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

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ClinicalTrials.gov Identifier: NCT04375202

Recruitment Status : Recruiting

First Posted : May 5, 2020

Last Update Posted : September 28, 2021

See Contacts and Locations

Sponsor:

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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	308 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
Estimated Primary Completion Date :	October 31, 2022
Estimated Study Completion Date :	October 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019)

Drug Information available for: Colchicine

U.S. FDA Resources

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 :

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 :

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

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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

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): NCT04375202

Locations

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Italy
Associazione Italiana Pneumologi Ospedalieri	Recruiting
Milan, Italy
Contact: Claudia Diana +39 0236590350 aipocentrostudi@aiporicerche.it
Società Italiana di Reumatologia	Recruiting
Milan, Italy
Contact: Carlo Scirè +390265560677 centrostudisir@reumatologia.it

Sponsors and Collaborators

University Of Perugia

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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. Review.

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:CD015045. doi: 10.1002/14651858.CD015045. Review.

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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 Key Record Dates
Last Update Posted:	September 28, 2021
Last Verified:	September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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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:

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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

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