Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
Exclusion criteria: 1.Age 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to deterioration by 2 points on the WHO clinical progression scale, ranging from asymptomatic viral RNA detection to deathTimepoint: Day0 Day7 Day21 Day30 | — |
Secondary
| Measure | Time frame |
|---|---|
| To estimate all-cause mortality in each groupTimepoint: Day0 Day7 Day21 Day30 | — |
Countries
India
Contacts
Christian Medical College, Vellore