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

• Published in: Advances in therapy 2022-06, Vol.39 (6), p.3011-3018
• Main Authors: Dreher, Michael, Grohè, Christian, Hartmann, Niels-Ulrik, Kanzler, Stephan, Kraft, Karin, Sarrazin, Christoph, Doll, Michael, Spiesshöfer, Jens, Steiner, Stephan, Wöhrle, Jochen, Seeger, Julia, Röschmann-Doose, Kristina, Thomsen, Jörn, Wittig, Thomas, Marx, Nikolaus, Eisenmann, Stephan
• Format: Article
• Language: English
• Subjects: Brief Report; Cardiology; COVID-19 - complications; Double-Blind Method; Dyspnea - drug therapy; Dyspnea - etiology; Endocrinology; Humans; Internal Medicine; Medicine; Medicine & Public Health; Oncology; Pharmacology/Toxicology; Prospective Studies; Respiratory Insufficiency - drug therapy; Rheumatology; SARS-CoV-2; Treatment Outcome
• ISSN: 0741-238X; 1865-8652; 1865-8652
• DOI: 10.1007/s12325-022-02135-z

Introduction 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. Patients/Methods 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. Results 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