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Will treatment with a drug named colchicine be useful in treating Corona virus infection in kidney failure patients who are on regular dialysis?

Not Applicable
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
Inclusion Criteria

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.

Exclusion Criteria

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
NameTimeMethod
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
NameTimeMethod
To estimate all-cause mortality in each groupTimepoint: Day0 <br/ ><br>Day7 <br/ ><br>Day21 <br/ ><br>Day30
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