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

Phase 2

Completed

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

• Registration Number: NCT04903184
• Lead Sponsor: RUTI Immunotherapeutics S.L.

Brief Summary

The aim of this study is to explore potential for reduction of incidence and/or morbidity of SARS-CoV-2 infection in healthcare personnel. The study will include a comparison between placebo and RUTI® vaccine in a 2:1 design.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-06
• Study First Submitted: 2021-05-21
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-26
• Primary Completion: 2021-11-11
• Study Completion: 2021-11-11
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

1. Sign the Informed Consent before initiating the selection procedures.

2. Population:

   1. Healthcare system workers working in contact with subjects potentially infected with SARS-CoV-2
   2. People between 18 years and 59 years

3. Willingness to meet the requirements of the protocol.

4. Negative Rapid Serological Test of SARS-CoV-2

5. 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:

   • Subjects with human immunodeficiency virus (HIV-1).
   • Neutropenic subjects with less than 500 neutrophils / mm3.
   • Subjects with solid organ transplantation.
   • Subjects with bone marrow transplantation.
   • Subjects undergoing chemotherapy.
   • Subjects with primary immunodeficiency.
   • Severe lymphopenia with less than 400 lymphocytes / mm3.

9. Malignancy, or active solid or non-solid lymphoma from the previous two years.

10. Soy allergy.

11. Direct involvement in the design or execution of the RUTICOVID19 clinical trial.

12. 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.

13. Do not have a smartphone.

14. Detection by the researcher of lack of knowledge or willingness to participate and comply with all requirements of the protocol.

15. 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
Group RUTI	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.
Group 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.

Primary Outcome Measures

Name	Time	Method
Documented cumulative incidence of SARS-CoV-2 infection	6 months	Percent of 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
Fever	6 months	Number of days of self-reported fever (≥38 ºC)
Incidence of mechanical ventilation	6 months	Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection
Incidence of death from SARS-CoV-2 infection	6 months	Cumulative incidence of death from documented SARS-CoV-2 infection
Incidence of hospital admissions	6 months	Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection
Sick leave for SARS-CoV-2	6 months	Number of days of documented sick leave for SARS-CoV-2
Days off work due to the quarantine	6 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
Days of hospitalization	6 months	Number of days of hospitalization for documented SARS-CoV-2 infection
Incidence of SARS-CoV-2 antibodies	Study completion, an average of 1 year	Incidence of SARS-CoV-2 antibodies at the end of the study period
Levels of SARS-CoV-2 antibodies	Study completion, an average of 1 year	Levels of SARS-CoV-2 antibodies
Quarantine imposed by close contact outside the center with SARS-CoV-2 positive	6 months	Number of days of quarantine imposed by close contact outside the center with SARS-CoV-2 positive
Incidence of self-reported acute respiratory symptoms	6 months	Cumulative incidence of self-reported acute respiratory symptoms
Days in ICU	6 months	Number of days admitted to the ICU for documented SARS-CoV-2 infection
Types of antibodies detected	Study completion, an average of 1 year	Frequency of immunoglobulin IgG and immunoglobulin IgM
Days of self-reported acute respiratory symptoms	6 months	Number of days of self-reported acute respiratory symptoms
Incidence of pneumonia	6 months	Presence of compatible symptoms and radiological or tomographic focal alteration in the context of a confirmed diagnosis of Covid-19 infection and without evidence of other concomitant pathologies
Incidence of admissions to Intensive Care Unit (ICU)	6 months	Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection

Trial Locations

Locations (6)

Hospital General de Agudos Dr. Ignacio Pirovano; 🇦🇷 Buenos Aires, Argentina

Hospital Italiano de Buenos Aires; 🇦🇷 Buenos Aires, Argentina

Hospital General; 🇦🇷 Mendoza, Argentina

Hospital José Néstor Lencinas; 🇦🇷 Mendoza, Argentina

Hospital de Clínicas Presidente Dr. Nicolás Avellaneda; 🇦🇷 Tucumán, Argentina

Hospital Materno Infantil "Dr. Héctor Quintana"; 🇦🇷 San Salvador De Jujuy, Argentina