Clinical trial NCT04903184: Exploratory Study to Evaluate the Efficacy of RUTI® Against SARS-COV-2 Infection (COVID-19) in Healthcare Workers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid-19
Lead sponsor: RUTI Immunotherapeutics S.L.
Sponsor class: INDUSTRY
First posted: 2021-05-26
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Documented cumulative incidence of SARS-CoV-2 infection
timeFrame: 6 months
Secondary outcomes:
measure: Sick leave for SARS-CoV-2
timeFrame: 6 months
measure: Days off work due to the quarantine
timeFrame: 6 months
measure: Quarantine imposed by close contact outside the center with SARS-CoV-2 positive
timeFrame: 6 months
measure: Fever
timeFrame: 6 months
measure: Incidence of self-reported acute respiratory symptoms
timeFrame: 6 months
measure: Days of self-reported acute respiratory symptoms
timeFrame: 6 months
measure: Incidence of pneumonia
timeFrame: 6 months
measure: Incidence of death from SARS-CoV-2 infection
timeFrame: 6 months
measure: Incidence of admissions to Intensive Care Unit (ICU)
timeFrame: 6 months
measure: Days in ICU
timeFrame: 6 months
measure: Incidence of mechanical ventilation
timeFrame: 6 months
measure: Incidence of hospital admissions
timeFrame: 6 months
measure: Days of hospitalization
timeFrame: 6 months
measure: Incidence of SARS-CoV-2 antibodies
timeFrame: Study completion, an average of 1 year
measure: Types of antibodies detected
timeFrame: Study completion, an average of 1 year
measure: Levels of SARS-CoV-2 antibodies
timeFrame: Study completion, an average of 1 year
Other outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 6 months
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos Dr. Ignacio Pirovano
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Mendoza
country: Argentina
facility: Hospital General
city: Mendoza
country: Argentina
facility: Hospital José Néstor Lencinas
city: San Salvador De Jujuy
country: Argentina
facility: Hospital Materno Infantil "Dr. Héctor Quintana"
city: Tucumán
country: Argentina
facility: Hospital de Clínicas Presidente Dr. Nicolás Avellaneda
Study officials:
References: