Covid-19Phase 3NCT04453488
Clinical Trial to Evaluate the Efficacy of RUTI® Against SARS-COV-2 Infection (COVID-19) in Healthcare Workers
A Phase 3 study testing RUTI® vaccine in people with Covid-19 and Sars-CoV2, run by Fundació Institut Germans Trias i Pujol at 2 sites in Spain.
Trial summary
The purpose of this study is to assess the efficacy of RUTI® vaccine preventing SARS-CoV-2 infection (COVID-19) in healthcare workers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- RUTI® vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- 2 sitesSpain
- Study dates
- 30 Jul 2020to Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sign the Informed Consent before initiating the selection procedures.
- Healthcare system workers working in contact with subjects potentially infected with SARS-CoV-2.
- People ≥ 18 years.
- Willingness to meet the requirements of the protocol.
- Negative Rapid Serological Test of SARS-CoV-2
- The participant must agree to use effective contraceptive methods during the study period, in case of childbearing age.
Who cannot join
- Previous SARS-CoV-2 infection
- Pregnancy. Pregnancy test will be performed in case of doubt.
- Breastfeeding.
- Suspected of active viral or bacterial infection.
- Symptoms compatible with COVID-19, despite a negative polymerase chain reaction (PCR) test.
- Vaccination in the last 4 weeks or planned vaccination during the study period, except for influenza vaccine.
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- 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.
- 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.
- Treatment with any anti-cytokine therapy.
- Oral treatment with steroids, defined as daily doses of 10 mg prednisone or equivalent for more than 3 months.
- Malignancy, or active solid or non-solid lymphoma from the previous two years.
- BCG vaccination in the last 1year.
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitari Germans Trias i Pujol UBP Riscos Laborals
Badalona, Barcelona, 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
About this study
Official title: Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of the RUTI® Vaccine to Prevent SARS-CoV-2 Infection
The purpose of this study is to assess the efficacy of RUTI® vaccine preventing SARS-CoV-2 infection (COVID-19) in healthcare workers.
Read the 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.
- Being tested
- RUTI® vaccine, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RUTI® vaccineBiological
Each dose of the RUTI® vaccine contains 25 µg of fragmented, purified and liposomed heat-inactivated Mycobacterium tuberculosis bacilli.
PlaceboBiological
Physiological serum, 0.9% NaCl, will be used as a placebo
| Study group | Role | What they receive |
|---|---|---|
| RUTI® vaccine | Experimental | 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. Receives: Biological: RUTI® vaccine |
| Placebo | Placebo comparator | 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. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documented cumulative incidence of SARS-CoV-2 infection
% positive serology at the end of the study or positive PCR test in the course of routine clinical practice
Measured: Up to 4 months
Secondary outcomes (17)
Sick leave for SARS-CoV-2
Number of days of documented sick leave for SARS-CoV-2
Measured: Up to 4 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
Measured: Up to 4 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
Measured: Up to 4 months
Professional category
Number of MD, nursing, personnel management and services, etc.
Measured: Up to 4 months
Fever
Number of days of self-reported fever (≥38 ºC)
Measured: Up to 4 months
Incidence of self-reported acute respiratory symptoms
Cumulative incidence of self-reported acute respiratory symptoms
Measured: Up to 4 months
Days of self-reported acute respiratory symptoms
Number of days of self-reported acute respiratory symptoms
Measured: Up to 4 months
Incidence of pneumonia
Number of participants with pneumonia confirmed by X-ray
Measured: Up to 4 months
Incidence of death from SARS-CoV-2 infection
Cumulative incidence of death from documented SARS-CoV-2 infection
Measured: Up to 4 months
Incidence of admissions to Intensive Care Unit (ICU)
Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection
Measured: Up to 4 months
Days in ICU
Number of days admitted to the ICU for documented SARS-CoV-2 infection
Measured: Up to 4 months
Incidence of mechanical ventilation
Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection
Measured: Up to 4 months
Incidence of hospital admissions
Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection
Measured: Up to 4 months
Days of hospitalization
Number of days of hospitalization for documented SARS-CoV-2 infection
Measured: Up to 4 months
Incidence of SARS-CoV-2 antibodies
Incidence of SARS-CoV-2 antibodies at the end of the study period
Measured: Final visit
Types of antibodies detected
Frequency and levels of immunoglobulin IgG and immunoglobulin IgM
Measured: Final visit
Levels of SARS-CoV-2 antibodies
Levels of SARS-CoV-2 antibodies at the end of the study period
Measured: Final visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start30 Jul 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut Germans Trias i Pujol
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pere-Joan Cardona, MD, PhD, Study chair, IGTP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453488
- Sponsor's protocol ID
- RUTICOVID19
- Status last verified
- Jul 2020
- First submitted
- 30 Jun 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of the RUTI® Vaccine to Prevent SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04453488
- Acronym / sponsor ID
- RUTICOVID19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Fundació Institut Germans Trias i PujolUniversity, hospital or other
- Study start
- 30 Jul 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RUTI® vaccine | Experimental | Biological: RUTI® vaccineParticipants 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. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Sign the Informed Consent before initiating the selection procedures.
- Healthcare system workers working in contact with subjects potentially infected with SARS-CoV-2.
- People ≥ 18 years.
- Willingness to meet the requirements of the protocol.
- Negative Rapid Serological Test of SARS-CoV-2
Key exclusion criteria (27 listed)
- Previous SARS-CoV-2 infection
- Pregnancy. Pregnancy test will be performed in case of doubt.
- Breastfeeding.
- Suspected of active viral or bacterial infection.
- Symptoms compatible with COVID-19, despite a negative polymerase chain reaction (PCR) test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RUTI® vaccineEach dose of the RUTI® vaccine contains 25 µg of fragmented, purified and liposomed heat-inactivated Mycobacterium tuberculosis bacilli. | Biological | RUTI® vaccine |
| PlaceboPhysiological serum, 0.9% NaCl, will be used as a placebo | Biological | Placebo |
Primary outcome
Documented cumulative incidence of SARS-CoV-2 infection
Time frame: Up to 4 months
% positive serology at the end of the study or positive PCR test in the course of routine clinical practice
17 secondary outcomes
Sick leave for SARS-CoV-2
Time frame: Up to 4 months
Days off work due to the quarantine
Time frame: Up to 4 months
Quarantine imposed by close contact outside the center with SARS-CoV-2 positive
Time frame: Up to 4 months
Professional category
Time frame: Up to 4 months
Fever
Time frame: Up to 4 months
Incidence of self-reported acute respiratory symptoms
Time frame: Up to 4 months
Days of self-reported acute respiratory symptoms
Time frame: Up to 4 months
Incidence of pneumonia
Time frame: Up to 4 months
Incidence of death from SARS-CoV-2 infection
Time frame: Up to 4 months
Incidence of admissions to Intensive Care Unit (ICU)
Time frame: Up to 4 months
Days in ICU
Time frame: Up to 4 months
Incidence of mechanical ventilation
Time frame: Up to 4 months
Incidence of hospital admissions
Time frame: Up to 4 months
Days of hospitalization
Time frame: Up to 4 months
Incidence of SARS-CoV-2 antibodies
Time frame: Final visit
Types of antibodies detected
Time frame: Final visit
Levels of SARS-CoV-2 antibodies
Time frame: Final visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pere-Joan Cardona, MD, PhD study chair
IGTP
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RUTI® vaccine in people with Covid-19 and Sars-CoV2, run by Fundació Institut Germans Trias i Pujol at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pere-Joan Cardona, MD, PhD (+34 93 033 0527 ext. 6400, pjcardona@igtp.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Documented cumulative incidence of SARS-CoV-2 infection (time frame: Up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.