Xanthohumol as an Adjuvant Therapy in Critically Ill COVID-19 Patients

NCT05463393 | Suspended Early Phase 1

• 1 other identifier: DS352/2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Respiratory Infection

Outcome Measures

Primary Outcomes (2)

• Xanthohumol reduces coronavirus-induced inflammatory response

  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.

  one week after regular supplementation

• Xanthohumol improves clinical course in critically ill COVID-19 patients

  Reduction the severity of inflammatory response should affect clinical course. Strong anti-inflammatory treatment can reduce a risk of poor outcome.

  28 days mortality

Study Arms (2)

Group Xn

EXPERIMENTAL

Patients who received extract from Humulus lupus L rich in Xanthohumol (Hop-RXn™, BioActive-Tech Ltd, Lublin, Poland; http://xanthohumol.com.pl/) as an adjuvant therapy. Based on pharmacokinetics and bioactivity, Xn was administered enterally three times a day every 8 hours at a dose of 1.5 mg/kg body weight (4.5 mg/kg body weight/day) for 7 days. The first dose of Xn was administered within 4 hours after admission to the ICU.

Biological: Xanthohumol - prenylated chalcone extracted from female inflorescences of hop cones (Humulus lupus). Hop-RXn™, BioActive-Tech Ltd, Lublin, Poland; http://xanthohumol.com.pl/

Group C

PLACEBO COMPARATOR

Patients who received 0.9% NaCl at the oral volume 1 mL (similar to Xn volume) three times a day every 8 hours. The first dose of Xn was administered within 4 hours after admission to the ICU.

Biological: Xanthohumol - prenylated chalcone extracted from female inflorescences of hop cones (Humulus lupus). Hop-RXn™, BioActive-Tech Ltd, Lublin, Poland; http://xanthohumol.com.pl/

Interventions

Xanthohumol - prenylated chalcone extracted from female inflorescences of hop cones (Humulus lupus). Hop-RXn™, BioActive-Tech Ltd, Lublin, Poland; http://xanthohumol.com.pl/ BIOLOGICAL

The appropriate dose of Xanthohumol was solved in 1 mL of propylene glycol

Group C; Group Xn

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of COVID-19 with acute respiratory failure (PaO2/FiO2 below 150).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Lublin: lead

Study Sites (1)

Medical University of Lublin

Lublin, 20-059, Poland

Location

Study Officials

• Andrzej Stepulak, Prof

  Rector of the Medical University of Lublin, Poland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof MD PhD, Head of Chair and First Department of Anaesthesiology and Intensive Therapy

Model Details: Patients were randomized in a double-blind, placebo-controlled fashion into two groups using sealed envelopes

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 19, 2022
• Study Start: October 1, 2020
• Primary Completion: January 30, 2022
• Study Completion: December 31, 2025
• Last Updated: July 1, 2025

Record last verified: 2024-12

Locations

PL (1)