Colchicine in Patients With Mild and Severe Coronavirus Disease (ColchiVID)

Double-blind, Placebo-controlled Clinical Trial of the Use of Colchicine for the Management of Patients With Mild and Severe SARS-Cov2 Infection

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.

Study Overview

• Status: Terminated
• Conditions: COVID
• Intervention / Treatment: Drug: Colchicine; Drug: Placebo oral tablet

Detailed Description

This a placebo-controlled double-blind clinical trial to test the efficacy and security of colchicine 1.5 mg at day one followed by 0.5 mg BID to complete 10 days of treatment. The researchers will recruit patients 18-70 years of age who are hospitalized because of the diagnosis of mild or severe COVID-19. Patients will be randomized to receive one of the treatment arms, colchicine or placebo. The aim of the study is to evaluate if colchicine may be able to improve the outcomes in patients with mild and severe COVID-19. Patients will be followed-up during the entire hospitalization time and during convalescence. The importance of this intervention is highlighted because currently, there is not an effective treatment for the virus, nor for the prevention of the cytokine storm or the disseminated intravascular coagulation. Therefore, an early intervention to prevent the development of these complications would be valuable to prevent the morbi-morbidity secondary to severe and critical COVID-19

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 14080
    • Instituto Nacional de Ciencias Médicas y Nutrición

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 1. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Colchicine; Colchicine PO	Drug: Colchicine; Colchicine 1mg, 1 ½ pill in day 1 and ½ pill BID during 10 days in both mild and severe COVID-19; Other Names: Perrigo
Placebo Comparator: Placebo; Placebo PO	Drug: Placebo oral tablet; Placebo, 1 ½ pill in day 1 and ½ pill BID during 10 days in both mild and severe COVID-19; Other Names: Armstrong

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Investigators: Principal Investigator: José J Torres-Ruiz, MD, MSc, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2020
• Primary Completion (Actual): April 27, 2021
• Study Completion (Actual): August 16, 2021

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Inflammation; Coronavirus; Colchicine; Cytokine storm; Clots
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine
• Other Study ID Numbers: 337420-21-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: 6 months after publication of the clinical trial
• IPD Sharing Access Criteria: Reviewers of scientific journals and researchers who contact the principal researcher by e-mail
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No