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

Phase 2

Completed

• Conditions: COVID-19 Acute Respiratory Distress Syndrome; COVID-19 Respiratory Infection; COVID-19 Pneumonia; COVID-19 Lower Respiratory Infection; COVID-19
• Interventions: Other: Control group; Drug: Carvacrol

• Registration Number: NCT05445089
• Lead Sponsor: Instituto Venezolano de Investigaciones Cientificas

Brief Summary

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

Detailed Description

* 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).

Study Timeline

• Study Start: 2020-08-01
• Primary Completion: 2020-11-01
• Study Completion: 2020-12-15
• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-05
• Study First Posted: 2022-07-06
• Last Update Posted: 2022-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control group	•Placebo
Isothymol or Carvacrol group	Carvacrol	* 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%).

Primary Outcome Measures

Name	Time	Method
Mortality Rate Among COVID-19 Patients	Day 1 to Day 15	The incidence of mortality in the first 15 days.
Requirement for Extracorporeal Membrane Oxygenation (ECMO) in COVID-19 Patients Over Time to Day 15	Day 1 to Day 15	A measure of disease morbidity.
Quantitative Evaluation of Inflammatory Mediator Interleukin 6 (IL-6) by test ELISA as Collected Over Time to Day 15	Day 1 to Day 15	Interleukin 6 (IL-6) in pg/ml
Quantitative Evaluation of Immunoglobulin M (IgM) by test ELISA as Collected Over Time to Day 15	Day 1 to Day 15	IgM in mg/dl
Quantitative Evaluation of Immunoglobulin G (IgG) by test ELISA as Collected Over Time to Day 15	Day 1 to Day 15	IgG in mg/dl
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	Day 1 to Day 15	As a measure of disease acuity and severity.

Secondary Outcome Measures

Name	Time	Method
Longitudinal Assessment of Viral Load by Semi-Quantitative Polymerase Chain Reaction (PCR) Over Time to Day 15	Day 1 to Day 15	Ribonucleic acid (RNA) from the nasal swab will be used to assess SARS-CoV-2 viral load.

Trial Locations

Locations (1)

Hospital Dr. Leopoldo Manrique Terrero - Periférico de Coche.; 🇻🇪 Caracas, Miranda, Venezuela