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

November 2, 2022 updated by: Prof Roberto Gerli, University Of Perugia

Treatment With COLchicine of Patients Affected by COVID-19: a Pilot Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

227

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy
        • Associazione Italiana Pneumologi Ospedalieri
      • Milan, Italy
        • Società Italiana di Reumatologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
[1 month]

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Of Perugia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2020

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

October 31, 2021

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

May 3, 2020

First Posted (Actual)

May 5, 2020

Study Record Updates

Last Update Posted (Actual)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-001475-33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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