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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?

Colchicine for treating SARS-CoV-2 infection in maintenance hemodialysis patients: a prospective, open label, randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033537
Enrollment
80
Registered
2021-05-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Colchicine and Standard of care for the treatment of SARS-CoV-2 infection: All patients will be receiving loading dose of 1mg and thereafter once daily oral colchicine 0.5mg for a peri

Sponsors

CMC Fluid research Funding
Lead Sponsor

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

MeasureTime 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

MeasureTime frame
To estimate all-cause mortality in each groupTimepoint: Day0 Day7 Day21 Day30

Countries

India

Contacts

Public ContactUtkarash Mishra

Christian Medical College, Vellore

santosh.vellore@gmail.com9442380267

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026