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Colchicine Counteracting Inflammation in COVID-19 Pneumonia (ColCOVID-19)

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ClinicalTrials.gov Identifier: NCT04322565
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Umberto Maggiore, Azienda Ospedaliero-Universitaria di Parma

Tracking Information
First Submitted Date  ICMJE March 24, 2020
First Posted Date  ICMJE March 26, 2020
Last Update Posted Date July 10, 2020
Actual Study Start Date  ICMJE April 20, 2020
Estimated Primary Completion Date December 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
  • Clinical improvement [ Time Frame: Day 28 ]
    Time to clinical improvement: defined as time from randomization to an improvement of two points from the status at randomization on a seven-category ordinary scale
  • Hospital discharge [ Time Frame: Day 28 ]
    Live discharge from the hospital (whatever comes first)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
  • Death [ Time Frame: Day 28 ]
    Number of death patients
  • Clinical status [ Time Frame: Day 7, Day 14 ]
    7-category ordinal scale
  • Mechanical ventilhation [ Time Frame: Day 28 ]
    Number of patients with mechanical ventilhation
  • Hospitalization [ Time Frame: Day 28 ]
    Days of hospitalization
  • Time from treatment initiation to death [ Time Frame: Day 28 ]
    Days to death from treatment initiation
  • Time to Negativization COVID 19 [ Time Frame: Day 21 ]
    negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart
  • Fever [ Time Frame: Day 1,4,7,14,21,28 ]
    Time to remission of fever in patients with T>37.5°C at enrollment
Original Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
  • Death [ Time Frame: Day 28 ]
  • Clinical status [ Time Frame: Day 4, 7, Day 14, Day 21 ]
    7-category ordinal scale
  • Mechanical venhtilation [ Time Frame: Day 28 ]
  • Hospitalization [ Time Frame: Day 28 ]
  • Time from death [ Time Frame: Day 28 ]
  • Negativization COVID 19 [ Time Frame: Day 21 ]
    negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart
  • Fever [ Time Frame: Day 1,4,7,14,21,28 ]
    Time to remission of fever in patients with T>37.5°C at enrollment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Colchicine Counteracting Inflammation in COVID-19 Pneumonia
Official Title  ICMJE Colchicine to Counteract Inflammatory Response in COVID-19 Pneumonia
Brief Summary

Cytokines and chemokines are thought to play an important role in immunity and immunopathology during virus infections [3]. Patients with severe COVID-19 have higher serum levels of pro-inflammatory cytokines (TNF-α, IL-1 and IL-6) and chemokines (IL-8) compared to individuals with mild disease or healthy controls, similar to patients with SARS or MERS . The change of laboratory parameters, including elevated serum cytokine, chemokine levels, and increased NLR in infected patients are correlated with the severity of the disease and adverse outcome, suggesting a possible role for hyper-inflammatory responses in COVID-19 pathogenesis. Importantly, previous studies showed that viroporin E, a component of SARS-associated coronavirus (SARS-CoV), forms Ca2C-permeable ion channels and activates the NLRP3 inflammasome. In addition, another viroporin 3a was found to induce NLRP3 inflammasome activation . The mechanisms are unclear.

Colchicine, an old drug used in auto-inflammatory disorders (i.e., Familiar Mediterranean Fever and Bechet disease) and in gout, counteracts the assembly of the NLRP3 inflammasome, thereby reducing the release of IL-1b and an array of other interleukins, including IL-6, that are formed in response to danger signals. Recently, colchicine has been successfully used in two cases of life-threatening post-transplant capillary leak syndrome. These patients had required mechanically ventilation for weeks and hemodialysis, before receiving colchicine, which abruptly restored normal respiratory function and diuresis over 48 hrs [4].

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronavirus Infections
  • Pneumonia, Viral
Intervention  ICMJE Drug: Colchicine
Cochicine 1mg/day
Study Arms  ICMJE
  • Experimental: Colchicine
    Administration of Colchicine 1mg (or 0.5 mg in CKD)/day + standard of care for COVID-19 pneumonia
    Intervention: Drug: Colchicine
  • No Intervention: Standard of care
    Standard of care for COVID-19 pneumonia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 14, 2020)
310
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2020)
100
Estimated Study Completion Date  ICMJE December 21, 2020
Estimated Primary Completion Date December 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Positive nasopharyngeal swab for COVID-19, asymptomatic or paucisymptomatic, aged ≥70 years and/or with clinical risk factors for poor outcome (clinically relevant chronic lung disease, diabetes and/or heart disease) or
  • symptomatic with respiratory or systemic symptoms, however clinically stable (MEWS<3) with CT imaging showing viral pneumonia and positive or pending pharyngo-nasal swab for COVID-19: Temperature 38°C and/or intensive cough, Respiratory rate < 25 /min, oxygen saturation (pulse oximetry) >95%
  • Positive swab for COVID-19
  • with respiratory and/or systemic symptoms and initial mild respiratory failure e with objective signs of lung involvement; the patient is in stable conditions (MEWS < 3) Temperature>38°C and or intensive cough, Respiratory rate ≥25 /min, or oxygen saturation 94- 95% in room air

Exclusion Criteria:

  • Pregnant or breast feeding
  • MEWS >=3
  • Hepatic failure Child-Pugh C
  • Enrollment in other pharmacological studies
  • Ongoing treatment with colchicine
  • Ongoing treatment with antiviral drugs that include ritonavir or cobicistat
  • Any medical condition or disease which in the opinion of the Investigator may place the patient at unacceptable risk for study participation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Umberto Maggiore, MD 00390521904760 umberto.maggiore@unipr.it
Contact: Lucio Manenti, MD 00390521702013 lmanenti@ao.pr.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04322565
Other Study ID Numbers  ICMJE ColCOVID-19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data will be avaliable from July 2020 and documentation will be shared for 10 years
Access Criteria: The sponsor recognizes the importance of communicating study data and will disclose and publish the results in a suitable form regardless of outcome. The sponsor will publish the results of this study in scientific journals
Responsible Party Umberto Maggiore, Azienda Ospedaliero-Universitaria di Parma
Study Sponsor  ICMJE Azienda Ospedaliero-Universitaria di Parma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Umberto Maggiore, MD Azienda Ospedaliero-Universitaria di Parma
PRS Account Azienda Ospedaliero-Universitaria di Parma
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP