A study to assess efficacy and safety of Ayurvedic formulation [CIM-MEG19] as an add-on therapy to the standard care in mild to moderate COVID 19 positive to combat the severity / recovery of symptoms / disorders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- A.To assess time to 2 point improvement (from time of enrolment) on the WHO ordinal scale
研究概览
简要总结
Study is an interventional, open label, double arm, randomized control trial to assess the safety and effectiveness of CIM-MEG19 compared to standard care medicines in adult patients of COVID-19. In this study eligible patients will be enrolled into 2 groups: Group A or interventional group will receive CIM-MEG19 along with standard care(and those who are notadvised Favipiravir and / or Remdesivirand / or any other antiviral drug for COVID management) and patients in Group B or control group will receive standard care alone (including antivirals). Considering lost-to-follow-ups, patients in each arm will be enrolled so as to achieve 28 complete follow-up patients.
The objectives of the study are as follows-
Primary objectives
-
To assess efficacy of CIM-MEG19 in Covid 19 patients in clinical improvement on WHO ordinal scale Secondary Objectives
-
To assess efficacy of CIM-MEG19 in reducing inflammatory markers
-
To assess proportion of RT-PCR negatives on Day 8 (+ 3 days)
-
To assess Improvement in oxygen saturation
-
To assess safety of CIM-MEG19 by AE/SAEs and LFT, RFT
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •COVID-19 RT-PCR positive patients Male or Female of age 18-70 years Subject is ready to give written Informed consent Can take oral medicines Mild to moderate grade of the disease.
- •Mild- Upper respiratory tract symptoms of fever with or without shortness of breath or hypoxia.
- •Moderate- Any one of-
- •Respiratory rate more than 24/min, breathlessness
- •SpO2: 90-93% on room air.
- •PaO2 /FiO2 : 200-300/g) as per AIIMS/ ICMR-COVID-19 National Task Force/Joint Monitoring Group recommendations Not participating in any other interventional drug study g) Agree to follow all study procedures.
排除标准
- •Known sensitivity to the ingredients of IP Bleeding haemorrhoids Pre-existing GI symptoms like nausea or vomiting Presence of acute hypoxic respiratory failure Intensive care unit (ICU) stay- Patients who need mechanical ventilation Category 6 or 5 based on modified 7-category ordinal scale of clinical status Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely Severe infection Pregnant or lactating women For Arm A: subjects receiving any antiviral treatment for Covid (like Favipiravir, Remdesivir).
结局指标
主要结局
A.To assess time to 2 point improvement (from time of enrolment) on the WHO ordinal scale
时间窗: Days- 0, 4, 8 and 21
次要结局
- Disease progression comparison in both arms(Frequency of serious adverse events in both the arms)