Impact of Colchicine in Hospitalized Colombian Patients With COVID-19

NCT04539873 | Terminated Phase 3 DMC

• 1 other identifier: 5175
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Colchicine; Gout; Antirheumatic Agents; Tubulin Modulators

Outcome Measures

Primary Outcomes (1)

• Number of participants who die or require transfer to Intesive care unit

  The primary endpoint will be the need of transfert to ICU or composite of dead due to COVID19 infection

  In the first 15 days after ramdomization

Secondary Outcomes (1)

• Number of participants who die

  15 days after ramdomization

Study Arms (2)

COLHICINE PLUS STANDARD TREATMENT

ACTIVE COMPARATOR

Patients treated in the exposed group will consist of a decreasing dose of colchicine: a dose of 1.5 mg orally on the first day (initial 1 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.

Drug: Colchicine 0.5 MG

STANDARD TREATMENT

PLACEBO COMPARATOR

In this case, the centers where the patients will be included adhere to the Colombian guidelines (Colombian Consensus of the Colombian Association of Infectious Diseases), and to standard treatment

Combination Product: CONTROL GROUP

Interventions

Colchicine 0.5 MG DRUG

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.

Also known as: EXPOSED GROUP

COLHICINE PLUS STANDARD TREATMENT

CONTROL GROUP COMBINATION_PRODUCT

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)

Also known as: standard treatment

STANDARD TREATMENT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fundación Universitaria de Ciencias de la Salud: lead
• Hospital de San Jose: collaborator

Study Sites (1)

Fundación Universitaria de Ciencias de La Salud

Bogota, Cundinamarca, 111411, Colombia

Location

Related Publications (4)

• Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

  PMID: 31986264 RESULT

• Wang M, Cao R, Zhang L, Yang X, Liu J, Xu M, Shi Z, Hu Z, Zhong W, Xiao G. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res. 2020 Mar;30(3):269-271. doi: 10.1038/s41422-020-0282-0. Epub 2020 Feb 4. No abstract available.

  PMID: 32020029 RESULT

• Savarino A, Di Trani L, Donatelli I, Cauda R, Cassone A. New insights into the antiviral effects of chloroquine. Lancet Infect Dis. 2006 Feb;6(2):67-9. doi: 10.1016/S1473-3099(06)70361-9. No abstract available.

  PMID: 16439323 RESULT

• Tay MZ, Poh CM, Renia L, MacAry PA, Ng LFP. The trinity of COVID-19: immunity, inflammation and intervention. Nat Rev Immunol. 2020 Jun;20(6):363-374. doi: 10.1038/s41577-020-0311-8. Epub 2020 Apr 28.

  PMID: 32346093 RESULT

MeSH Terms

Conditions

Coronavirus Infections; Gout

Interventions

Colchicine; Control Groups

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• JHON JAIME SPROCKEL, MD; IM

  Hospital de San Jose

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. Patients diagnosed with COVID-19 and meeting all eligibility criteria will be randomized for treatment in a 1: 1 ratio through a central voice response system. Randomization will be balanced in each of the 2 strata: 1) hospitalized patients with clinical stage 4 (requirement of supplemental oxygen by nasal contact lenses or mask) of the World Health Organization (WHO) classification, see ANNEX 2, who will receive in addition to the usual treatment for COVID-19 oral colchicine (exposed group); 2) hospitalized patients with clinical stage 4 of the WHO classification who will receive the usual treatment for COVID-19 (control group).

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 7, 2020
• Study Start: April 30, 2021
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)