Official Title
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].

Completed
Coronavirus Infections
Pneumonia, Viral

Drug: Colchicine

Cochicine 1mg/day

Eligibility 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 100 Years
Countries
Italy
Locations

Azienda Ospedaliero Universitaria di Parma
Parma, PR, Italy

Umberto Maggiore, MD, Principal Investigator
Azienda Ospedaliero-Universitaria di Parma

Azienda Ospedaliero-Universitaria di Parma
NCT Number
Keywords
Colchicine
Corona virus infection
Covid-19
MeSH Terms
COVID-19
Pneumonia
Coronavirus Infections
Pneumonia, Viral
Colchicine