Conference Abstract | Volume 8, Abstract ELIC2025162 (Oral 022) | Published: 14 Aug 2025
Sylvanus Okogbenin1, Cyril Erameh1, Osahogie Edeawe1,2, Stephan Günther3,4, Michael Ramharter4,5, Mirjam Groger4,5,&
¹Irrua Specialist Teaching Hospital, Irrua, Edo State, Nigeria, 2Department of Pharmacology and Therapeutics, College of Medicine, Ambrose Alli University, Edo State, Nigeria, 3Department of Virology, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany, 4German Center for Infection Research (DZIF), Partner Site Hamburg–Lübeck–Borstel–Riems, Germany, 5Center of Tropical Medicine, Bernhard Nocht Institute for Tropical Medicine & I. Department of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
&Corresponding author: Mirjam Groger, Bernhard-Nocht Institute for Tropical Medicine, Hamburg, Germany, Email: mirjam.groger@ctm.bnitm.de
Received: 24 Mar 2025, Accepted: 09 Jul 2025, Published: 14 Aug 2025
Domain: Infectious Disease Epidemiology
Keywords: Lassa Fever, Viral Hemorrhagic Fever, Dexamethasone, Ribavirin, Phase II Clinical Trial
©Sylvanus Okogbenin et al. Journal of Interventional Epidemiology and Public Health (ISSN: 2664-2824). This is an Open Access article distributed under the terms of the Creative Commons Attribution International 4.0 License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Cite this article: Sylvanus Okogbenin et al., Safety and tolerability of dexamethasone combined with standard-of-care Ribavirin for the treatment of Lassa Fever: An open-label randomized controlled phase II clinical trial. Journal of Interventional Epidemiology and Public Health. 2025;8(Conf Proc 5):00022. https://doi.org/10.37432/JIEPH-CONFPRO5-00022
Lassa fever (LF) can progress to severe disease resulting in high mortality. Ribavirin is the standard-of-care antiviral therapy. Dexamethasone, a corticosteroid, modulates inflammation-mediated tissue damage. It is hypothesized that its addition to ribavirin may enhance the effectiveness of LF treatment. This phase II clinical trial evaluated its safety and tolerability.
This prospective, open-label, randomized controlled phase II clinical trial conducted at a reference hospital in Nigeria assessed the safety and tolerability of adjunct dexamethasone combined with ribavirin compared to ribavirin alone for the treatment of LF. Hospitalized adult participants with PCR-confirmed LF were eligible (n=21 per arm). Safety data were collected over a 10-day follow-up period. Preliminary data will be presented.
Recruitment began in February 2024. As of May 2025, 36 evaluable participants have been included, with 19 (53%) female and median age of 33.5 years (range 19–67). Among the 17 participants receiving ribavirin alone, 14 adverse events (AEs) were reported. Two were graded as severe, dyspnea and Lassa meningitis, both considered as complication of the disease and leading to participant withdrawal due to the need for concomitant steroid therapy. Additionally, one case of severe Lassa fever leading to death was reported as serious adverse event (SAE). Among the 19 participants receiving adjunct dexamethasone, 18 AEs were reported, mostly mild. No severe AEs or SAEs occurred. All participants in the dexamethasone arm completed the 10-day follow-up.
Preliminary findings suggest that adjunct dexamethasone therapy is safe and tolerable. The AE severity tended to be higher in the ribavirin-only arm. These events were attributed to LF progression, suggesting that dexamethasone may contribute to improved clinical outcomes. These results support the rationale for more extensive evaluation, potentially informing future treatment guidelines and expanding evidence-based options for LF management.
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