COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04818489

Emad Issak

Mariam Maged, mariamaged@yahoo.com (PI email not reported)

2021-03-26

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - patients who are confirmed to have covid-19 clinically, radiologically and pcr - age above 18 years old - informed written consent

- history of hypersensitivity to colchicine - pregnancy or breastfeeding women. - patients with severe renal impairment (creatinine clearance (ccl) <30 ml / min) - patients with severe hepatic impairment (ast or alt> 5 times the normal limits in international units (uln) - patients with blood dyscrasias, neutrophils <1.000 / mmc or platelets <50.000 / mmc - patients with history of severe cardiac insufficiency - patients with history of pulmonary fibrosis - severe diarrhoea or bowel diverticulitis, or perforation - patients who cannot take oral therapy - patients already in icu or requiring mechanical ventilation - patients already enrolled in other clinical trials - patients with taking p-glycoprotein inhibitor (e.g. ciclosporin, verapamil or quinidine) or a cyp3a4 inhibitor (e.g. ritonavir, remdesivir, atazanavir, indinavir, clarithromycin, telithromycin, itraconazole or ketaconazole) or tocilizumab

2

ClinAmygate

18

100

Egypt

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

260

Clinical status;Pulmonary fibrosis at 45 days;Pulmonary fibrosis at week 2

None

Phase 4

[{"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"}]