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

Phase 2

Withdrawn

• Conditions: COVID-19
• Interventions: Biological: Placebo; Biological: RUTI® vaccine

• Registration Number: NCT05115019
• Lead Sponsor: PT. Innovative Pharma Solutions

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.

Study Timeline

• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-10
• Study Start: 2021-12
• Primary Completion: 2022-02
• Study Completion: 2022-04
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (Placebo)	Placebo	Participants will receive one dose of sterile physiological serum at the baseline visit, which will be administered subcutaneously in the deltoid region.
Group A (RUTI)	RUTI® vaccine	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

Primary Outcome Measures

Name	Time	Method
Reduction patient rate to category 0 according to the WHO Ordinal scale by Day 30 after the initiation of vaccination	1 month	Reduction patient rate to category 0 according to the WHO Ordinal scale by Day 30 after the initiation of vaccination

Secondary Outcome Measures

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