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

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

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

Study Overview

• Status: Unknown
• Conditions: Covid-19; Sars-CoV2
• Intervention / Treatment: Biological: RUTI® vaccine; Biological: Placebo

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: Interventional
• Enrollment (Anticipated): 315
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias i Pujol UBP Riscos Laborals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sick leave for SARS-CoV-2	Number of days of documented sick leave for SARS-CoV-2	Up to 4 months
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
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
Professional category	Number of MD, nursing, personnel management and services, etc.	Up to 4 months
Fever	Number of days of self-reported fever (≥38 ºC)	Up to 4 months
Incidence of self-reported acute respiratory symptoms	Cumulative incidence of self-reported acute respiratory symptoms	Up to 4 months
Days of self-reported acute respiratory symptoms	Number of days of self-reported acute respiratory symptoms	Up to 4 months
Incidence of pneumonia	Number of participants with pneumonia confirmed by X-ray	Up to 4 months
Incidence of death from SARS-CoV-2 infection	Cumulative incidence of death from documented SARS-CoV-2 infection	Up to 4 months
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
Days in ICU	Number of days admitted to the ICU for documented SARS-CoV-2 infection	Up to 4 months
Incidence of mechanical ventilation	Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection	Up to 4 months
Incidence of hospital admissions	Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection	Up to 4 months
Days of hospitalization	Number of days of hospitalization for documented SARS-CoV-2 infection	Up to 4 months
Incidence of SARS-CoV-2 antibodies	Incidence of SARS-CoV-2 antibodies at the end of the study period	Final visit
Types of antibodies detected	Frequency and levels of immunoglobulin IgG and immunoglobulin IgM	Final visit
Levels of SARS-CoV-2 antibodies	Levels of SARS-CoV-2 antibodies at the end of the study period	Final visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Fundació Institut Germans Trias i Pujol
• Investigators: Study Chair: Pere-Joan Cardona, MD, PhD, IGTP

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 30, 2020
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (ACTUAL): July 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: RUTICOVID19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No