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

Adv Ther. 2022 Jun;39(6):3011-3018. doi: 10.1007/s12325-022-02135-z. Epub 2022 Apr 13.

Abstract

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 < 0.0001).

Conclusion: These exploratory data suggest the potential for ELOM-080 to improve respiratory status during and after hospitalisation in patients with COVID-19.

Keywords: COVID-19; Dyspnoea; ELOM-080; MCC enhancement; Mucociliary clearance; Shortness of breath.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • COVID-19* / complications
  • Double-Blind Method
  • Dyspnea / drug therapy
  • Dyspnea / etiology
  • Humans
  • Prospective Studies
  • Respiratory Insufficiency* / drug therapy
  • SARS-CoV-2
  • Treatment Outcome