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NCT03889106

Cardiovascular Function and Ribavirin Pharmacokinetics and Pharmacodynamics in Patients With Lassa Fever

Terminated Last updated 6 July 2022
What this trial tests

trial testing Ribavirin in Lassa Fever in 2 participants. Terminated before completion.

Timeline
1 March 2019
Primary endpoint
1 October 2020
1 October 2020

Quick facts

Lead sponsorUniversity of Oxford
StatusTerminated
Study typeOBSERVATIONAL
Enrollment2
Start date1 March 2019
Primary completion1 October 2020
Estimated completion1 October 2020
Sites1 location across Sierra Leone

Drugs / interventions tested

Conditions studied

Sponsor

University of Oxford

Who can join

10 and older, any sex, with Lassa Fever. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Lassa fever carries a treated mortality in hospitalized patients of up to 50%. Lassa fever is often described as being characterized by vascular leak and shock in the terminal phase, but, whilst animal data supports this, there are limited data in humans. Therefore, an aim of this study therefore is to characterize cardiovascular function in patients with Lassa fever, with the ultimate goal of informing future trials of supportive or therapeutic strategies. Ribavirin is the current standard of care. However, the efficacy of ribavirin has not been established in a randomised controlled trial (RCT). There is very limited pharmacokinetic (PK) data on ribavirin in patients with Lassa fever and the optimal dose of ribavirin for an RCT is unknown. Furthermore, there are various hypothesized mechanisms of action of ribavirin, none of which have been investigated in humans with Lassa fever. Further aims of this study therefore are to characterize the PK of ribavirin in Lassa fever, and identify any associations between ribavirin PK parameters, viral load and markers of immune/inflammatory status.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Treatment of highly virulent mammarenavirus infections-status quo and future directions.
    Nuñez IA, Crane A, Crozier I, Worwa G, et al · · 2024 · cited 2× · PMID 38606475 · DOI 10.1080/17460441.2024.2340494

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