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Withdrawn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

About this trial
This is an interventional treatment trial for COVID-19
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.
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
NCT ID
NCT05115019
First Posted
November 9, 2021
Last Updated
February 8, 2023
Sponsor
PT. Innovative Pharma Solutions
Collaborators
Archivel Farma S.L., RUTI Immunotherapeutics S.L.
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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