Evaluation of the Effectiveness of Therapy for Patients With Covid-19 Using Food Supplements Viusid + Asbrip
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Mean duration of hospitalization.
研究概览
简要总结
This is a two-arm, randomized, open label, monocenter, controlled study to evaluate the safety and efficacy of Viusid plus Asbrip in patients with mild and moderate symptoms of respiratory illness caused by Coronavirus 2019 infection.
详细描述
This is a two-arm, randomized, open label, monocenter, controlled study to evaluate the safety and efficacy of Viusid plus Asbrip in patients with mild and moderate symptoms of respiratory illness caused by Coronavirus 2019 infection.
A total of 80 subjects will be randomized 2:1 in this study. 50 patients will be assigned to receive daily oral doses of 4,5 g of Viusid every 12 hours and 10 ml of Asbrip every 12 hours and standard care with antivirals or not. Other 30 patients will be assigned to receive only standard care.
Treatment duration: 21 days
Objective of the study: to increase the effectiveness of therapy for patients with Covid-19 using food supplements Viusid and Asbrip.
Research objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 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
Viusid Plus Asbrip Adjuvant
25 Patients who received standard therapy Remdesivir IV 200 mg for the first day and then 100 mg daily for the next 4 days AND Viusid (sachets with powder for dilution, oral administration) 1 sachet bid and Asbrip (liquid form, oral administration) 10 ml bid for the total duration of hospitalization. Time Frame: 21 days.
干预措施: Viusid and Asbrip (Dietary Supplement)
Viusid Plus Asbrip Adjuvant
25 Patients who received standard therapy Remdesivir IV 200 mg for the first day and then 100 mg daily for the next 4 days AND Viusid (sachets with powder for dilution, oral administration) 1 sachet bid and Asbrip (liquid form, oral administration) 10 ml bid for the total duration of hospitalization. Time Frame: 21 days.
干预措施: COVID-19 Standard Therapy (Drug)
Viusid Plus Asbrip Monotherapy
25 Patients who did not receive standard antiviral therapy with the inclusion of food supplements Viusid (4.5 gr every 12 hours, oral administration) and Asbrip (10 mL every 12 hours, oral administration). Time Frame: 21 days.
干预措施: Viusid and Asbrip (Dietary Supplement)
Control
30 patients who received standard therapy (Remdesivir IV 200 mg for the first day and then 100 mg daily for the next 4 days), without the inclusion of food supplements Viusid and Asbrip.
干预措施: COVID-19 Standard Therapy (Drug)
结局指标
主要结局
Mean duration of hospitalization.
时间窗: 21 days
Media of time in days to discharge in each group. Discharge is considered once the patient complete the following conditions: * Normal body temperature for 2 days (36.1 - 37.2 degrees Celsius will be considered as normal body temperature). * Normal appetite for 4 days. * Normal Complete Blood Count (CBC): Following values will be considered as normal values in CBC: Red blood cell count: Male: 4.35-5.65 million cells/mcL; Female: 3.92-5.13 million cells/mcL. Hemoglobin: Male: 13.2-16.6 grams/dL; Female: 11.6-15 grams/dL. Hematocrit: Male: 38.3-48.6 percent; Female: 35.5-44.9 percent. White blood cell count: 3,400 to 9,600 cells/mcL. Platelet count: Male: 135-317 billion/L; Female: 157-371 billion/L. * No requirement in oxygen support. * Decrease in or normal CRP: 0.8-1.0 mg/dL (or 8-10 mg/L) or lower will be considered as normal values. * Any decrease in IL-6 level lower than doubled normal value: between 0 and 43.5 pg/ml will be considered as normal values.
次要结局
- Mean levels of IL-6 concentration(21 days)
- Mean levels of Ferritin concentration(21 days)
- Peripheral blood c-reactive protein concentration(21 days)
- Mean levels of D-Dimer concentration(21 days)