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

Covid-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04903184
• Other study ID #: RUTICOVID19-ARG
• Status: Completed
• Phase: Phase 2
• Start date: January 6, 2021
• Est. completion date: November 11, 2021

Study information

• Verified date: January 2023
• Source: RUTI Immunotherapeutics S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: November 11, 2021
• Est. primary completion date: November 11, 2021
• 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. 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.

Related Conditions & MeSH terms

• Covid-19

Intervention

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
Physiological serum, 0.9% NaCl, will be used as a placebo.

Locations

Country	Name	City	State
Argentina	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 Materno Infantil "Dr. Héctor Quintana"	San Salvador De Jujuy
Argentina	Hospital de Clínicas Presidente Dr. Nicolás Avellaneda	Tucumán

Sponsors (1)

Lead Sponsor	Collaborator
RUTI Immunotherapeutics S.L.

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Sick leave for SARS-CoV-2	Number of days of documented sick leave for SARS-CoV-2	6 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	6 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	6 months
Secondary	Fever	Number of days of self-reported fever (=38 ºC)	6 months
Secondary	Incidence of self-reported acute respiratory symptoms	Cumulative incidence of self-reported acute respiratory symptoms	6 months
Secondary	Days of self-reported acute respiratory symptoms	Number of days of self-reported acute respiratory symptoms	6 months
Secondary	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
Secondary	Incidence of death from SARS-CoV-2 infection	Cumulative incidence of death from documented SARS-CoV-2 infection	6 months
Secondary	Incidence of admissions to Intensive Care Unit (ICU)	Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection	6 months
Secondary	Days in ICU	Number of days admitted to the ICU for documented SARS-CoV-2 infection	6 months
Secondary	Incidence of mechanical ventilation	Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection	6 months
Secondary	Incidence of hospital admissions	Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection	6 months
Secondary	Days of hospitalization	Number of days of hospitalization for documented SARS-CoV-2 infection	6 months
Secondary	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
Secondary	Types of antibodies detected	Frequency of immunoglobulin IgG and immunoglobulin IgM	Study completion, an average of 1 year
Secondary	Levels of SARS-CoV-2 antibodies	Levels of SARS-CoV-2 antibodies	Study completion, an average of 1 year