Colchicine in Patients With Mild and Severe Coronavirus Disease

NCT04367168 | Terminated Phase 2 DMC

• 1 other identifier: 337420-21-1
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The world is currently facing a pandemic due to the outbreak of a new coronavirus causing acute respiratory failure called SARS-Cov2. The majority of patients (8 out of 10) are known to have mild disease, manifested by respiratory tract symptoms associated with fever, headache, and body pain. However, it is possible that the disease progresses to a severe stage, whith the need for mechanical ventilation support associated with high morbidity and mortality. The progression of the disease is mainly due to the appearance of uncontrolled inflammation that also favors the development of disseminated clots. So far, there is no effective treatment to combat coronavirus; however, the use of anti-inflammatory drugs is potentially effective in preventing complications from the disease. In this regard, low dose colchicine is relatively safe and effective as an anti-inflammatory. It has been used for many years in the control of inflammation secondary to the accumulation of uric acid crystals. The aim of this study is to test if the administration of colchicine at a dose of 1.5 mg the first day and subsequently 0.5 mg BID until completing 10 days of treatment is effective as a treatment for inflammation related symptoms in patients with mild and severe disease secondary to coronavirus infection. The primary outcome is improvement of symptoms related to inflammation and avoiding progression to severe and critical stages of the disease. Colchicine can be discontinued before the end of 10 days in case of serious adverse effects or if the patient progresses to the critical stages of the disease.

Conditions

COVID

Keywords

Colchicine; Coronavirus; Inflammation; Cytokine storm; Clots

Outcome Measures

Primary Outcomes (2)

• Number of patients with improvement in body temperature, myalgia, arthralgia, total lymphocyte count, D-dimer, fibrinogen and ferritin levels

  Resolution of fever, myalgia and arthralgia and 50% improvement of total lymphocyte count, D-dimer, fibrinogen and ferritin

  Up to 24 days

• Progression to severe disease

  At least one of the following: respiratory failure, respiratory rate \> 30 rpm, oxygen saturation \< 92%, PaO2/FiO2 \< 300 mmHg

  Up to 10 days

Study Arms (2)

Colchicine

ACTIVE COMPARATOR

Colchicine PO

Drug: Colchicine

Placebo

PLACEBO COMPARATOR

Placebo PO

Drug: Placebo oral tablet

Interventions

Colchicine DRUG

Colchicine 1mg, 1 ½ pill in day 1 and ½ pill BID during 10 days in both mild and severe COVID-19

Also known as: Perrigo

Colchicine

Placebo oral tablet DRUG

Placebo, 1 ½ pill in day 1 and ½ pill BID during 10 days in both mild and severe COVID-19

Also known as: Armstrong

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age
• Diagnosed with COVID-19 with mild or severe disease
• Who must receive in-hospital care at the Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Who are able to take pills PO

You may not qualify if:

• \. Concomitant participation in another clinical trial. 2. Hypersensitivity to colchicine 3. Pregnancy and lactation 4. Over 70 years 5. Kidney failure with creatinine clearance \<30 mL / min. 6. Known liver failure 7. Concomitant medication that has interactions with colchicine and that due to its indication cannot be suspended or substituted

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion

Mexico City, 14080, Mexico

Location

Related Publications (1)

• Absalon-Aguilar A, Rull-Gabayet M, Perez-Fragoso A, Mejia-Dominguez NR, Nunez-Alvarez C, Kershenobich-Stalnikowitz D, Sifuentes-Osornio J, Ponce-de-Leon A, Gonzalez-Lara F, Martin-Nares E, Montesinos-Ramirez S, Ramirez-Alemon M, Ramirez-Rangel P, Marquez MF, Plata-Corona JC, Juarez-Vega G, Gomez-Martin D, Torres-Ruiz J. Colchicine Is Safe Though Ineffective in the Treatment of Severe COVID-19: a Randomized Clinical Trial (COLCHIVID). J Gen Intern Med. 2022 Jan;37(1):4-14. doi: 10.1007/s11606-021-07203-8. Epub 2021 Nov 9.

  PMID: 34755269 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; Inflammation; Cytokine Release Syndrome

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Shock

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• José J Torres-Ruiz, MD, MSc

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind placebo-controlled clinical trial to test the security and efficacy of colchicine at a dose of 1.5 mg PO at day 1 followed by 0.5 mg PO BID to complete 10 days of treatment

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 29, 2020
• Study Start: May 27, 2020
• Primary Completion: April 27, 2021
• Study Completion: August 16, 2021
• Last Updated: August 10, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after publication of the clinical trial
• Access Criteria: Reviewers of scientific journals and researchers who contact the principal researcher by e-mail

Locations

ME (1)