A randomized, Open Label, Standard controlled,2-Arm,prospective study to investigate the safety and efficacy of the SwasVimochan,SwasanRakshak,Swasamrit,Immune Energy Tablets in Mild to Moderate COVID-19 patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- 2)Improvement in Weakness.
研究概览
简要总结
The outbreak of coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2 in December 2019 has raised global health concerns. Coronaviruses (CoVs) are enveloped RNA Viruses related to the family Coronaviridae, the order Nirdovales, that infect humans and other mammals. The disease is characterized by fever, cough, headache and other constitutional symptoms. There has been morbidity and mortality with COVID-19.
A Proof of Concept study using SwasVimochan + SwasanRakshak + Swasamrit + Immune Energy Tablets as therapy in confirmed mild to moderate COVID-19 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject will be included in the study if they meet all of the following criteria:
- •Provides written informed consent.
- •Male or non-pregnant, non-lactating female aged > 18 and < 75 years (both inclusive)
- •RT-PCR confirmed diagnosis of COVID-
- •Finger Oxygen saturation 88 to 92% in rest state.
- •5.Able to take the drug orally and comply with study procedures.
- •Women of childbearing potential must have a negative urine pregnancy test prior to study entry.
排除标准
- •Patient with severe to critical type of health condition as stratified below: Clinical stratification: Severe type : meeting any of the following criteria: Respiratory distress, RR>30 times/min; Critical type:meeting any of the following criteria: a) Respiratory failure occurs and mechanical ventilator is required.
- •b) Patients go into shock.
- •c) ICU is needed for other organ failure.
- •Other viral pneumonia.
- •1.Patients on anticoagulant (such as aspirin, Wasfarin , heparine etc.) ( Note : patient who need anticoagulant added to their SOC regimen as per the discreation of the treating physician will be withdrawn from the study) 2.Patient who have recived tumor immunotherapy ( such as PD-1/L1,CTLA4, etc.) in the past 1 month, and inflammation factor modulator such as Ulinastatin.
- •3.patient who have received organ transplantation or surgery planning in the past 6 month.
结局指标
主要结局
2)Improvement in Weakness.
时间窗: 1) Proportion of patients showing clinical improvement Clinical improvement.Day 5, 9 and Upto Day 21. | 2)Improvement in Weakness.Up to 3 Weeks (21 Days). | 3)Improvement in SpO2 Levels. Up to 3 Weeks (21 Days). | 4)Time to first negative SARS-CoV-2 RT-PCR.Day 5, 9 and Upto 21 Days. | 5)Duration of hospitalization. Upto 3 Weeks. | 6) Duration of supplemental oxygen therapy, Upto 3 Weeks. | 7) Time to Normalization of Symptoms, Upto 3 Weeks.
6) Duration of supplemental oxygen therapy.
时间窗: 1) Proportion of patients showing clinical improvement Clinical improvement.Day 5, 9 and Upto Day 21. | 2)Improvement in Weakness.Up to 3 Weeks (21 Days). | 3)Improvement in SpO2 Levels. Up to 3 Weeks (21 Days). | 4)Time to first negative SARS-CoV-2 RT-PCR.Day 5, 9 and Upto 21 Days. | 5)Duration of hospitalization. Upto 3 Weeks. | 6) Duration of supplemental oxygen therapy, Upto 3 Weeks. | 7) Time to Normalization of Symptoms, Upto 3 Weeks.
4)Time to first negative SARS-CoV-2 RT-PCR.
时间窗: 1) Proportion of patients showing clinical improvement Clinical improvement.Day 5, 9 and Upto Day 21. | 2)Improvement in Weakness.Up to 3 Weeks (21 Days). | 3)Improvement in SpO2 Levels. Up to 3 Weeks (21 Days). | 4)Time to first negative SARS-CoV-2 RT-PCR.Day 5, 9 and Upto 21 Days. | 5)Duration of hospitalization. Upto 3 Weeks. | 6) Duration of supplemental oxygen therapy, Upto 3 Weeks. | 7) Time to Normalization of Symptoms, Upto 3 Weeks.
1) Proportion of patients showing clinical improvement.
时间窗: 1) Proportion of patients showing clinical improvement Clinical improvement.Day 5, 9 and Upto Day 21. | 2)Improvement in Weakness.Up to 3 Weeks (21 Days). | 3)Improvement in SpO2 Levels. Up to 3 Weeks (21 Days). | 4)Time to first negative SARS-CoV-2 RT-PCR.Day 5, 9 and Upto 21 Days. | 5)Duration of hospitalization. Upto 3 Weeks. | 6) Duration of supplemental oxygen therapy, Upto 3 Weeks. | 7) Time to Normalization of Symptoms, Upto 3 Weeks.
3)Improvement in SpO2 Levels.
时间窗: 1) Proportion of patients showing clinical improvement Clinical improvement.Day 5, 9 and Upto Day 21. | 2)Improvement in Weakness.Up to 3 Weeks (21 Days). | 3)Improvement in SpO2 Levels. Up to 3 Weeks (21 Days). | 4)Time to first negative SARS-CoV-2 RT-PCR.Day 5, 9 and Upto 21 Days. | 5)Duration of hospitalization. Upto 3 Weeks. | 6) Duration of supplemental oxygen therapy, Upto 3 Weeks. | 7) Time to Normalization of Symptoms, Upto 3 Weeks.
7) Time to Normalization of Symptoms.
时间窗: 1) Proportion of patients showing clinical improvement Clinical improvement.Day 5, 9 and Upto Day 21. | 2)Improvement in Weakness.Up to 3 Weeks (21 Days). | 3)Improvement in SpO2 Levels. Up to 3 Weeks (21 Days). | 4)Time to first negative SARS-CoV-2 RT-PCR.Day 5, 9 and Upto 21 Days. | 5)Duration of hospitalization. Upto 3 Weeks. | 6) Duration of supplemental oxygen therapy, Upto 3 Weeks. | 7) Time to Normalization of Symptoms, Upto 3 Weeks.
5)Duration of hospitalization.
时间窗: 1) Proportion of patients showing clinical improvement Clinical improvement.Day 5, 9 and Upto Day 21. | 2)Improvement in Weakness.Up to 3 Weeks (21 Days). | 3)Improvement in SpO2 Levels. Up to 3 Weeks (21 Days). | 4)Time to first negative SARS-CoV-2 RT-PCR.Day 5, 9 and Upto 21 Days. | 5)Duration of hospitalization. Upto 3 Weeks. | 6) Duration of supplemental oxygen therapy, Upto 3 Weeks. | 7) Time to Normalization of Symptoms, Upto 3 Weeks.
次要结局
- To evaluate the safety of SwasVimotion,SwasRaksha,Swasamrit,ImmuneEnergy tablet in comparison to the standard of care for the treatment of mild to mild to moderate COVID-19 disease.(1.Time(Days) to clinical improvement {Time Frame:upto 21 days}.)