Impact of Colchicine in Hospitalized Colombian Patients With COVID-19

Status Terminated

Clinical Trial Summary

This is a phase IIIa, prospective, open-label, randomized, parallel-group study designed to evaluate the efficacy and safety of oral colchicine plus standard therapy versus standard therapy in the clinical course of SARS-CoV-2 infection, in a population group with moderate COVID-19 compromise and requiring hospitalization.Aproximately 120 subjects meeting all inclusion and not inclusion criteria will be randomized to receive either Colchicine plus standard treatment or only standard treatment for 15 days

Clinical Trial Description

Introduction: COVID-19 and mortality associated with acute respiratory distress syndrome (ARDS) pose a global public health problem. The increase in spread and associated mortality poses a scenario where cost-effective therapeutic options are urgently and effectively proposed to control and reduce the pandemic and even to reduce the number of deaths Objective: To evaluate the efficacy and safety of oral colchicine plus treatment standard versus standard treatment in the clinical course of SARS-CoV-2 virus infection, in a population group with moderate COVID-19 involvement and requiring hospitalization. Methodology: A prospective, open, randomized, parallel-group study, the sample size of 120 subjects each arm of 60 subjects. Random assignment (1: 1) to either colchicine plus standard treatment or control arm (standard treatment) orally for 14 days. An initial dose of 1.5 mg orally on the first day, followed by 0.5 mg every 12 hours on days 2 to 7 and continuing with 0.5 mg a day until completing 14 days ± 1. It will be followed on days 1, 3, 7, 14, and day 28, evaluating physical examination, clinical situation, laboratories, and adverse events. The primary efficacy data correspond to the deterioration in the clinical status of the patients through the semiquantitative ordinal scale suggested by the WHO R&D committee. Expected results: It is expected to find out how, through different pathways, colchicine could act in modulating or preventing the appearance of ARDS associated with COVID-19, its possible effects on viral replication and antigenic presentation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04539873
Study type	Interventional
Source	Fundación Universitaria de Ciencias de la Salud
Contact
Status	Terminated
Phase	Phase 3
Start date	April 30, 2021
Completion date	October 30, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Impact of Colchicine in Hospitalized Colombian Patients With COVID-19 — (COLCOVID19)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms