Adaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics.

The current recommendation for treating Lassa fever with ribavirin is supported only by weak evidence. Given the persistent effects in areas with endemic transmission and epidemic potential, there is an urgent need to reassess ribavirin and investigate other potential therapeutic candidates; however, a robust clinical trial method adapted to Lassa fever epidemiology has not yet been established. We propose an adaptive phase II/III multicenter randomized controlled platform trial that uses a superiority framework with an equal allocation ratio and accounts for challenges selecting the primary end point and estimating the target sample size by using an interim analysis.

Improving clinical care of patients in Nipah outbreaks: moving beyond 'compassionate use'.

The 2024 Nipah outbreak in Kerala, India-its fifth in six years-and the recurring annual outbreaks in Bangladesh underscore the persistent threat posed by the Nipah virus (NiV) in the region. With a high mortality rate, human-to-human transmission potential, and the widespread presence of bats, the natural reservoir, NiV remains a significant epidemic threat. Despite being a WHO priority pathogen, there has been no systematic effort to improve patient care for NiVD, leading to consistently poor outcomes.

Clinical characterisation and outcomes of human clade IIb mpox virus disease - a European multicentre observational cohort study (MOSAIC).

Background: The global mpox outbreak which started in May 2022 was caused by a novel clade IIb variant of the mpox virus (MPXV). It differed from the traditional Western and Central Africa disease in transmission patterns and clinical presentation.

Methods: To address the need for detailed clinical and virologic data, we conducted an observational cohort study (MOSAIC) during May 2022-July 2023 in individuals with confirmed MPXV infection enrolled in six European Countries.

Therapeutics for Nipah virus disease: a systematic review to support prioritisation of drug candidates for clinical trials.

Nipah virus disease is a bat-borne zoonosis with person-to-person transmission, a case-fatality rate of 38-75%, and well recognised potential to cause a pandemic. The first reported outbreak of Nipah virus disease occurred in Malaysia and Singapore in 1998, which has since been followed by multiple outbreaks in Bangladesh and India. To date, no therapeutics or vaccines have been approved to treat Nipah virus disease, and only few such candidates are in development.