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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Mortality Rate Among COVID-19 Patients
研究概览
简要总结
• Check the efficacy, safety and tolerability of the compound Modified isothymol against the SARS-CoV-2 agent in patients COVID-19.
详细描述
- 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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%).
干预措施: Carvacrol (Drug)
Control
•Placebo
干预措施: Control group (Other)
结局指标
主要结局
Mortality Rate Among COVID-19 Patients
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Day 1 to Day 15
As a measure of disease acuity and severity.
次要结局
- Longitudinal Assessment of Viral Load by Semi-Quantitative Polymerase Chain Reaction (PCR) Over Time to Day 15(Day 1 to Day 15)
研究者
Raul Antonio Ojeda Rondon
Principal Investigator
Instituto Venezolano de Investigaciones Cientificas