A clinical trial to study the effects of two drugs methylprednisolone and dexamethasone in patients with severe COVID-19
Not Applicable
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/07/026608
- Lead Sponsor
- Dr Ananthakumar P K
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Age more than 18 years old
Both sex
Lab. Confirmed COVID-19 cases with ARDS
Exclusion Criteria
Mild and moderate COVID-19
Severe immunosuppression (HIV infection, long-term use of immunosuppressive agents
Pregnant or lactating women
Patients already on steroids
Patients with High Procalcitonin level
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcomes: <br/ ><br>Difference in IL-6 level from baseline. <br/ ><br>Days to ventilator liberation <br/ ><br>Length of hospital stay (LOS). <br/ ><br>In-hospital all-cause mortality. <br/ ><br>The secondary outcomes <br/ ><br>Time to fever resolution <br/ ><br>Levels of bio-markers (CRP, D dimer, Ferritin) on Day 1 and Day 3. <br/ ><br>Timepoint: Day 1 and Day 3 for IL-6 level <br/ ><br>
- Secondary Outcome Measures
Name Time Method patient details like baseline demographic data, laboratory reports â?? lymphocyte count, CRP, procalcitonin, Ferritin, D-dimer and clinical parameters including length of hospital stay and days in ventilator will be recorded before and after treatment with dexamethasone/methylprednisolone. <br/ ><br>Timepoint: from day 1 to day 3 for variation in CRP <br/ ><br>ferritin