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

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ClinicalTrials.gov Identifier: NCT04539873
Recruitment Status : Not yet recruiting
First Posted : September 7, 2020
Last Update Posted : February 24, 2021
Sponsor:
Collaborator:
Hospital de San Jose
Information provided by (Responsible Party):
Fundación Universitaria de Ciencias de la Salud

Study Description
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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

Condition or disease Intervention/treatment Phase
Corona Virus Infection Drug: Colchicine 0.5 MG Combination Product: CONTROL GROUP Phase 3

Detailed 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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).
Masking: Single (Participant)
Masking Description: 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
Primary Purpose: Treatment
Official Title: Impact of Colchicine in Hospitalized Colombian Patients With COVID-19
Estimated Study Start Date : March 15, 2021
Estimated Primary Completion Date : July 15, 2021
Estimated Study Completion Date : September 15, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: COLHICINE PLUS STANDARD TREATMENT
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
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.
Other Name: EXPOSED GROUP
Placebo Comparator: STANDARD TREATMENT
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
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)
Other Name: standard treatment


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants who die or require transfer to Intesive care unit [ Time Frame: In the first 15 days after ramdomization ]
    The primary endpoint will be the need of transfert to ICU or composite of dead due to COVID19 infection


Secondary Outcome Measures :
  1. Number of participants who die [ Time Frame: 15 days after ramdomization ]
    The secondary end point is the ocurrence of death in the 15 days after ramdomization


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04539873


Contacts
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Contact: GIOVANNI MONTEALEGRE, MD. PS +571 3538100 giosurg@hotmail.com
Contact: WALTER CHAVES, MD; IM +571 3538100 wchaves@fucsalud.edu.co

Locations
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Colombia
Fundación Universitaria de Ciencias de La Salud
Bogota, Cundinamarca, Colombia, 111411
Contact: ARLEY GOMEZ, MD;PhD    +5714375401 ext 5150    agomez@fucsalud.edu.co   
Contact: HECTOR RESTREPO    +5714375401 ext 5150    hfrestrepo@fucsalud.edu.co   
Principal Investigator: WALTER CHAVES, MD. IM         
Sub-Investigator: JHON JAIME SPROCKEL, MD.IM         
Sponsors and Collaborators
Fundación Universitaria de Ciencias de la Salud
Hospital de San Jose
Investigators
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Study Chair: JHON JAIME SPROCKEL, MD; IM Hospital de San Jose
More Information
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Publications of Results:

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Responsible Party: Fundación Universitaria de Ciencias de la Salud
ClinicalTrials.gov Identifier: NCT04539873    
Other Study ID Numbers: 5175
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación Universitaria de Ciencias de la Salud:
Colchicine
Gout
Antirheumatic Agents
Tubulin Modulators
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
 Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents