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Colchicine Twice Daily During 10 Days as an Option for the Treatment of Symptoms Induced by Inflammation in Patients With Mild and Severe Coronavirus Disease (ColchiVID)

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ClinicalTrials.gov Identifier: NCT04367168
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Condition or disease Intervention/treatment Phase
COVID Drug: Colchicine Drug: Placebo oral tablet Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 27, 2020
Estimated Primary Completion Date : April 27, 2021
Estimated Study Completion Date : April 27, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

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 Name: 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 Name: Armstrong




Primary Outcome Measures :
  1. Number of patients with improvement in body temperature, myalgia, arthralgia, total lymphocyte count, D-dimer, fibrinogen and ferritin levels [ Time Frame: Up to 24 days ]
    Resolution of fever, myalgia and arthralgia and 50% improvement of total lymphocyte count, D-dimer, fibrinogen and ferritin

  2. Progression to severe disease [ Time Frame: Up to 10 days ]
    At least one of the following: respiratory failure, respiratory rate > 30 rpm, oxygen saturation < 92%, PaO2/FiO2 < 300 mmHg



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT04367168


Contacts
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Contact: José J Torres-Ruiz, MD, MSc +521 5556555954 ext 4301 josetorresruiz85@gmail.com
Contact: Marina Rull-Gabayet, MD +521 5556555954 ext 4301 rull.marina@gmail.com

Locations
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Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Recruiting
Mexico City, Mexico, 14080
Contact: Jose J Torres-Ruiz, MD, MSc    54870900 ext 4301    josetorresruiz85@gmail.com   
Contact: Marina Rull, MD    54870900 ext 4301    rull.marina@gmail.com   
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
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Principal Investigator: José J Torres-Ruiz, MD, MSc Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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Responsible Party: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT04367168    
Other Study ID Numbers: 337420-21-1
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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

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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
Keywords provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Colchicine
Coronavirus
Inflammation
Cytokine storm
Clots
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents