence of self-reported acute respiratory symptoms	Cumulative incidence of self-reported acute respiratory symptoms	Up to 4 months
Secondary	Days of self-reported acute respiratory symptoms	Number of days of self-reported acute respiratory symptoms	Up to 4 months
Secondary	Incidence of pneumonia	Number of participants with pneumonia confirmed by X-ray	Up to 4 months
Secondary	Incidence of death from SARS-CoV-2 infection	Cumulative incidence of death from documented SARS-CoV-2 infection	Up to 4 months
Secondary	Incidence of admissions to Intensive Care Unit (ICU)	Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection	Up to 4 months
Secondary	Days in ICU	Number of days admitted to the ICU for documented SARS-CoV-2 infection	Up to 4 months
Secondary	Incidence of mechanical ventilation	Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection	Up to 4 months
Secondary	Incidence of hospital admissions	Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection	Up to 4 months
Secondary	Days of hospitalization	Number of days of hospitalization for documented SARS-CoV-2 infection	Up to 4 months
Secondary	Incidence of SARS-CoV-2 antibodies	Incidence of SARS-CoV-2 antibodies at the end of the study period	Final visit
Secondary	Types of antibodies detected	Frequency and levels of immunoglobulin IgG and immunoglobulin IgM	Final visit
Secondary	Levels of SARS-CoV-2 antibodies	Levels of SARS-CoV-2 antibodies at the end of the study period	Final visit