Clinical trial NCT05463393: Xanthohumol as an Adjuvant Therapy in Critically Ill COVID-19 Patients
Official title: Humulus Lupus Extract Rich in Xanthohumol Improves Clinical Course in Critically Ill COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: EARLY_PHASE1
Conditions: COVID-19 Respiratory Infection
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patients were randomized in a double-blind, placebo-controlled fashion into two groups using sealed envelopes
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Xanthohumol reduces coronavirus-induced inflammatory response
timeFrame: one week after regular supplementation
measure: Xanthohumol improves clinical course in critically ill COVID-19 patients
timeFrame: 28 days mortality
Secondary outcomes:
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: Medical University of Lublin
Study officials:
affiliation: Rector of the Medical University of Lublin, Poland
name: Andrzej Stepulak, Prof
role: STUDY_DIRECTOR
References: