A clinical trial to study the effects of two drugs methylprednisolone and dexamethasone in patients with severe COVID-19

Not yet recruiting

• Conditions: Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2020/07/026608
• Lead Sponsor: Dr Ananthakumar P K

Brief Summary

This study is a randomised,parallel group,single-centre trial comparing the effect of methylprednisolone 1mg/kg intravenous once a day for 3 days and intravenous dexamethasone 6 mg once a day for 3 days in 40 patients in India. The primary outcome measures are difference in IL-6 level from baseline,days to ventilator liberation, length of hospital stay, in hospital  all cause mortality and the secondary outcomes are time to fever resolution, levels of biomarkers(CRP,D dimer,Ferritin) on day 1 and day 3.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-07-15
• Study Start: 2020-07-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

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
Length of hospital stay (LOS).	Day 1 and Day 3 for IL-6 level
Primary outcomes:	Day 1 and Day 3 for IL-6 level
The secondary outcomes	Day 1 and Day 3 for IL-6 level
Difference in IL-6 level from baseline.	Day 1 and Day 3 for IL-6 level
Days to ventilator liberation	Day 1 and Day 3 for IL-6 level
In-hospital all-cause mortality.	Day 1 and Day 3 for IL-6 level
Time to fever resolution	Day 1 and Day 3 for IL-6 level
Levels of bio-markers (CRP, D dimer, Ferritin) on Day 1 and Day 3.	Day 1 and Day 3 for IL-6 level

Secondary Outcome Measures

Name	Time	Method
patient details like baseline demographic data, laboratory reports – 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.

Trial Locations

Locations (1)

Chettinad Hospital and Research Institute; 🇮🇳 Kancheepuram, TAMIL NADU, India

Chettinad Hospital and Research Institute

🇮🇳Kancheepuram, TAMIL NADU, India

Dr Ananthakumar P K

Principal investigator

9620916481

drananthakumarpk@gmail.com