NCT04322565

Colchicine Counteracting Inflammation in COVID-19 Pneumonia

Colchicine to Counteract Inflammatory Response in COVID-19 Pneumonia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Azienda Ospedaliero-Universitaria di Parma · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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 \[4\].

Conditions

• Coronavirus Infections
• Pneumonia, Viral

Interventions

Type	Name	Description
DRUG	Colchicine	Cochicine 1mg/day

Timeline

• Start date: 2020-04-20
• Primary completion: 2021-09-01
• Completion: 2021-10-01
• First posted: 2020-03-26
• Last updated: 2022-07-20

Locations

1 site across 1 country: Italy