Trial reportAdvances in therapy2025
Randomised, Placebo-Controlled, Double-Blind Trial to Assess Efficacy and Safety of ELOM-080 in Outpatients with COVID-19.
Trial report in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Who cites it
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionIncidences of infections with Severe Acute Respiratory Syndrome Coronavirus type 2 (SARS-CoV-2) are still high and treatment guidelines lack specific recommendations for outpatients with Coronavirus-induced disease 2019 (COVID-19). Phytomedicine ELOM-080, an enhancer of mucociliary clearance (MCC), showed benefits as add-on therapy in hospitalised COVID-19 patients.
methodsThis randomised, double-blind, placebo-controlled proof-of-concept study investigated whether outpatients with mild to moderate acute symptomatic COVID-19 would benefit from a 14-day treatment with ELOM-080 with regard to potential early treatment effects on cough and further typical COVID-19 symptoms. Outpatients with mild to moderate acute symptomatic COVID-19 documented symptom severity and count of coughs on a daily basis. Investigators documented safety and symptom severity during the visits.
resultsThis study missed its primary objective, which was reduction in coughing fits in comparison to placebo treatment. In primary analysis, no relevant differences were observed between treatment arms. Data for all randomised patients showed broad heterogeneity in, e.g., time courses of coughing fits, which affected both magnitude and timing of the changes from baseline. However, post hoc analyses with a population with suspected dysfunctional MCC revealed that patients significantly benefitted from treatment with ELOM-080 in terms of reduction in coughing fits (p = 0.0070), difficulty breathing on exertion (p = 0.0252), and earlier remission of symptoms by 1-3 days.
conclusionWe have shown that patients with dysfunctional MCC benefit from treatment with ELOM-080. These results might be of clinical importance, as up to now no therapy has obtained market approval for the treatment of outpatients with COVID-19.
trial registrationEudraCT number: 2022-003478-22.
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