COVID-19 Respiratory Infection
Conditions
Brief summary
It has been well documented that coronavirus COVID-19 disease is associated with massive inflammatory response and cytokine storm. Several medications have been used to ameliorate COVID-19-related inflammation. Xanthohumol, a natural medication extracted from hop cones, possesses strong anti-inflammatory properties and can reduce the severity of inflammatory response. The aim of this study is to analyze the effect of Xanthohumol on clinical course, inflammatory response and outcome in patients admitted to the ICU due to COVID-related acute respiratory failure with an oxygenation index (PaO2/FiO2) less than 150.
Detailed description
Xanthohumol inhibits proinflammatory pathways in different independent mechanisms. Ir inhibits farnesoid X receptor activity, and reduces the synthesis and release of different proinflammatory cytokines such as IL-1β, IL-6, IL-8, IL-12p70, TNFα and interferon γ. The pathomechanism of its anti-inflammatory activity is associated with the suppression of nuclear factor-kappa B. Additionally, Xanthohumol inhibits inflammatory-induced endothelial disorders, which are associated with an improvement in blood velocity and a reduction in the risk of arterial thrombosis, especially in pulmonary arteries. An increase in proinflammatory release, known as cytokine storm, as well as increased incidences of vascular thrombosis, are observed in coronavirus infection. Hence, Xanthohumol may reduce the severity of the clinical course in COVID-19 patients.
Interventions
BIOLOGICALXanthohumol - prenylated chalcone extracted from female inflorescences of hop cones (Humulus lupus). Hop-RXn™, BioActive-Tech Ltd, Lublin, Poland; http://xanthohumol.com.pl/
The appropriate dose of Xanthohumol was solved in 1 mL of propylene glycol
Sponsors
Medical University of Lublin
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
Patients were randomized in a double-blind, placebo-controlled fashion into two groups using sealed envelopes
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical diagnosis of COVID-19 with acute respiratory failure (PaO2/FiO2 below 150).
Exclusion criteria
History of chronic cardiovascular, liver or/and kidney diseases. History of chronic pulmonary diseases with prolonged oxygen supplementation or domestic mechanical ventilation. Pregnant women, Neoplastic diseases, Immunologic diseases Patients received immunomodulatory treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Xanthohumol reduces coronavirus-induced inflammatory response | one week after regular supplementation | Xanthohumol possesses strong anti-inflammatory properties. It can reduce the production and secretion of pro-inflammatory cytokines. Additionally, it inhibits inflammatory-induced endothelial dysregulation and exerting antiangiogenic and anti-inflammatory effects. |
| Xanthohumol improves clinical course in critically ill COVID-19 patients | 28 days mortality | Reduction the severity of inflammatory response should affect clinical course. Strong anti-inflammatory treatment can reduce a risk of poor outcome. |
Countries
Poland
Outcome results
None listed