Modulation of the Immune Response by AM3 Glycoconjugate.
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Lactato deshidrogenasa (LDH)
研究概览
简要总结
Introduction: In late 2019, a novel human coronavirus was detected in Wuhan, China, causing an outbreak of the severe acute respiratory syndrome - Coronavirus 2 (SARS-CoV-2). The disease that SARS-CoV-2 causes was named coronavirus disease 2019 (COVID-19). The virus rapidly spread throughout China and beyond, causing a public health challenge of global concern. Today, the availability of safe and effective drugs to treat COVID-19 remains limited, and symptomatic supportive treatments are the foundations of care. A natural glycophosphopeptical, AM3 has been shown to effectively improve the progression of infectious respiratory diseases with no side effects. In this context, AM3 could maintain an adequate immune status and serve as a therapeutic tool against COVID-19.
Study Aim: The effect of AM3 supplementation on the progression of COVID-19 patients. To evaluate the existence of significant differences between control and intervention groups in the progression of severe COVID-19 disease.
Methods: Double-blind randomized controlled clinical trial in collaboration with the Health Care Management of Soria. At the start of the trial, eligible patients will be randomized in a 1:1 ratio into two intervention and control groups. Block randomization with participants based on gender will be used. 120 patients with a confirmed diagnosis of COVID-19 by PCR and/or antigen testing will be randomized to the control group (placebo treatment) or experimental group (AM3 treatment), respectively. Patients will be randomly divided into two groups, the AM3 supplementation group (n=60) and the control group (n=60). The intervention group will be administered 2 indistinct capsules of AM3 (3 g/day of AM3) for 30 consecutive days, distributed in a single daily oral intake in the morning on an empty stomach. The control group will be administered a placebo of identical appearance of 2 indistinct capsules for a single daily intake in the morning, same dose as the experimental group (3 g/day of placebo), for 30 consecutive days.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years
- •Males and females
- •Confirmed clinical diagnosis of COVID-19 positive by Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) and/or SARS-CoV-2 Antigen Test performed 120 hours prior to patient inclusion in the study
- •LDH 250-400 U/L
- •Acceptance of informed consent signature
- •IMC: 18.5-30
- •Patients not participating in other trials
- •No hepatic and renal disorders
- •Possession of mental faculties to participate in the study
排除标准
- •Patients with rare and specific viral diseases such as HIV
- •Patients undergoing chemotherapy during the last 2 months
- •Any other condition/pathology diagnosed by the medical specialist that prevents them from participating in the trial
- •Intake of vitamin complexes or functional foods
结局指标
主要结局
Lactato deshidrogenasa (LDH)
时间窗: 30 days
a catalytic enzyme found in many tissues of the body
次要结局
- Aspartate Aminotransferase (AST)(1day and 30 days)
- Alanine Aminotransferase (ALT)(1day and 30 days)
- Interleukin 6 (IL-6)(1day and 30 days)
- Creatine kinase (CK)(1day and 30 days)
- Myoglobin (Mb)(1day and 30 days)
- Interleukin 1β (IL-1β)(1day and 30 days)
- tumor necrosis factor (TNF-α)(1day and 30 days)
- tumor necrosis factor receptor (TNFR-α)(1day and 30 days)
- C-reactive protein (CRP)(1day and 30 days)
- Ferritin (FER)(1day and 30 days)
研究者
Diego Fernandez Lazaro
Professor Doctor
University of Valladolid