Clinical trial NCT04453488: Clinical Trial to Evaluate the Efficacy of RUTI® Against SARS-COV-2 Infection (COVID-19) in Healthcare Workers
Official title: Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of the RUTI® Vaccine to Prevent SARS-CoV-2 Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Covid-19
Sars-CoV2
Lead sponsor: Fundació Institut Germans Trias i Pujol
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 315
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 purpose of this study is to assess the efficacy of RUTI® vaccine preventing SARS-CoV-2 infection (COVID-19) in healthcare workers.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Documented cumulative incidence of SARS-CoV-2 infection
timeFrame: Up to 4 months
Secondary outcomes:
measure: Sick leave for SARS-CoV-2
timeFrame: Up to 4 months
measure: Days off work due to the quarantine
timeFrame: Up to 4 months
measure: Quarantine imposed by close contact outside the center with SARS-CoV-2 positive
timeFrame: Up to 4 months
measure: Professional category
timeFrame: Up to 4 months
measure: Fever
timeFrame: Up to 4 months
measure: Incidence of self-reported acute respiratory symptoms
timeFrame: Up to 4 months
measure: Days of self-reported acute respiratory symptoms
timeFrame: Up to 4 months
measure: Incidence of pneumonia
timeFrame: Up to 4 months
measure: Incidence of death from SARS-CoV-2 infection
timeFrame: Up to 4 months
measure: Incidence of admissions to Intensive Care Unit (ICU)
timeFrame: Up to 4 months
measure: Days in ICU
timeFrame: Up to 4 months
measure: Incidence of mechanical ventilation
timeFrame: Up to 4 months
measure: Incidence of hospital admissions
timeFrame: Up to 4 months
measure: Days of hospitalization
timeFrame: Up to 4 months
measure: Incidence of SARS-CoV-2 antibodies
timeFrame: Final visit
measure: Types of antibodies detected
timeFrame: Final visit
measure: Levels of SARS-CoV-2 antibodies
timeFrame: Final visit
Other outcomes:
measure: AEs
timeFrame: Up to 4 months
measure: SAEs
timeFrame: Up to 4 months
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol UBP Riscos Laborals
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: IGTP
name: Pere-Joan Cardona, MD, PhD
role: STUDY_CHAIR
References: