COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45658

DrAlben Sigamani

krishna.kishore.dr@narayanahealth.org

2020-08-13

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Prevention

1.Patients between 18 to 65 years of age of either gender with end stage renal disease on regular dialysis <br/ >2.Willing to give informed consent

1.Pregnant and lactating women <br/ >2.Patients on CYP3A4 inhibitors and P- glycoprotein inhibitors <br/ >3.Patients with known blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia and aplastic anemia <br/ >4.Patients with Hepatitis B, ,Hep.C positive status and liver disorders <br/ >

2

Dr Krishna Kishore C

18

65

India

High risk patients

N/A

100

1.Feasibility outcomes will be time taken to recruit 100 patients and compliance for colchicine <br/ >2.Safety outcome includes treatment emergent adverse effects due to study drug and cessation of study drug due to adverse events <br/ >3. Efficacy outcome includes incidence of COVID infection between the 2 groups. <br/ >Timepoint: 6 Months <br/ >

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

Phase 2

[{"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"}]