Colchicine in COVID-19: a Pilot Study (COLVID-19)

• ClinicalTrials.gov Identifier: NCT04375202
• Recruitment Status: Terminated
• First Posted: May 5, 2020
• Last Update Posted: November 7, 2022
• Sponsor: University Of Perugia
• Information provided by (Responsible Party): Prof Roberto Gerli, University Of Perugia

Study Description

Brief Summary:

This is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with COVID-19 disease. One-month rate of entering the critical stage (either a. Respiratory failure occurs and requires mechanical ventilation; b. Patients combined with other organ failure need ICU monitoring and treatment; c. Death) is the primary endpoint.

Condition or disease	Intervention/treatment	Phase
COVID-19	Drug: Colchicine 1 MG Oral Tablet	Phase 2

Detailed Description:

This is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with COVID-19 disease. Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care versus current care.

One-month rate of entering the critical stage (either a. Respiratory failure occurs and requires mechanical ventilation; b. Patients combined with other organ failure need ICU monitoring and treatment; c. Death) is the primary endpoint. Secondary objectives are trend of White blood cell count, Change of the "Sequential Organ failure Assessment" (SOFA), Rate of biochemical criterion (CK, ALT,ferritin) recovery, Rate of disease remission and safety of Colchicine.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 227 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment With COLchicine of Patients Affected by COVID-19: a Pilot Study
• Actual Study Start Date: April 18, 2020
• Actual Primary Completion Date: October 31, 2021
• Actual Study Completion Date: October 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Colchicine plus current care; Colchicine 0.5 mg three times a day if weight is less than 100 kg; 1 mg twice a day if weight is more than 100 kg for 30 days or up to discharge. Reduce based on gastrointestinal symptoms appearance at discretion of the Investigator.	Drug: Colchicine 1 MG Oral Tablet; Tablets for oral administration, containing 1 mg of the active ingredient colchicine, administered 0.5 mg po every 8 hours x 30 days.
No Intervention: Current care alone; Current care

Outcome Measures

Primary Outcome Measures :

1. Rate of entering the critical stage [ Time Frame: [1 month] ]

   Comply with any of the followings:

   1. Respiratory failure occurs and requires mechanical ventilation;
   2. Patients combined with other organ failure need ICU monitoring and treatment
   3. Death

Secondary Outcome Measures :

1. Trend of White blood cell count [ Time Frame: [up to 30 days] ]
2. Change of the "Sequential Organ failure Assessment" (SOFA) [ Time Frame: [up to 30 days] ]
3. Rate of biochemical criterion (CK, ALT, ferritin) recovery [ Time Frame: [up to 30 days] ]
4. Rate of disease remission [ Time Frame: [up to 30 days] ]

   Comply with any of the followings:

   1. No fever, cough and other symptoms;
   2. SPO2>94% or PaO2/FiO2 >350mmHg without oxygen inhalation

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Informed consent for participation in the study
• Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
• Hospitalized due to clinical/instrumental diagnosis of pneumonia
• Oxygen saturation at rest in ambient air ≤94%
• PaO2/FiO2 ratio of 350 to 200

Exclusion Criteria:

• Known hypersensitivity to colchicine or its excipients
• Severe diarrhea
• Patients who cannot take oral therapy
• Pregnant and lactating patients
• Patients with severe cardiac, renal insufficiency (creatinine clearance (CCL) <30 mL / min)
• Patients with kidney or liver damage [(AST or ALT> 5 times the normal limits in International Units (ULN)]; or are taking CYP3A4 enzyme - P glycoprotein inhibitors.
• Known other clinical condition that contraindicates colchicine and cannot be treated or solved according to the judgement of the clinician
• Neutrophils <1.000 / mmc
• Platelets <50.000 / mmc
• Bowel diverticulitis or perforation
• Patients already in ICU or requiring mechanical ventilation
• Patients receiving Tocilizumab
• Patients already enrolled in other clinical trials

Contacts and Locations

Locations

Italy

Associazione Italiana Pneumologi Ospedalieri

Milan, Italy

Società Italiana di Reumatologia

Milan, Italy

Sponsors and Collaborators

University Of Perugia

More Information

Additional Information:

Related Info 

Publications:

Perricone C, Triggianese P, Bartoloni E, Cafaro G, Bonifacio AF, Bursi R, Perricone R, Gerli R. The anti-viral facet of anti-rheumatic drugs: Lessons from COVID-19. J Autoimmun. 2020 Jul;111:102468. doi: 10.1016/j.jaut.2020.102468. Epub 2020 Apr 17.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.

• Responsible Party: Prof Roberto Gerli, Principal Investigator, University Of Perugia
• ClinicalTrials.gov Identifier: NCT04375202
• Other Study ID Numbers: 2020-001475-33
• First Posted: May 5, 2020
• Last Update Posted: November 7, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof Roberto Gerli, University Of Perugia:

COVID; COVID-19; CORONAVIRUS; SARS-COV-2; COLCHICINE; IL-1

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Colchicine; Gout Suppressants; Antirheumatic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents