• Check the efficacy, safety and tolerability of the compound Modified isothymol against the SARS-CoV-2 agent in patients COVID-19.
* 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
600
Carvativir 6 mg/ml diluted for oral solution.
Placebo
Hospital Dr. Leopoldo Manrique Terrero - Periférico de Coche.
Caracas, Miranda, Venezuela
Mortality Rate Among COVID-19 Patients
The incidence of mortality in the first 15 days.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Day 1 to Day 15
Longitudinal Assessment of Viral Load by Semi-Quantitative Polymerase Chain Reaction (PCR) Over Time to Day 15
Ribonucleic acid (RNA) from the nasal swab will be used to assess SARS-CoV-2 viral load.
Time frame: Day 1 to Day 15
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