A Phase 2 interventional study of Colchicine in Coronavirus Infections and Pneumonia, Viral, sponsored by Azienda Ospedaliero-Universitaria di Parma. Completed at 1 site in Italy. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-07-20.
Sponsored by Azienda Ospedaliero-Universitaria di Parma · Phase 2, Interventional, and Treatment
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].
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 193 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Azienda Ospedaliero-Universitaria di Parma is the lead sponsor of 43 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Administration of Colchicine 1mg (or 0.5 mg in CKD)/day + standard of care for COVID-19 pneumonia
Drug: Colchicine
Standard of care for COVID-19 pneumonia
Cochicine 1mg/day
Clinical improvement
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
Time frame: Day 28
Hospital discharge
Live discharge from the hospital (whatever comes first)
Time frame: Day 28
Death
Number of death patients
Time frame: Day 28
Clinical status
7-category ordinal scale
Time frame: Day 7, Day 14
Mechanical ventilhation
Number of patients with mechanical ventilhation
Time frame: Day 28
Hospitalization
Days of hospitalization
Time frame: Day 28
Time from treatment initiation to death
Days to death from treatment initiation
Time frame: Day 28
Time to Negativization COVID 19
negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart
Time frame: Day 21
Fever
Time to remission of fever in patients with T\>37.5°C at enrollment
Time frame: Day 1,4,7,14,21,28
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliero-Universitaria di Parma