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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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].


Condition or disease Intervention/treatment Phase
Coronavirus Infections Pneumonia, Viral Drug: Colchicine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Colchicine to Counteract Inflammatory Response in COVID-19 Pneumonia
Actual Study Start Date : April 20, 2020
Estimated Primary Completion Date : December 20, 2020
Estimated Study Completion Date : December 21, 2020


Arm Intervention/treatment
Experimental: Colchicine
Administration of Colchicine 1mg (or 0.5 mg in CKD)/day + standard of care for COVID-19 pneumonia
Drug: Colchicine
Cochicine 1mg/day

No Intervention: Standard of care
Standard of care for COVID-19 pneumonia



Primary Outcome Measures :
  1. 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

  2. Hospital discharge [ Time Frame: Day 28 ]
    Live discharge from the hospital (whatever comes first)


Secondary Outcome Measures :
  1. Death [ Time Frame: Day 28 ]
    Number of death patients

  2. Clinical status [ Time Frame: Day 7, Day 14 ]
    7-category ordinal scale

  3. Mechanical ventilhation [ Time Frame: Day 28 ]
    Number of patients with mechanical ventilhation

  4. Hospitalization [ Time Frame: Day 28 ]
    Days of hospitalization

  5. Time from treatment initiation to death [ Time Frame: Day 28 ]
    Days to death from treatment initiation

  6. Time to Negativization COVID 19 [ Time Frame: Day 21 ]
    negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart

  7. Fever [ Time Frame: Day 1,4,7,14,21,28 ]
    Time to remission of fever in patients with T>37.5°C at enrollment



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT04322565


Contacts
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Contact: Umberto Maggiore, MD 00390521904760 umberto.maggiore@unipr.it
Contact: Lucio Manenti, MD 00390521702013 lmanenti@ao.pr.it

Locations
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Italy
Azienda Ospedaliero Universitaria di Parma Recruiting
Parma, PR, Italy, 43100
Contact: Umberto Maggiore, MD    0521702009    umaggiore@ao.pr.it   
Contact: MD         
Sub-Investigator: Giuseppe Maglietta, PhD         
Sub-Investigator: Caterina Caminiti, PhD         
Sub-Investigator: Lucio Manenti, MD         
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria di Parma
Investigators
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Principal Investigator: Umberto Maggiore, MD Azienda Ospedaliero-Universitaria di Parma
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Responsible Party: Umberto Maggiore, MD, Azienda Ospedaliero-Universitaria di Parma
ClinicalTrials.gov Identifier: NCT04322565    
Other Study ID Numbers: ColCOVID-19
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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

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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
Keywords provided by Umberto Maggiore, Azienda Ospedaliero-Universitaria di Parma:
Colchicine
Corona Virus Infection
COVID-19
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents