Will treatment with a drug named colchicine be useful in treating Corona virus infection in kidney failure patients who are on regular dialysis?
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/05/033537
- Lead Sponsor
- CMC Fluid research Funding
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patients with end stage kidney disease who are on maintenance hemodialysis in our institute, who develop SARS-CoV-2 infection and who do not meet exclusion criteria, after written informed consent.
1.Age < 18 years
2.Not willing to enter the study
3.Known hypersensitivity to colchicine.
4.Inflammatory bowel disease, chronic diarrhea or malabsorption
5.Previous neuromuscular disease
6.Cirrhosis, active chronic hepatitis or severe hepatic disease defined by SGOT or SGPT levels three times above the normal upper limit
7.Treatment with immunosuppressive agents, corticosteroids or interleukine-1 antagonists for 6 months before inclusion
8.Pregnant or breastfeeding females
9.Patient currently taking colchicine for indications other than SARS-CoV-2 infection prophylaxis
10.History of prolongation of the QT interval (eg. History of torsades de pointes, congenital long QT syndrome, bradyarrhthmia)
11.Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to deterioration by 2 points on the WHO clinical progression scale, ranging from asymptomatic viral RNA detection to deathTimepoint: Day0 <br/ ><br>Day7 <br/ ><br>Day21 <br/ ><br>Day30
- Secondary Outcome Measures
Name Time Method To estimate all-cause mortality in each groupTimepoint: Day0 <br/ ><br>Day7 <br/ ><br>Day21 <br/ ><br>Day30