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

NCT05115019 | Withdrawn Phase 2

• 1 other identifier: MYCOVIND
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (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

  1 month

Secondary Outcomes (11)

• Fever

  1 month

• Incidence of acute respiratory symptoms

  1 month

• Patient rate reduction C1 or lower (WHO scale)

  1 month

• Incidence of death by SARS-CoV

  1 month

• Incidence admission at Intensive Care Unit

  1 month

Study Arms (2)

Group A (RUTI)

EXPERIMENTAL

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

Biological: RUTI® vaccine

Group B (Placebo)

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

RUTI® vaccine BIOLOGICAL

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.

Group A (RUTI)

Placebo BIOLOGICAL

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

Group B (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• PT. Innovative Pharma Solutions: lead
• Archivel Farma S.L.: collaborator
• RUTI Immunotherapeutics S.L.: collaborator

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 10, 2021
• Study Start: December 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: April 1, 2022
• Last Updated: February 10, 2023

Record last verified: 2023-02