Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-29 @ 3:00 PM
Study NCT ID:
NCT04416334
Status:
COMPLETED
Last Update Posted:
2023-11-08
First Post:
2020-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS
Sponsor:
Instituto de Investigación Marqués de Valdecilla
Organization:
Study Overview
Official Title:
PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS SARS-CoV2 (COVID-19)
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COLCHI-COVID
Brief Summary:
This is a phase 3 clinical trial, randomized, single-center, opened, controlled, to evaluate efficacy and safety of early administration of colchicines in patients older than 60 years, with high risk of pulmonary complications due to coronavirus SARS-CoV2 (COVID-19). An approximately number of 954 subjects meeting all inclusion and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment with paracetamol during 21 days.
Detailed Description:
The primary objective of the study is to determine whether short term course of colchicines reduces number of deaths due to COVID-19 and severe complications due to the virus in elderly patients with comorbidities.
The secondary objective is to determine the safety of colchicines in this patient population.
Approximately 954 subjects who meet all inclusion criteria and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment (2:1 allocation ratio) during 21 days. Follow-up assessments will occur every 48 hours and always at day 10, 21 and 61 following randomization for evaluation of the occurrence of any trial endpoints or other adverse events.
The secondary objective is to determine the safety of colchicines in this patient population.
Approximately 954 subjects who meet all inclusion criteria and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment (2:1 allocation ratio) during 21 days. Follow-up assessments will occur every 48 hours and always at day 10, 21 and 61 following randomization for evaluation of the occurrence of any trial endpoints or other adverse events.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: