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

A Exploratory Phase II Clinical Trial, Double-blind, Randomized Placebo-controlled to Evaluate the Efficacy of RUTI® Against SARS-COV-2 Infection (COVID-19) in Healthcare Workers

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 251
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Hospital Italiano de Buenos Aires
  • Buenos Aires, Argentina
    • Hospital General de Agudos Dr. Ignacio Pirovano
  • Mendoza, Argentina
    • Hospital General
  • Mendoza, Argentina
    • Hospital José Nestor Lencinas
  • San Salvador De Jujuy, Argentina
    • Hospital Materno Infantil "Dr. Héctor Quintana"
  • Tucumán, Argentina
    • Hospital de Clínicas Presidente Dr. Nicolás Avellaneda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

16. 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 Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group RUTI; 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 in a total volum of 0,3mL.
Placebo Comparator: Group 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	Percent of positive serology at the end of the study or positive PCR test in the course of routine clinical practice	6 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	6 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	6 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	6 months
Fever	Number of days of self-reported fever (≥38 ºC)	6 months
Incidence of self-reported acute respiratory symptoms	Cumulative incidence of self-reported acute respiratory symptoms	6 months
Days of self-reported acute respiratory symptoms	Number of days of self-reported acute respiratory symptoms	6 months
Incidence of pneumonia	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	6 months
Incidence of death from SARS-CoV-2 infection	Cumulative incidence of death from documented SARS-CoV-2 infection	6 months
Incidence of admissions to Intensive Care Unit (ICU)	Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection	6 months
Days in ICU	Number of days admitted to the ICU for documented SARS-CoV-2 infection	6 months
Incidence of mechanical ventilation	Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection	6 months
Incidence of hospital admissions	Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection	6 months
Days of hospitalization	Number of days of hospitalization for documented SARS-CoV-2 infection	6 months
Incidence of SARS-CoV-2 antibodies	Incidence of SARS-CoV-2 antibodies at the end of the study period	Study completion, an average of 1 year
Types of antibodies detected	Frequency of immunoglobulin IgG and immunoglobulin IgM	Study completion, an average of 1 year
Levels of SARS-CoV-2 antibodies	Levels of SARS-CoV-2 antibodies	Study completion, an average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	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	6 months

Collaborators and Investigators

• Sponsor: RUTI Immunotherapeutics S.L.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Actual): November 11, 2021
• Study Completion (Actual): November 11, 2021

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

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-ARG

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