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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 : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Prof Roberto Gerli, University Of Perugia

Study Description
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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 : June 30, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arms and Interventions
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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
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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

  5. Toxicity of Colchicine [ Time Frame: [up to 30 days] ]
    Rate of adverse events codified by Common Terminology Criteria for Adverse Events (CTCAE) v5.0


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
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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
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Additional Information:

Publications:

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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: May 5, 2020
Last Verified: May 2020
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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Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents