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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2020-12-15

Brief Summary

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

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Detailed Description

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* Evaluate the inhibition of the terminal glycosylation of the Enzyme Angiotensin II converter (ECE2).
* Check the inhibition of the main protease function (Mpro) of the SARS-CoV-2 agent by stable binding of the drug/protein to control viral replication.
* Check the oxidation reaction of the amine R-CH2-NH2 involved in the hyperactivation of macrophages (immune system innate), by interference of modified Isothymol.
* Evaluate the increase in tolerance to hypersensitivity of the immunoglobulins G (IgG) and immunoglobulins M (IgM) in patients COVID-19.
* Check the suppression of production and adhesion of superoxides in neutrophils (Immunostimulatory effect) through the regulation of cytokines and IL-6 (interleukins) for the inhibition of cytokine storm (Stage 2 and 3, infected patient).

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Isothymol or Carvacrol group

* 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%).

Group Type EXPERIMENTAL

Carvacrol

Intervention Type DRUG

Carvativir 6 mg/ml diluted for oral solution.

Control

•Placebo

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type OTHER

Placebo

Interventions

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Carvacrol

Carvativir 6 mg/ml diluted for oral solution.

Intervention Type DRUG

Control group

Placebo

Intervention Type OTHER

Other Intervention Names

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CARVATIVIR

Eligibility Criteria

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Inclusion Criteria

A sample size of 600 patients is expected, which must be randomize for parallel administration of experimental drug (300 patients) and placebo (300 patients).

It should be evaluated prior to the start of the clinical trial: Tests of rapid diagnosis (PDR test), chain reaction of the Reverse Transcriptase Polymerase (RT-PCR test), pressure blood pressure, pulse, temperature, body weight, blood tests, detection of autoimmune and infectious diseases (HIV, lupus, rheumatoid arthritis, hepatitis, syphilis), detection of antibodies (immunoglobulin G and immunoglobulin and M), urine tests for detect drugs and pregnancy (in the case of women) and other comorbid conditions characterized. In addition, chest x-ray should be performed on each patient included in the test, and if possible perform a computerized tomography (before and after treatment with modified Isothymol).

There will be an electronic system to load all the variables scientific and clinical protocol established in data collection, and will also allow processing of expedited output variables, which can be audited in real time.

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

Exclusion Criteria

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No