COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55323

Utkarash Mishra

santosh.vellore@gmail.com

2021-05-11

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

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 <br/ >2.Not willing to enter the study <br/ >3.Known hypersensitivity to colchicine. <br/ >4.Inflammatory bowel disease, chronic diarrhea or malabsorption <br/ >5.Previous neuromuscular disease <br/ >6.Cirrhosis, active chronic hepatitis or severe hepatic disease defined by SGOT or SGPT levels three times above the normal upper limit <br/ >7.Treatment with immunosuppressive agents, corticosteroids or interleukine-1 antagonists for 6 months before inclusion <br/ >8.Pregnant or breastfeeding females <br/ >9.Patient currently taking colchicine for indications other than SARS-CoV-2 infection prophylaxis <br/ >10.History of prolongation of the QT interval (eg. History of torsades de pointes, congenital long QT syndrome, bradyarrhthmia) <br/ >11.Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study <br/ >

2

CMC Fluid research Funding

18

85

India

No restriction on type of patients

0: No restriction on type of patients

80

Time to deterioration by 2 points on the WHO clinical progression scale; ranging from asymptomatic viral RNA detection to deathTimepoint: Day0 <br/ >Day7 <br/ >Day21 <br/ >Day30

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]