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

Phase 3

• Conditions: Covid-19; Sars-CoV2
• Interventions: Biological: Placebo; Biological: RUTI® vaccine

• Registration Number: NCT04453488
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-06-30
• Status Verified: 2020-07
• Study First Posted: 2020-07-01
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-29
• Study Start: 2020-07-30
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 315

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
RUTI® vaccine	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.

Primary Outcome Measures

Name	Time	Method
Documented cumulative incidence of SARS-CoV-2 infection	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

Name	Time	Method
Quarantine imposed by close contact outside the center with SARS-CoV-2 positive	Up to 4 months	Number of days of quarantine imposed by close contact outside the center with SARS-CoV-2 positive
Incidence of hospital admissions	Up to 4 months	Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection
Days of hospitalization	Up to 4 months	Number of days of hospitalization for documented SARS-CoV-2 infection
Fever	Up to 4 months	Number of days of self-reported fever (≥38 ºC)
Professional category	Up to 4 months	Number of MD, nursing, personnel management and services, etc.
Incidence of admissions to Intensive Care Unit (ICU)	Up to 4 months	Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection
Sick leave for SARS-CoV-2	Up to 4 months	Number of days of documented sick leave for SARS-CoV-2
Days off work due to the quarantine	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
Incidence of self-reported acute respiratory symptoms	Up to 4 months	Cumulative incidence of self-reported acute respiratory symptoms
Days of self-reported acute respiratory symptoms	Up to 4 months	Number of days of self-reported acute respiratory symptoms
Incidence of death from SARS-CoV-2 infection	Up to 4 months	Cumulative incidence of death from documented SARS-CoV-2 infection
Incidence of pneumonia	Up to 4 months	Number of participants with pneumonia confirmed by X-ray
Days in ICU	Up to 4 months	Number of days admitted to the ICU for documented SARS-CoV-2 infection
Incidence of mechanical ventilation	Up to 4 months	Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection
Levels of SARS-CoV-2 antibodies	Final visit	Levels of SARS-CoV-2 antibodies at the end of the study period
Incidence of SARS-CoV-2 antibodies	Final visit	Incidence of SARS-CoV-2 antibodies at the end of the study period
Types of antibodies detected	Final visit	Frequency and levels of immunoglobulin IgG and immunoglobulin IgM

Trial Locations

Locations (2)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitari Germans Trias i Pujol UBP Riscos Laborals; 🇪🇸 Badalona, Barcelona, Spain