Colchicine for preventing respiratory failure in COVID-19 with fever

Phase 2

Recruiting

• Conditions: COVID-19; D000086382

• Registration Number: JPRN-jRCTs031210579
• Lead Sponsor: Yokogawa Naoto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion 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.

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
se of oxygen (for 12 hours or longer) during admission or by Day 28

Secondary Outcome Measures

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