CTRI/2020/09/027685已完成未知
A Randomized, Open Label,2 Arm, Prospective Study to Investigate the Safety and Efficacy of the Health Supplements ImmunoSEB+ ProbioSEB CSC3 as Supplemental therapy in Confirmed Mild to Moderate COVID-19 Patients.
Chirayu Medical College and Hospital0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Patient who provides written informed consent
- •2.Male or non-pregnant, non-lactating female aged 18 to 75 years (both inclusive)
- •3.RT-PCR confirmed diagnosis of COVID-19
- •4.Able to take the drug orally and comply with study procedures
- •5.Women of childbearing potential must have a negative urine pregnancy test prior to study entry
排除标准
- •1. Severe Type
- •Respiratory distress, RR >30 times/min
- •Finger oxygen saturation <93% in rest state
- •Arterial partial pressure of oxygen (PaO2)/concentration of oxygen inhalation FiO2 >300mmHg
- •2. Critical type: meeting any of the following criteria
- •Respiratory failure occurs and mechanical ventilation is required
- •Patients go into shock
- •ICU is needed for other organ failure.
- •3.Patients who have received tumor immunotherapy such as
- •PD-1/L1 CTLA4 etc. in the past 1 month, and inflammatory factor modulators such as Ulinastatin.
- •4.other viral pneumonia
- •5.patients who have received tumor immunotherapy in the past one
- •month and inflammatory factor modulators such as Ulinastatin
- •6. patients who have received organ transplantation or surgery
- •planning in the past 6 months
- •7. patients who cant take food or drugs due to coma or intestinal obstruction
- •8.Patients who have severe underlying diseases that affects survival,including uncontrolled malignant tumor with multiple metastases that
- •cannot be resected, blood diseases, dyscrasia, active bleeding,severe malnutrition, etc
- •9.Women subjects that are pregnant or lactating, or subjects (including male subjects) having a pregnancy plan (including plans for sperm donation or egg donation) during the study period
- •10.Allergic to systemic enzyme supplements
- •11.Patients whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper
- •limit of normal, or patients with child-Pugh grade C cirrhosis
- •12.ECLS (ECMO, ECCO2R, RRT)
- •13.Imminent death in the opinion of the clinical team
- •14.Patients who have participated in any other clinical study within 2 weeks prior to randomization
- •15.The investigator concludes that the patient is not suitable for the study
研究者
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