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

Primary Purpose

COVID-19

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
RUTI® vaccine
Placebo
Sponsored by
PT. Innovative Pharma Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Sign the Informed Consent before initiating the selection procedures.
  2. 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.
  3. People ≥ 18 years.
  4. Peripheral oxygen saturation (SpO2) more than 94% on room air, not requiring supplemental oxygen.
  5. Availability to meet the requirements of the protocol.

Exclusion Criteria:

  1. Pregnancy or breastfeeding.
  2. Suspected of active viral or bacterial infection other than SARS-CoV-2.
  3. Participation in another interventional study with potentially conflicting medication within 30 days before screening.
  4. Severely immunocompromised people (data gathered from preexisting medical records and history taking). 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.
  5. Malignancy, or active solid or non-solid lymphoma from the previous two years.
  6. BCG vaccination in the last 10 years.
  7. Chloroquine or hydroxychloroquine administration in the last two weeks
  8. Soy allergy
  9. Direct involvement in the design or execution of the MYCOVIND clinical trial.
  10. Do not have a smartphone.
  11. Detection by the investigator of lack of knowledge or willingness to participate and comply with all requirements of the protocol.
  12. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Group A (RUTI)

    Group B (Placebo)

    Arm Description

    Participants 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

    Participants will receive one dose of sterile physiological serum at the baseline visit, which will be administered subcutaneously in the deltoid region.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Fever
    Number of days with fever (≥38 ºC).
    Incidence of acute respiratory symptoms
    Number of acute respiratory symptoms (SpO2 < 95%)
    Patient rate reduction C1 or lower (WHO scale)
    Reduction patient rate to category 1 or lower according to the WHO Ordinal scale
    Incidence of death by SARS-CoV
    Accumulated Incidence of death by SARS-CoV
    Incidence admission at Intensive Care Unit
    Accumulated incidence admission at Intensive Care Unit (documented)
    Days in Intensive Care Unit
    Number of days in Intensive Care Unit (documented)
    Incidence for mechanic ventilation due to SARS-CoV-2 infection
    Accumulated incidence for mechanic ventilation due to SARS-CoV-2 infection (documented)
    Days of mechanic ventilation due to SARS-CoV-2 infection
    Number of days of mechanic ventilation due to SARS-CoV-2 infection
    Days hospital admission due to SARS-CoV-2 infection
    Number of days hospital admission due to SARS-CoV-2 infection
    Incidence of Treatment-Emergent Adverse Events
    Proportion of patients reporting Adverse events (AEs, including serious adverse events)
    Levels of IgG SARS-CoV2
    Plasma SARS-CoV2 spike protein-specific IgG level

    Full Information

    First Posted
    November 9, 2021
    Last Updated
    February 8, 2023
    Sponsor
    PT. Innovative Pharma Solutions
    Collaborators
    Archivel Farma S.L., RUTI Immunotherapeutics S.L.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05115019
    Brief Title
    A Clinical Trial to Evaluate the Efficacy of RUTI® to Reduce the Severity of SARS-CoV-2 Infection (COVID-19)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Decrease of incidence and severity of COVID and availability of therapeutic alternatives
    Study Start Date
    December 2021 (Anticipated)
    Primary Completion Date
    February 2022 (Anticipated)
    Study Completion Date
    April 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    PT. Innovative Pharma Solutions
    Collaborators
    Archivel Farma S.L., RUTI Immunotherapeutics S.L.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A (RUTI)
    Arm Type
    Experimental
    Arm Description
    Participants 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
    Arm Title
    Group B (Placebo)
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will receive one dose of sterile physiological serum at the baseline visit, which will be administered subcutaneously in the deltoid region.
    Intervention Type
    Biological
    Intervention Name(s)
    RUTI® vaccine
    Intervention Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo
    Intervention Description
    Physiological serum, 0.9% NaCl, will be used as a placebo
    Primary Outcome Measure Information:
    Title
    Reduction patient rate to category 0 according to the WHO Ordinal scale by Day 30 after the initiation of vaccination
    Description
    Reduction patient rate to category 0 according to the WHO Ordinal scale by Day 30 after the initiation of vaccination
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Fever
    Description
    Number of days with fever (≥38 ºC).
    Time Frame
    1 month
    Title
    Incidence of acute respiratory symptoms
    Description
    Number of acute respiratory symptoms (SpO2 < 95%)
    Time Frame
    1 month
    Title
    Patient rate reduction C1 or lower (WHO scale)
    Description
    Reduction patient rate to category 1 or lower according to the WHO Ordinal scale
    Time Frame
    1 month
    Title
    Incidence of death by SARS-CoV
    Description
    Accumulated Incidence of death by SARS-CoV
    Time Frame
    1 month
    Title
    Incidence admission at Intensive Care Unit
    Description
    Accumulated incidence admission at Intensive Care Unit (documented)
    Time Frame
    1 month
    Title
    Days in Intensive Care Unit
    Description
    Number of days in Intensive Care Unit (documented)
    Time Frame
    1 month
    Title
    Incidence for mechanic ventilation due to SARS-CoV-2 infection
    Description
    Accumulated incidence for mechanic ventilation due to SARS-CoV-2 infection (documented)
    Time Frame
    1 month
    Title
    Days of mechanic ventilation due to SARS-CoV-2 infection
    Description
    Number of days of mechanic ventilation due to SARS-CoV-2 infection
    Time Frame
    1 month
    Title
    Days hospital admission due to SARS-CoV-2 infection
    Description
    Number of days hospital admission due to SARS-CoV-2 infection
    Time Frame
    1 month
    Title
    Incidence of Treatment-Emergent Adverse Events
    Description
    Proportion of patients reporting Adverse events (AEs, including serious adverse events)
    Time Frame
    1 month
    Title
    Levels of IgG SARS-CoV2
    Description
    Plasma SARS-CoV2 spike protein-specific IgG level
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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