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

Primary Purpose

Corona Virus Infection

Status

Terminated

Phase

Phase 3

Locations

Colombia

Study Type

Interventional

Intervention

Colchicine 0.5 MG

CONTROL GROUP

About this trial

This is an interventional treatment trial for Corona Virus Infection focused on measuring Colchicine, Gout, Antirheumatic Agents, Tubulin Modulators

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fundación Universitaria de Ciencias de La Salud

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

COLHICINE PLUS STANDARD TREATMENT

STANDARD TREATMENT

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of participants who die

The secondary end point is the ocurrence of death in the 15 days after ramdomization

Full Information

NCT ID

NCT04539873

First Posted

August 29, 2020

Last Updated

February 7, 2022

Sponsor

Fundación Universitaria de Ciencias de la Salud

Collaborators

Hospital de San Jose

1. Study Identification

Unique Protocol Identification Number

NCT04539873

Brief Title

Impact of Colchicine in Hospitalized Colombian Patients With COVID-19

Acronym

(COLCOVID19)

Official Title

Impact of Colchicine in Hospitalized Colombian Patients With COVID-19

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Terminated

Why Stopped

non-inclusion of patients in the study effectively

Study Start Date

April 30, 2021 (Actual)

Primary Completion Date

October 30, 2021 (Actual)

Study Completion Date

October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fundación Universitaria de Ciencias de la Salud

Collaborators

Hospital de San Jose

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Corona Virus Infection

Keywords

Colchicine, Gout, Antirheumatic Agents, Tubulin Modulators

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

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

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

Allocation

Randomized

Enrollment

128 (Actual)

8. Arms, Groups, and Interventions

Arm Title

COLHICINE PLUS STANDARD TREATMENT

Arm Type

Active Comparator

Arm Description

Arm Title

STANDARD TREATMENT

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Colchicine 0.5 MG

Other Intervention Name(s)

EXPOSED GROUP

Intervention Description

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.

Intervention Type

Combination Product

Intervention Name(s)

CONTROL GROUP

Other Intervention Name(s)

standard treatment

Intervention Description

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)

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

In the first 15 days after ramdomization

Secondary Outcome Measure Information:

Title

Number of participants who die

Description

The secondary end point is the ocurrence of death in the 15 days after ramdomization

Time Frame

15 days after ramdomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JHON JAIME SPROCKEL, MD; IM

Organizational Affiliation

Hospital de San Jose

Official's Role

Study Chair

Facility Information:

Facility Name

Fundación Universitaria de Ciencias de La Salud

City

Bogota

State/Province

Cundinamarca

ZIP/Postal Code

111411

Country

Colombia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31986264

Citation

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. Erratum In: Lancet. 2020 Jan 30;:

Results Reference

result

PubMed Identifier

32020029

Citation

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.

Results Reference

result

PubMed Identifier

16439323

Citation

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.

Results Reference

result

PubMed Identifier

32346093

Citation

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.

Results Reference

result

Learn more about this trial

Impact of Colchicine in Hospitalized Colombian Patients With COVID-19

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