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

June 26, 2025 updated by: Wojciech Dąbrowski, Medical University of Lublin

Humulus Lupus Extract Rich in Xanthohumol Improves Clinical Course in Critically Ill COVID-19 Patients

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Lublin, Poland, 20-059
        • Medical University of Lublin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group Xn
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/
The appropriate dose of Xanthohumol was solved in 1 mL of propylene glycol
Placebo Comparator: Group C
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/
The appropriate dose of Xanthohumol was solved in 1 mL of propylene glycol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Xanthohumol reduces coronavirus-induced inflammatory response
Time Frame: 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.
one week after regular supplementation
Xanthohumol improves clinical course in critically ill COVID-19 patients
Time Frame: 28 days mortality
Reduction the severity of inflammatory response should affect clinical course. Strong anti-inflammatory treatment can reduce a risk of poor outcome.
28 days mortality

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lublin

Investigators

  • Study Director: Andrzej Stepulak, Prof, Rector of the Medical University of Lublin, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

January 30, 2022

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 15, 2022

First Submitted That Met QC Criteria

July 15, 2022

First Posted (Actual)

July 19, 2022

Study Record Updates

Last Update Posted (Estimated)

July 1, 2025

Last Update Submitted That Met QC Criteria

June 26, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS352/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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