NCT04416334

PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Instituto de Investigación Marqués de Valdecilla · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• SARS-CoV-2 Infection (COVID-19)

Interventions

Type	Name	Description
DRUG	Colchicine plus symptomatic treatment (paracetamol)	Colchicine plus symptomatic treatment (paracetamol).
DRUG	Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations)	Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations).

Timeline

• Start date: 2020-08-19
• Primary completion: 2022-06-01
• Completion: 2022-10-11
• First posted: 2020-06-04
• Last updated: 2023-11-08

Locations

4 sites across 1 country: Spain