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COVID-19Phase 2/3NCT05115019

A Clinical Trial to Evaluate the Efficacy of RUTI® to Reduce the Severity of SARS-CoV-2 Infection (COVID-19)

A Phase 2/3 study testing RUTI® vaccine in people with COVID-19, run by PT. Innovative Pharma Solutions.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The aim of this study is to assess the efficacy of the RUTI® vaccine in achieving clinical improvement of COVID-19 symptoms and to evaluate the safety of RUTI® in patients with SARS-CoV-2 infection. The study will include a comparison between placebo and RUTI® vaccine in a 1:1 design. Read more about this study

Who is it for?
Ages 18 years and older
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
0 participants
Where
No sites listed yet
Study dates
Dec 2021to Apr 2022
Phase
Phase 2/3
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign the Informed Consent before initiating the selection procedures.
  • Patients infected with SARS-CoV-2 (PCR +) with mild symptoms up to 7 days that do not require hospitalization, from the onset of symptoms. Mild symptoms, defined as the following criteria: cough, headache, fever (>37.5ºC), muscular pain and shortness of breath.
  • People ≥ 18 years.
  • Peripheral oxygen saturation (SpO2) more than 94% on room air, not requiring supplemental oxygen.
  • Availability to meet the requirements of the protocol.

Who cannot join

  • Pregnancy or breastfeeding.
  • Suspected of active viral or bacterial infection other than SARS-CoV-2.
  • Participation in another interventional study with potentially conflicting medication within 30 days before screening.
  • Severely immunocompromised people (data gathered from preexisting medical records and history taking). This exclusion category includes:
  • Subjects with human immunodeficiency virus (HIV-1).
  • Neutropenic subjects with less than 500 neutrophils / mm3.
Show all 21Show fewer
  • 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 10 years.
  • Chloroquine or hydroxychloroquine administration in the last two weeks
  • Soy allergy
  • Direct involvement in the design or execution of the MYCOVIND clinical trial.
  • Do not have a smartphone.
  • Detection by the investigator of lack of knowledge or willingness to participate and comply with all requirements of the protocol.
  • Any other findings that, at the discretion of the investigator, may compromise compliance with the protocol or that may influence significantly the interpretation or the results of the effects of probiotics.

About this study

Official title: A Phase II/III, Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of RUTI® to Reduce the Severity of SARS-CoV-2 Infection

The aim of this study is to assess the efficacy of the RUTI® vaccine in achieving clinical improvement of COVID-19 symptoms and to evaluate the safety of RUTI® in patients with SARS-CoV-2 infection. The study will include a comparison between placebo and RUTI® vaccine in a 1:1 design.

Read the detailed description

Once it has been confirmed that the patient meets the selection criteria, subjects will be randomly assigned to one of the two study groups:

  • Experimental group: Administration of RUTI®
  • Control group: Administration of Placebo (physiological serum)

This randomization follows a 1:1 ratio. In this way, of the total of 550 subjects who intend to be recruited for this study, 275 will receive the prophylactic treatment, and 275 will receive the placebo treatment.

Neither patient nor the doctor will know if the subject is part of the experimental group or the control group, that is to say, the treatment assignment is blind.

All subjets will receive just one inoculation of treatment (either RUTI® or Pacebo). The standard treatment of COVID-19, if is necessary, will continue after RUTI® administration according to the local guidelines.

All the subjets will be followed for one month after the first day of RUTI® or Placebo treatment.

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 (FCMtb) in a total volum of 0.3mL.

  • PlaceboBiological

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

Study groups in NCT05115019
Study groupRoleWhat they receive
Group A (RUTI)ExperimentalParticipants will receive one dose of RUTI® vaccine at the baseline visit, 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 (FCMtb) in an injection volume of 0.3 m
Receives: Biological: RUTI® vaccine
Group B (Placebo)Placebo comparatorParticipants will receive one dose of sterile physiological serum at the baseline visit, which will be administered subcutaneously in the deltoid region.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction patient rate to category 0 according to the WHO Ordinal scale by Day 30 after the initiation of vaccination

    Reduction patient rate to category 0 according to the WHO Ordinal scale by Day 30 after the initiation of vaccination

    Measured: 1 month

Secondary outcomes (11)

  1. Fever

    Number of days with fever (≥38 ºC).

    Measured: 1 month

  2. Incidence of acute respiratory symptoms

    Number of acute respiratory symptoms (SpO2 < 95%)

    Measured: 1 month

  3. Patient rate reduction C1 or lower (WHO scale)

    Reduction patient rate to category 1 or lower according to the WHO Ordinal scale

    Measured: 1 month

  4. Incidence of death by SARS-CoV

    Accumulated Incidence of death by SARS-CoV

    Measured: 1 month

  5. Incidence admission at Intensive Care Unit

    Accumulated incidence admission at Intensive Care Unit (documented)

    Measured: 1 month

  6. Days in Intensive Care Unit

    Number of days in Intensive Care Unit (documented)

    Measured: 1 month

  7. Incidence for mechanic ventilation due to SARS-CoV-2 infection

    Accumulated incidence for mechanic ventilation due to SARS-CoV-2 infection (documented)

    Measured: 1 month

  8. Days of mechanic ventilation due to SARS-CoV-2 infection

    Number of days of mechanic ventilation due to SARS-CoV-2 infection

    Measured: 1 month

  9. Days hospital admission due to SARS-CoV-2 infection

    Number of days hospital admission due to SARS-CoV-2 infection

    Measured: 1 month

  10. Incidence of Treatment-Emergent Adverse Events

    Proportion of patients reporting Adverse events (AEs, including serious adverse events)

    Measured: 1 month

  11. Levels of IgG SARS-CoV2

    Plasma SARS-CoV2 spike protein-specific IgG level

    Measured: 1 month

Timeline

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

  1. First posted10 Nov 2021
  2. Study startDec 2021 (estimated)
  3. Primary completionFeb 2022 (estimated)
  4. Study completionApr 2022 (estimated)

Why it stopped: Decrease of incidence and severity of COVID and availability of therapeutic alternatives

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05115019
Sponsor's protocol ID
MYCOVIND
Status last verified
Feb 2023
First submitted
9 Nov 2021
Last updated
10 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing RUTI® vaccine in people with COVID-19, run by PT. Innovative Pharma Solutions.

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 5 inclusion and 21 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: withdrawn, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Reduction patient rate to category 0 according to the WHO Ordinal scale by Day 30 after the initiation of vaccination (time frame: 1 month). 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 NCT05115019.

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 10 Feb 2023.

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