Clinical trial of CIM-Meg19 in COVID-19 patients
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/05/033543
- Lead Sponsor
- Ms Meghdoot Gramodyog Sewa Sansthan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
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- 1. Respiratory rate more than 24/min, breathlessness 2. SpO2: 90-93% on room air. 3. 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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A.To assess time to 2 point improvement (from time of enrolment) on the WHO ordinal scaleTimepoint: Days- 0, 4, 8 and 21
- Secondary Outcome Measures
Name Time Method Disease progression comparison in both arms <br/ ><br>Frequency of serious adverse events in both the arms <br/ ><br>Improvement in oxygen saturation <br/ ><br>Proportion of RT-PCR negatives on Day 8 day <br/ ><br>Number of hospital daysas compared to control group <br/ ><br>Changes in lab investigations on day 4 daysWRT day 0(like inflammatory markers, haemogram etc.) in blood investigations group <br/ ><br>Timepoint: 0, 8, 14 and 21 days