Impact of Colchicine in Hospitalized Colombian Patients With COVID-19

• Status: Not yet recruiting
• Trial end date: 2021-12-15
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Universitaria de Ciencias de la Salud
• Collaborator: Hospital de San Jose
• Treatments: Colchicine

Criteria

Inclusion Criteria:

• Patients ≥18 years old.

• Laboratory-confirmed SARS-CoV-2 infection: infection confirmed with nasopharyngeal swab by positive RT PCR in the last 48 hours.

• Hospital admission for COVID-19 in the previous 48 hours.

• Clinical stage 3 (no supplemental oxygen requirement) or 4 (supplemental oxygen requirement for nasal contact lenses or mask) of the WHO classification (see ANNEX 2).

• The patient must be able and willing to provide informed written consent before performing study procedures.

• Patient confirmed to covid19 as positive by positive PCR test

Exclusion Criteria:

• Pregnancy, nursing mothers, and women of childbearing potential who are unable to use adequate contraception.

• Known hypersensitivity or other clear contraindication to the use of colchicine.

• History of end-stage renal disease (eGFR <30 ml / min / 1.73 m2).

• Medical history of cirrhosis (Child-Pugh C), liver failure, chronic active hepatitis, or severe liver disease defined by alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 5 times the upper limit of normal.

• History of pre-existing neuromuscular disease.

• Previous severe hematologic disease or bleeding disorders.

• Inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea, or malabsorptive syndrome.

• Colchicine treatment for other indications.

• Treatment with immunosuppressive/immunomodulatory agents, including glucocorticoids, antivirals, antimalarials, and IL 6 antagonists for 30 days prior to enrollment.

• Use of other investigational drugs at the time of inclusion, or during the 30 days prior to inclusion.

• Any medical condition or disease that, in the opinion of the investigator, may place the patient at unacceptable risk to participate in the study.