NCT04375202

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
227

participants targeted

Target at P50-P75 for phase_2 covid19

Timeline
Completed

Started Apr 2020

Longer than P75 for phase_2 covid19

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

1.5 years

First QC Date

April 29, 2020

Last Update Submit

November 2, 2022

Conditions

COVID-19

Keywords

COVIDCOVID-19CORONAVIRUSSARS-COV-2COLCHICINEIL-1

Outcome Measures

Primary Outcomes (1)

  • Rate of entering the critical stage

    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 Outcomes (4)

  • Trend of White blood cell count

    [up to 30 days]

  • Change of the "Sequential Organ failure Assessment" (SOFA)

    [up to 30 days]

  • Rate of biochemical criterion (CK, ALT, ferritin) recovery

    [up to 30 days]

  • Rate of disease remission

    [up to 30 days]

Study Arms (2)

Colchicine plus current care

EXPERIMENTAL

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

Current care alone

NO INTERVENTION

Current care

Interventions

Colchicine 1 MG Oral TabletDRUG

Tablets for oral administration, containing 1 mg of the active ingredient colchicine, administered 0.5 mg po every 8 hours x 30 days.

Colchicine plus current care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Associazione Italiana Pneumologi Ospedalieri

Milan, Italy

Location

Società Italiana di Reumatologia

Milan, Italy

Location

Related Publications (2)

  • 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.

    PMID: 32317220BACKGROUND

  • 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.

    PMID: 34658014DERIVED

Related Links

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 5, 2020

Study Start

April 18, 2020

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

November 7, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)