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Completed

NCT Number: NCT04322565

Colchicine Counteracting Inflammation in COVID-19 Pneumonia

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].

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Key information

Conditions

Coronavirus Infections COVID-19 Coronaviridae Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Azienda Ospedaliero Universitaria di Parma

Parma, PR, 43100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colchicine

Drug

Cochicine 1mg/day

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria di Parma

Other

Registry information

Official study title

Colchicine to Counteract Inflammatory Response in COVID-19 Pneumonia

Acronym: ColCOVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 26, 2020
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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