COVID-19 trials registries data warehouse

http://en.irct.ir/trial/46867

Masoud Mirzaei

mmirzaei@ssu.ac.ir

2020-05-18

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

- Age 18 to 70 years - Detection of COVID-19 in the last 24 to 48 hours - Candidate for hospitalization (o2sat <93% or RR> 24 or Pao2 / Fio2 <300) - COVID-19 patients hospitalized with hospital indications according to the guideline of the country that has pulmonary infiltration in CT scan -Not being pregnant and not becoming pregnant until 30 days after the end of the study - No consumption of colchicine during the last week ( due to the half-life of 20-40 hours of the drug) - Outpatients with pulmonary infiltration on CT scan

Patients with a history of Crohn or Ulcerative colitis, diarrhea, or chronic malabsorption Neuromuscular diseases GFR less than 30 ml per minute History of cirrhosis, hepatitis and severe liver disease Patients receiving chemotherapy for cancer Patients currently taking colchicine for other uses, such as gout or Mediterranean fever Patients with a history of allergic reactions or allergies to colchicine Pregnancy and lactation

2

Yazd University of Medical Sciences

18

70

Iran

Severe disease at enrollment

6: Severe disease at enrollment

200

-Clinical symptoms including fever, cough, shortness of breath pulmonary infiltration findings on CT scan o2sat at the time of hospitalization and discharge Laboratory symptoms (ESR, CRP, NLR, LDH, ferritin, D-dimer, CBC diff)

Phase 3

[{"arm_notes": "", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]