Page 44 - JCTR-11-3
P. 44

Journal of Clinical and

                                                                  Translational Research



                                        REVIEW ARTICLE
                                        Greek poplar-type propolis as an adjunct

                                        therapy in hospitalized COVID-19 adults:
                                        A randomized controlled trial protocol



                                        Giorgos Tzigkounakis *  and Jonathan Brown 2
                                                           1
                                        1 Department of Research, Health and Resilience Institute, Athens, Greece
                                        2 Department of Nutrition, Food and Exercise Sciences, Faculty of Health and Medical Sciences,
                                        University of Surrey, Guildford, Surrey, United Kingdom




                                        Abstract

                                        Background: Despite the rapid development and distribution of COVID-19 vaccines,
                                        the pandemic continues to challenge global health systems. With vaccine inequity
                                        and hesitancy, especially in low-income populations and specific demographic
                                        cohorts, alternative therapeutic strategies to mitigate COVID-19 symptoms and
                                        reduce viral  clearance time  remain  vital.  Propolis,  a natural bee product  with
                                        immunomodulatory and antiviral properties, has demonstrated efficacy against
                                        other viral pathogens, suggesting potential as an adjunctive therapy for COVID-19.
            *Corresponding author:      Objectives:  This study  protocol  outlines  a randomized,  triple-blind,  placebo-
            Giorgos Tzigkounakis        controlled clinical trial to assess the efficacy of a Greek propolis hydroalcoholic
            (info@healthandresilience.org)  extract  as  an adjunct  to standard  care in hospitalized  COVID-19  patients.  The
            Citation: Tzigkounakis G, Brown J.   primary objectives are to evaluate the extract’s impact on viral clearance time and
            Greek poplar-type propolis as an   hospitalization duration, with secondary objectives examining body temperature,
            adjunct therapy in hospitalized
            COVID-19 adults: A randomized   cough severity, quality of life, and safety. Methods: A total of 441 severe acute
            controlled trial protocol. J Clin   respiratory syndrome coronavirus 2-positive adult patients will be enrolled and
            Transl Res. 2025;11(3):38-49.   stratified by age and vaccination status. Participants will be randomly assigned to
            doi: 10.36922/jctr.24.00073
                                        one of three arms: (i) propolis extract, (ii) placebo, or (iii) control (standard care
            Received: October 30, 2024  only). Primary outcomes include time to negative reverse transcription polymerase
            1st revised: January 12, 2025  chain reaction tests and hospital discharge. Secondary measures involve cough
                                        severity and quality-of-life assessments through Visual Analog Scale and Leicester
            2nd revised: March 11, 2025
                                        Cough Questionnaire scores, fever duration and resolution patterns, and safety
            Accepted: March 26, 2025    through adverse events and mortality tracking. Statistical analysis will include
            Published online: May 16, 2025  Kaplan–Meier survival curves, Cox regression for confounders, and analysis of
                                        variance for quality-of-life scores. Conclusion:  This study aims to validate the
            Copyright: © 2025 Author(s).
            This is an Open-Access article   therapeutic potential of propolis as a natural, accessible adjunctive treatment for
            distributed under the terms of the   COVID-19. Findings may provide critical evidence supporting propolis in symptom
            Creative Commons AttributionNon-  relief, viral clearance, and healthcare burden reduction in resource-limited settings.
            Commercial 4.0 International (CC
            BY-NC 4.0), which permits all   Relevance for patients: Participants in  the intervention arm  may  experience
            non-commercial use, distribution,   improved clinical outcomes, such as faster recovery and symptom alleviation,
            and reproduction in any medium,   while all patients will continue to receive standard care in alignment with current
            provided the original work is
            properly cited.             clinical protocols.
            Publisher’s Note: AccScience
            Publishing remains neutral with   Keywords: SARS-CoV-2; COVID-19; Propolis; Adjunct therapy; Nutraceuticals;
            regard to jurisdictional claims in
            published maps and institutional   Randomized controlled trial; Immune modulation
            affiliations.


            Volume 11 Issue 3 (2025)                        38                            doi: 10.36922/jctr.24.00073
   39   40   41   42   43   44   45   46   47   48   49