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Will colchicine be useful as an agent to prevent SARS-CoV-2 infection in kidney failure patients who are on maintenance hemodialysis?

Colchicine for prophylaxis against 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/2021/05/033605
Enrollment
200
Registered
2021-05-13
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 prophylaxis and the standard of care preventive measures for SARS-CoV-2 infection: In the intervention arm, all patients will be receiving tablet colchicine 0.5mg per-orally

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, not meeting 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 interleukin-1 antagonists for 6 months before inclusion 8.Pregnant or breastfeeding females 9.Patient currently taking colchicine for other indications 10.Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study

Design outcomes

Primary

MeasureTime frame
To estimate the incidence of SARS-CoV-2 infection during a follow up period of 24 months in both the groupsTimepoint: To estimate the incidence of SARS-CoV-2 infection during a follow up period of 24 months in both the groups—

Secondary

MeasureTime frame
1. To estimate the difference in time to symptomatic infection in both the groups 2. To estimate the incidence of colchicine related adverse events in the intervention group 3. To estimate the difference in presentation severity of SARS-CoV-2 infection in both the groups. 4. To estimate the difference in clinical course of SARS-CoV-2 infection in both the groups. 5. To estimate the difference in duration of hospitalization in both the groups.Timepoint: 24months—

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