Efficacy and Safety of ELOM-080 as Add-On Therapy in COVID-19 Patients with Acute Respiratory Insufficiency: Exploratory Data from the Prospective Placebo-Controlled COVARI Trial.
COVID-19
Dyspnoea
ELOM-080
MCC enhancement
Mucociliary clearance
Shortness of breath
Journal
Advances in therapy
ISSN: 1865-8652
Titre abrégé: Adv Ther
Pays: United States
ID NLM: 8611864
Informations de publication
Date de publication:
06 2022
06 2022
Historique:
received:
22
02
2022
accepted:
16
03
2022
pubmed:
15
4
2022
medline:
25
5
2022
entrez:
14
4
2022
Statut:
ppublish
Résumé
Enhancement of mucociliary clearance (MCC) might be a potential target in treating COVID-19. The phytomedicine ELOM-080 is an MCC enhancer that is used to treat inflammatory respiratory diseases. This randomised, double-blind exploratory study (EudraCT number 2020-003779-17) evaluated 14 days' add-on therapy with ELOM-080 versus placebo in patients with COVID-19 hospitalised with acute respiratory insufficiency. The trial was terminated early after enrolment of 47 patients as a result of poor recruitment. Twelve patients discontinued prematurely, leaving 35 in the per-protocol set (PPS). Treatment with ELOM-080 had no significant effect on overall clinical status versus placebo (p = 0.49). However, compared with the placebo group, patients treated with ELOM-080 had less dyspnoea in the second week of hospitalisation (p = 0.0035), required less supplemental oxygen (p = 0.0229), and were more often without dyspnoea when climbing stairs at home (p < 0.0001). These exploratory data suggest the potential for ELOM-080 to improve respiratory status during and after hospitalisation in patients with COVID-19.
Identifiants
pubmed: 35419650
doi: 10.1007/s12325-022-02135-z
pii: 10.1007/s12325-022-02135-z
pmc: PMC9007397
doi:
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Pagination
3011-3018Informations de copyright
© 2022. The Author(s).
Références
Robinot R, Hubert M, Dias de Melo G, et al. SARS-CoV-2 infection induces the dedifferentiation of multiciliated cells and impairs mucociliary clearance. Nat Commun. 2021;12:1–16.
doi: 10.1038/s41467-021-24521-x
Wittig T. Mucociliary clearance in COVID-19-an underestimated danger area in early phase of disease? MMW Fortschr Med. 2021;163:21–7.
doi: 10.1007/s15006-021-0189-9
Crook H, Raza S, Nowell J, Young M, Edison P. Long covid—mechanisms, risk factors, and management. Br Med J. 2021;374. https://doi.org/10.1136/bmj.n1648 .
Mandal S, et al. ‘Long-COVID’: a cross-sectional study of persisting symptoms, biomarker and imaging abnormalities following hospitalisation for COVID-19. Thorax. 2021;76:396–8.
doi: 10.1136/thoraxjnl-2020-215818
Fürst R, Luong B, Thomsen J, Wittig T. ELOM-080 as add-on treatment for respiratory tract diseases—a review of clinical studies conducted in China. Planta Med. 2019;85:745–54.
doi: 10.1055/a-0942-1993
Lai Y, et al. In vitro studies of a distillate of rectified essential oils on sinonasal components of mucociliary clearance. Am J Rhinol Allergy. 2014;28:244–8.
doi: 10.2500/ajra.2014.28.4036
Begrow F, Böckenholt C, Ehmen M, Wittig T, Verspohl EJ. Effect of myrtol standardized and other substances on the respiratory tract: ciliary beat frequency and mucociliary clearance as parameters. Adv Ther. 2012;29:350–8. https://doi.org/10.1007/s12325-012-0014-z .
doi: 10.1007/s12325-012-0014-z
pubmed: 22477544
Christoph F, Kaulfers PM, Stahl-Biskup E. In vitro evaluation of the antibacterial activity of beta-triketones admixed to Melaleuca oils. Planta Med. 2001;67:768–71. https://doi.org/10.1055/s-2001-18350 .
doi: 10.1055/s-2001-18350
pubmed: 11731927
Gillissen A, Wittig T, Ehmen M, Krezdorn HG, de Mey C. A multi-centre, randomised, double-blind, placebo-controlled clinical trial on the efficacy and tolerability of GeloMyrtol
doi: 10.1055/s-0032-1331182
Meister R, Wittig T, Beuscher N, de Mey C. Efficacy and tolerability of myrtol standardized in long-term treatment of chronic bronchitis. A double-blind, placebo-controlled study Study Group Investigators. Arzneimittelforschung. 1999;49:351–8. https://doi.org/10.1055/s-0031-1300426 .
doi: 10.1055/s-0031-1300426
pubmed: 10337455
Matthys H, et al. Efficacy and tolerability of myrtol standardized in acute bronchitis. A multi-centre, randomised, double-blind, placebo-controlled parallel group clinical trial vs. cefuroxime and ambroxol. Arzneimittelforschung. 2000;50:700–11. https://doi.org/10.1055/s-0031-1300276 .
doi: 10.1055/s-0031-1300276
pubmed: 10994153
Wittig T. Myrtol standardized: a clinical documentation. Hamburg: Ergebnisse-Verlag; 2005.
Kluge S, et al. S2k-Leitlinie–Empfehlungen zur stationären Therapie von Patienten mit COVID-19. Pneumologie. 2021;75:88–112.
doi: 10.1055/a-1334-1925
Marshall JC, et al. A minimal common outcome measure set for COVID-19 clinical research. Lancet Infect Dis. 2020;20:e192–7.
doi: 10.1016/S1473-3099(20)30483-7
Desai A, Gyawali B. Endpoints used in phase III randomized controlled trials of treatment options for COVID-19. EClinicalMedicine. 2020;23:100403.
doi: 10.1016/j.eclinm.2020.100403
Hirt J, et al. Clinical trial research on COVID-19 in Germany—a systematic analysis. F1000Research. 2021;10:913.
doi: 10.12688/f1000research.55541.1
Karagiannidis C, et al. Case characteristics, resource use, and outcomes of 10 021 patients with COVID-19 admitted to 920 German hospitals: an observational study. Lancet Respir Med. 2020;8:853–62.
doi: 10.1016/S2213-2600(20)30316-7
Li YY, et al. Myrtol standardized affects mucociliary clearance. Int Forum Allergy Rhinol. 2017;7:304–11. https://doi.org/10.1002/alr.21878 .
doi: 10.1002/alr.21878
pubmed: 27888644
Thomas M, Price OJ, Hull JH. Pulmonary function and COVID-19. Curr Opin Physiol. 2021;21:29–35.
doi: 10.1016/j.cophys.2021.03.005