Effect of IMMUNEPOTENT-CRP, a Bovine Dialyzable Leukocyte Extract, on Serum Pro-Inflammatory Cytokines in Outpatients with Mild to Moderate COVID-19: a Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Cytokine and Chemokine Serum Levels Evaluation
研究概览
简要总结
In this study, the effects of IMMUNEPOTENT-CRP (I-CRP), a dialyzable leukocyte extract (DLE) derived from bovine spleen cells, on the levels of key inflammatory cytokines in outpatients with COVID-19 were examined. I-CRP has been previously studied for its ability to regulate the immune system in other conditions, such as cancer and sepsis. Based on its potential to reduce harmful inflammation, the study aimed to determine if similar benefits could be observed in COVID-19 outpatients.
详细描述
Outpatients with mild to moderate COVID-19 symptoms and a confirmed SARS-CoV-2 infection were enrolled. These patients were randomly assigned to receive either IMMUNEPOTENT-CRP (I-CRP) or a placebo over a 14-day period. The study was double-blind, meaning neither the patients nor the researchers knew who was receiving I-CRP or placebo, ensuring unbiased results. The main objective of the study was to measure changes in the levels of specific cytokines and chemokines in the blood-IL-1β, IL-6, IL-10, TNF-α, IFN-α, IFN-γ, and IL-8-which are key players in the inflammatory response linked to severe COVID-19 cases. High levels of these molecules are associated with worse outcomes and more severe symptoms. Additionally, other markers of inflammation and immune system activity, such as lactate dehydrogenase (LDH), high-sensitivity C-reactive protein (hs-CRP), ferritin, and D-dimer, were measured, as these are commonly used to assess the severity of inflammation and risk of complications in COVID-19 patients.
Throughout the study, outpatients were regularly monitored for symptoms, and their vital signs-such as oxygen levels and body temperature-were checked during home visits. Blood samples were collected at different intervals to measure cytokine levels and the other included inflammatory markers. Patients were also tested four times for the presence of the virus to determine their infection status during the follow-up period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Laboratory-confirmed SARS-CoV-2 infection (by antigen or RT-qPCR test).
- •With mild to moderate symptoms of COVID-
- •Aged ≥ 18 years.
- •Not participating in any other clinical study.
- •Written informed consent duly signed.
- •Outpatients
排除标准
- •Undergoing any process of primary or secondary immunosuppression.
- •Any autoimmune disease.
- •Receiving chemotherapy.
- •History of lymphoma or any malignancy.
- •Pregnancy or breastfeeding women.
研究组 & 干预措施
I-CRP group
IMMUNEPOTENT-CRP (I-CRP) was supplied in a 5 Unit (U) per vial presentation. One U is defined as the lyophilized product obtained from the dialysis of 1×10^8 bovine spleen cells. The dosing schedule extended over 14 days. On the first day (Day 0), outpatients ingested seven doses at two-hour intervals each one. From days one through four, four doses were taken one every four hours, and from days five to thirteen, three doses were consumed one every eight hours.
干预措施: IMMUNEPOTENT-CRP (I-CRP) (Biological)
Placebo control
The placebo was prepared from a lyophilized corn starch extract and was provided in an identical appearance and presentation to IMMUNEPOTENT-CRP (I-CRP). The dosing schedule extended over 14 days. On the first day (Day 0), outpatients ingested seven doses at two-hour intervals each one. From days one through four, four doses were taken one every four hours, and from days five to thirteen, three doses were consumed one every eight hours.
干预措施: Placebo Comparator (Biological)
结局指标
主要结局
Cytokine and Chemokine Serum Levels Evaluation
时间窗: Assessments were performed at baseline (Day 0), and during the intervention period at Day 7 and Day 14.
Serum levels of IL-1β, IL-6, IL-10, TNF-α, IFN-α, IFN-γ, and IL-8 were measured using the Human Cytokine/Chemokine Magnetic Bead Panel (Milliplex, Darmstadt, Germany). Cytokine and chemokine concentrations in the serum are expressed in pg/mL.
次要结局
- Lactate Dehydrogenase (LDH) Levels(Measurements were taken at baseline (Day 0), Day 7, and Day 14 during the intervention period.)
- High-Sensitivity C-Reactive Protein (hs-CRP) Levels(Measurements were taken at baseline (Day 0), Day 7, and Day 14 during the intervention period.)
- Ferritin Levels(Measurements were taken at baseline (Day 0), Day 7, and Day 14 during the intervention period.)
- D-Dimer Levels(Measurements were taken at baseline (Day 0), Day 7, and Day 14 during the intervention period.)
- Lymphocyte Subpopulations(Lymphocyte subpopulation counts in whole blood were measured at baseline (Day 0), Day 7, and Day 14 during the administration of I-CRP or placebo.)
- SARS-CoV-2 Infection Status Evaluation(SARS-CoV-2 infection status was evaluated at baseline (Day 0), Day 7, Day 14, and Day 30 during outpatient follow-up.)
研究者
Dr. Jose Manuel Vazquez-Guillen
Full-Time Research Professor
Universidad Autonoma de Nuevo Leon