DRC-06C

JRCT ID: jRCT2071200078

Registered date:07/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Corona VIrus Disease 2019
• Date of first enrollment: 13/01/2021
• Target sample size: 70
• Study type: Interventional
• Intervention(s): 1.5 mg of colchicine or placebo on day 1 and once daily oral administration of colchicine (0.5 mg) or placebo from day 2 to 28

Outcome(s)

• Primary Outcome: Area under the curve (AUC) of amount of change of serum C-reactive protein from baseline at 1, 2, 4 weeks after initiating investigational drug
• Secondary Outcome: Amount of change and area under the curve (AUC) of amount of change of neutrophil counts and lymphocyte counts (and its ratio), interleukin (IL)-1beta, IL-6, TNF-alpha, D-dimer, ferritin, von Willebrand factor, troponin, NT-proBNP, LDH from baseline at 1, 2, 4 weeks after initiating investigational drug

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients with a definitive diagnosis of COVID-19 and written informed consent.
(2) Patients with oxygen saturation of more than 94% at room air and having either or both of the following:
a. Pneumonia shadow on chest imaging
b. Having more than one risk factors of the followings:
Diabetes mellitus, Cardiovascular disease (coronary disease, stroke, peripheral arterial disease, heart failure), Chronic obstructive pulmonary disease, chronic kidney disease (30 <= eGFR < 60), Obesity (BMI >= 30), Elderly (age >= 65 )
(3) Patients hospitalized within 5 days after the onset of symptoms and with the ability of administrating the investigational drug by the second day of hospitalization
(4) Adult patients aged more than 20 at informed consent
(5) Patients or partners of patients agreed to prevent pregnancy for 90 days from the day of initiating investigational drug
(6) Patients being able to understand and willing to sign an IRB approved written informed consent document

Exclude criteria

(1)Asymptomatic patients
(2)Patients previously diagnosed COVID-19 in the past
(3)Known allergy or intolerance to colchicine
(4)Patients taking colchicine withing the past 30 days of consent date
(5)Patients taking biological drug withing the past 30 days of consent date
(6)Patients taking oral or intravenous corticosteroids withing the past 30 days of informed consent date
(7)Liver cirrhosis
(8)Clinical cholestasis
(9)Renal failure (eGFR < 30)
(10)Active or previous history of malignant disease
(11)Patients taking medicines as listed below:
a.Medicines strongly inhibiting CYP3A4
Atazanavir, Clarithromycin, Indinavir, Itraconazole, Nelfinavir, Ritonavir, Saquinavir, Darunavir, Telithromycin, Telaprevir, drugs containing kobishistat
b.Medicines moderately inhibiting CYP3A4
Amprenavir, Aprepitant, Diltiazem, Erythromycin, Fluconazole, Fosamprenavir, Verapamil
c.Medicines inhibiting P glycoprotein
Cyclosporine
(12)Patients taking Amiodarone or Quinidine
(13)Pregnant or possibly pregnant patients, patients with breastfeeding, patients willing to be pregnant
(14)Patients registered in other clinical trials/studies at informed consent date or in the past 30 days of informed consent date
(15)Patients being considered as inappropriate by attending physicians

Related Information

• Primary Sponsor: Kinjo Takeshi