Colchicine for preventing respiratory failure in COVID-19 with fever

JRCT ID: jRCTs031210579

Registered date:24/01/2022

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 24/01/2022
• Target sample size: 240
• Study type: Interventional

Intervention(s)

Colchicine 0.5 mg tablets for 6 days or until the date of discharge. When oxygen is started, colchicine is discontinued.
Age <70 years old and eGFR >= 60
Day 1-2: 3 tablets a day
Day 3-6: 2 tablets a day
Age >=70 years old or eGFR of <60
Day 1-2: 2 tablets a day
Day 3-6: 1 tablets a day

Outcome(s)

• Primary Outcome: Use of oxygen (for 12 hours or longer) during admission or by Day 28

Secondary Outcome

Oxygen-free survival at Day 7
One category improvement from baseline using 7-point ordinal scale on Day 7
Two category improvement from baseline using 7-point ordinal scale on Day 7
Duration of fever
Duration of admission
Death at discharge or Day 28

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 84age old
• Gender: Both

Include criteria

1) Positive SARS-CoV-2 test (confirmed by antigen test or nucleic acid detection test using samples collected within 2 weeks before eligibility evaluation)
2) After 4 days from the onset ( If the onset date is unknown, the SARS-CoV-2 test date will be used. )
3) High fever (38.0 degrees or higher) within 24 hours before inclusion (body temperature may be confirmed by the patient's fever record or accommodation facility record).
4) The age at the time of obtaining consent is 18 to 84 years old
5) Those who understand the contents of the clinical trial and can obtain written consent to participate in the trial.

Exclude criteria

1) Those who require oxygen (room oxygen saturation of 93% or less )
2) Those who do not agree to treatment in hospital
3) Those who are taking colchicine
4) Those who are taking 10 mg or more of prednisolone daily (or equivalent dose of other glucocorticoids)
5) Use of glucocorticoids (orally or intravenously) within the past week.
6) Sleep apnea syndrome or suspected sleep apnea syndrome
7) Severe diarrhea
8) Use of CYP3A4 inhibitor or P-glycoprotein inhibitor
9) Liver dysfunction AST or ALT exceeds 5 times the upper limit of normal value
10) Renal dysfunction eGFR less than 30mL / min / 1.73m2
11) Patients with a history of hypersensitivity to the ingredients of this drug
12) Pregnant women or women who may be pregnant at the interview

Related Information

• Primary Sponsor: Yokogawa Naoto