Study to Verify the Effectiveness and Safety of Isothymol or Carvacrol Compound Against SARS-CoV-2 in COVID-19 Patients

NCT05445089 | Completed Phase 2 DMC

• 2 other identifiers: LAB-2020-01ISRCTN registry
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

• Check the efficacy, safety and tolerability of the compound Modified isothymol against the SARS-CoV-2 agent in patients COVID-19.

Conditions

COVID-19; COVID-19 Pneumonia; COVID-19 Respiratory Infection; COVID-19 Acute Respiratory Distress Syndrome; COVID-19 Lower Respiratory Infection

Keywords

SARS-CoV-2; Isothymol; Carvacrol; Antiviral; COVID-19; RNA; Cytokine storm

Outcome Measures

Primary Outcomes (6)

• Mortality Rate Among COVID-19 Patients

  The incidence of mortality in the first 15 days.

  Day 1 to Day 15

• Quantitative Evaluation of Inflammatory Mediator Interleukin 6 (IL-6) by test ELISA as Collected Over Time to Day 15

  Interleukin 6 (IL-6) in pg/ml

  Day 1 to Day 15

• Quantitative Evaluation of Immunoglobulin M (IgM) by test ELISA as Collected Over Time to Day 15

  IgM in mg/dl

  Day 1 to Day 15

• Quantitative Evaluation of Immunoglobulin G (IgG) by test ELISA as Collected Over Time to Day 15

  IgG in mg/dl

  Day 1 to Day 15

• Proportion of Patients with COVID-19 who Require Intensive Care Unit (ICU)-Level Care, Mechanical Ventilatory Support (MV), and/or Extracorporeal Membrane Oxygenation (ECMO) Over Time to Day 15

  As a measure of disease acuity and severity.

  Day 1 to Day 15

• Requirement for Extracorporeal Membrane Oxygenation (ECMO) in COVID-19 Patients Over Time to Day 15

  A measure of disease morbidity.

  Day 1 to Day 15

Secondary Outcomes (1)

• Longitudinal Assessment of Viral Load by Semi-Quantitative Polymerase Chain Reaction (PCR) Over Time to Day 15

  Day 1 to Day 15

Study Arms (2)

Isothymol or Carvacrol group

EXPERIMENTAL

* Each ml contains 6mg of Isothymol or Carvacrol (2-Methyl-5-(1-methylethyl)-phenol modified) at 1% v/v. (GRAS lipophilic modified with isothymol). * Oral solution (dispersion L/L). Dilute lipophilic aqueous solution of light or medium yellow. * Excipients: Cis-9-octadecenoic acid with Squalene (99%).

Drug: Carvacrol

Control

PLACEBO COMPARATOR

•Placebo

Other: Control group

Interventions

Carvacrol DRUG

Carvativir 6 mg/ml diluted for oral solution.

Also known as: CARVATIVIR

Isothymol or Carvacrol group

Control group OTHER

Placebo

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive test PDR, positive test RT-PCR, patients diagnosed with COVID-19
• Chest pain or other symptom consistent with bilateral pneumonia atypical, with one of the following paraclinical alterations and imaging:
• Oxygen saturation (SpO2) ≤93%.
• Elevation of D-dimer ≥10 mg/mL.
• Elevation of Ferritin ≥120 ng/mL.
• Elevation of Fibrinogen ≥400 mg/dL
• Elevation of Immunoglobulin M (IgM) ≥200 mg/dL.
• Elevation of Interleukin 6 (IL-6) ≥1800 pg/mL.
• Rx. chest and CT showing thickening of the bronchi, consolidation and ground glass opacities.

You may not qualify if:

• Negative test PDR, negative test RT-PCR and Inadequate administration of antiviral (for non-compliance with indicated intervals or death of the patient before 15 days treatment indications).

Sponsors & Collaborators

• Instituto Venezolano de Investigaciones Cientificas: lead

Study Sites (1)

Hospital Dr. Leopoldo Manrique Terrero - Periférico de Coche.

Caracas, Miranda, 1090, Venezuela

Location

Related Links

• Study to verify the effectiveness and safety of the modified isothymol or carvacrol compound against SARS-CoV-2 in COVID-19 patients

MeSH Terms

Conditions

COVID-19; Cytokine Release Syndrome

Interventions

carvacrol; Control Groups

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; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Raul Ojeda, MsC

  Biosynthesis Medical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The assigned treatment will not be known to the study subjects, the participating researchers and the evaluators of the criteria of study assessment. The placebo should contain the same technical specifications and physical appearance of modified Isothymol. To ensure individual opening of the randomization code, sealed envelopes will be prepared for each subject, which will contain the specific treatment received by each. These envelopes can be controlled by the Clinical Researcher, the Nursing Staff or Pharmacy available 24 hours. After obtaining informed consent, the treatment strategy uses centralized randomization, using a phone system. Eligible patients will be randomized to one of the following therapeutic strategies: * Modified Isothymol Treatment Group: Immediately after randomization a dose of 6 mg/ml of modified isothymol. * Placebo Treatment Group: Immediately after the randomization a placebo dose will be administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, double-blind, multicenter study with blind evaluation of events, designed to compare the efficacy and safety of Isothymol modified with placebo in patients ≥18 years of age who meet the inclusion criteria. * Drug administration scheme: Randomized and parallel (modified isothymol and placebo). * Statistical design: Superiority. It will allow to detect difference between drug and placebo after parallel administration.

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 6, 2022
• Study Start: August 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: December 15, 2020
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

VE (1)