Colchicine in Patients With Mild and Severe Coronavirus Disease

COVID Clinical Trial

— ColchiVID  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04367168
• Other study ID #: 337420-21-1
• Status: Terminated
• Phase: Phase 2
• Start date: May 27, 2020
• Est. completion date: August 16, 2021

Study information

• Verified date: August 2021
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 116
• Est. completion date: August 16, 2021
• Est. primary completion date: April 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID

Intervention

Drug:
• Colchicine
Colchicine 1mg, 1 ½ pill in day 1 and ½ pill BID during 10 days in both mild and severe COVID-19
• Placebo oral tablet
Placebo, 1 ½ pill in day 1 and ½ pill BID during 10 days in both mild and severe COVID-19

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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