NCT05445089

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

Multicenter, Randomized, Double-blind Study With Placebo to Verify the Efficacy, Safety and Tolerability of the Modified Isothymol or Carvacrol Compound Against the SARS-CoV-2 Agent in COVID-19 Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Instituto Venezolano de Investigaciones Cientificas · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
DRUG	Carvacrol	Carvativir 6 mg/ml diluted for oral solution.
OTHER	Control group	Placebo

Timeline

• Start date: 2020-08-01
• Primary completion: 2020-11-01
• Completion: 2020-12-15
• First posted: 2022-07-06
• Last updated: 2022-07-08

Locations

1 site across 1 country: Venezuela