Prospective , multi center ,single blind , randomized controlled study on evaluation of use of , “AyurCoro3†as an adjuvant for the treatment purpose in mild to moderate COVID-19 patients at tertiary care center.
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Time (Days) to clinical improvement from study enrolment
研究概览
简要总结
Prospective ,single center ,single blinded, randomized controlled study on evaluation of use of , “AyurCoro3â€as an adjuvant for the treatment purposein mild to moderate COVID-19 patients at tertiary care center.Studyprocedures shall be initiated post obtaining written informed consent process,as per local regulatory requirements. Randomization of the groups would be doneas per computer generated charts , details of the randomization are as perbelow mentioned chart. Randomizationchart is enclosed along with the protocol for reference .
Theparticipants were randomly allotted in the ratio 1:1 using a computer-generatedrandom-number list to either the ’Control Arm’ (‘Standard of Care’) orthe ’Intervention Arm’ (Study Medicineas an adjuvant to ’Standard of Care’). A total of 500 Patients would berandomized,250 in Control and 250 in Interventions. The participants wontnot incur any personal cost owing to the study .
Therandomization sequence with a size of 4 was generated by a statistician who wasnot part of the study team. Eligible patients are allocated to receivemedication, according to the sequential order. Envelopes are prepared foremergency unmasking. Laboratory technicians are blinded to treatmentallocation. The evaluators and statisticians are blinded until the completionof the visit and analysis. Data validation, cleaning and statistical analysisare done by trial researchers in collaboration with the Indian Institute ofTechnology Bombay (IIT Bombay), India. A Dedicated Research Coordinator who hadno involvement in the participant enrollment, would be doing the random allocation. ". After ensuring eligibilityof patients, a Dedicated Research Coordinator would communicate the assigned treatment to the recruiting investigator.
Study doctor will follow up telephonically 1 week postdischarge to enquire study participants about their health status for functional status scale -post covid-19 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Laboratory confirmed diagnosis of Mild to Moderate COVID-19 patients
- •Agree to consent for the study.
- •All Age groups above 18 Years
- •All genders.
排除标准
- •1.Patients on ventilator 2.Critically ill patient 3.Dyspnea, respiratory frequency ≥ 30/min, 4.Blood oxygen saturation (SpO2) ≤ 90%, 5.PaO2/FiO2 ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours 6.Patients with altered mental state 7.Patients with multiple organ failure requiring ICU monitoring and treatment.
- •8.Patients with respiratory failure and requiring mechanical ventilation/ 9.Patient who have participated in another investigational study within 3 months prior to enrollment in this study 10.Investigators, study personnel and their first-degree relatives.
- •11.Pregnant Patients 12.Current or future involvement in the active treatment phase of other interventional research studies (excluding observational/non-interventional studies).
- •13.Any other clinical reason which may preclude entry in the opinion of the investigator.
结局指标
主要结局
Time (Days) to clinical improvement from study enrolment
时间窗: At Baseline, Day three , Day five and Day seven
次要结局
- 1.Clinical status as assessed by the 9-point ordinal scale(2.Duration of hospitalization)