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Covid-19Phase 2NCT04903184

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

A Phase 2 study testing RUTI® vaccine in people with Covid-19, run by RUTI Immunotherapeutics S.L. at 6 sites in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Covid-19
What is being tested?
RUTI® vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
251 participants
Where
6 sitesArgentina
Study dates
6 Jan 2021to 11 Nov 2021
Phase
Phase 2
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.
  • Population:
  • Healthcare system workers working in contact with subjects potentially infected with SARS-CoV-2
  • People between 18 years and 59 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.
Show all 22Show fewer
  • 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.
  • Malignancy, or active solid or non-solid lymphoma from the previous two years.
  • Soy allergy.
  • Direct involvement in the design or execution of the RUTICOVID19 clinical trial.
  • 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.
  • Do not have a smartphone.
  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Argentina6 sites

  • Hospital General de Agudos Dr. Ignacio Pirovano

    Buenos Aires

  • Hospital Italiano de Buenos Aires

    Buenos Aires

  • Hospital General

    Mendoza

  • Hospital José Néstor Lencinas

    Mendoza

  • Hospital de Clínicas Presidente Dr. Nicolás Avellaneda

    San Miguel de Tucumán

  • Hospital Materno Infantil "Dr. Héctor Quintana"

    San Salvador de Jujuy

Other trials in Argentina

About this study

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

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.

Conditions
Covid-19
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 in a total volum of 0,3mL.

  • PlaceboBiological

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

Study groups in NCT04903184
Study groupRoleWhat they receive
Group RUTIExperimentalParticipants 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
Group PlaceboPlacebo comparatorParticipants 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.

  1. 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

    Measured: 6 months

Secondary outcomes (16)

  1. Sick leave for SARS-CoV-2

    Number of days of documented sick leave for SARS-CoV-2

    Measured: 6 months

  2. 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: 6 months

  3. 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: 6 months

  4. Fever

    Number of days of self-reported fever (≥38 ºC)

    Measured: 6 months

  5. Incidence of self-reported acute respiratory symptoms

    Cumulative incidence of self-reported acute respiratory symptoms

    Measured: 6 months

  6. Days of self-reported acute respiratory symptoms

    Number of days of self-reported acute respiratory symptoms

    Measured: 6 months

  7. 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

    Measured: 6 months

  8. Incidence of death from SARS-CoV-2 infection

    Cumulative incidence of death from documented SARS-CoV-2 infection

    Measured: 6 months

  9. Incidence of admissions to Intensive Care Unit (ICU)

    Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection

    Measured: 6 months

  10. Days in ICU

    Number of days admitted to the ICU for documented SARS-CoV-2 infection

    Measured: 6 months

  11. Incidence of mechanical ventilation

    Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection

    Measured: 6 months

  12. Incidence of hospital admissions

    Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection

    Measured: 6 months

  13. Days of hospitalization

    Number of days of hospitalization for documented SARS-CoV-2 infection

    Measured: 6 months

  14. Incidence of SARS-CoV-2 antibodies

    Incidence of SARS-CoV-2 antibodies at the end of the study period

    Measured: Study completion, an average of 1 year

  15. Types of antibodies detected

    Frequency of immunoglobulin IgG and immunoglobulin IgM

    Measured: Study completion, an average of 1 year

  16. Levels of SARS-CoV-2 antibodies

    Levels of SARS-CoV-2 antibodies

    Measured: Study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2021
  2. Study start6 Jan 2021
  3. Primary completion11 Nov 2021
  4. Study completion11 Nov 2021

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
251 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04903184
Sponsor's protocol ID
RUTICOVID19-ARG
Status last verified
Jan 2023
First submitted
21 May 2021
Last updated
26 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RUTI® vaccine in people with Covid-19, run by RUTI Immunotherapeutics S.L. at 6 sites in Argentina.

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 7 inclusion and 22 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: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Argentina. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Documented cumulative incidence of SARS-CoV-2 infection (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04903184.

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 26 Jan 2023.

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