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Impact of Colchicine in Hospitalized Colombian Patients With COVID-19

NCT04539873 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2022-02-23

No results posted yet for this study

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

Conditions

  • Corona Virus Infection

Interventions

DRUG

Colchicine 0.5 MG

Patientes in this arm will receive study medication colchicine 1,5 orally on the first day (initially two pills of 0,5 mg and 0.5 mg at 2 hours), followed by 0.5 mg every 12 hours on days 2 to 7, and continuing with 0.5 mg per day until completing 14 ± 1 days. The duration of treatment will be 14 ± 1 days, depending on the clinical judgment of the investigator.

COMBINATION_PRODUCT

CONTROL GROUP

In this case, the centers where the patients are enrolled will adhere to the Colombian guidelines (Colombian Consensus of the Colombian Association of Infectious Diseases)

Sponsors & Collaborators

  • Hospital de San Jose

    collaborator OTHER

  • Fundación Universitaria de Ciencias de la Salud

    lead OTHER

Principal Investigators

  • JHON JAIME SPROCKEL, MD; IM · Hospital de San Jose

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2021-10-30
Completion
2021-10-30

Countries

  • Colombia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04539873 on ClinicalTrials.gov