Experimental Treatment with Favipiravir for Ebola Virus Disease (the JIKI Trial): A Historically Controlled, Single-Arm Proof-of-Concept Trial in Guinea

As Ebola virus disease (EVD) was at it’s peak, World Health organization brought up a list of drugs that could potentially be researched to treat Ebola. This research was originally set-up as a randomised trial, but due to high mortality rate, it was found to be unethical for many reasons. The main reason this research was made to be randomized was to avoid any implications that could arise from patients not recieveing treatment drug when they need to as it could lead to less people believing in the healthcare system. So, this research was randomized in which 99 patient’s data was represented in this study.

The study was done using Favipiravir, an antiviral that is used to treat severe influenza, to research it’s efficacy on patients with EVD. All of the patients were given either standard therapy treatment or treatment with experimental drug to see it’s efficacy. During this study of being non-randomized, it was seen that the patient’s with Ct count of less than 20 had high mortality rate than patients with Ct count of over 20. The data extracted from these patients was sufficient to consider whether this drug was efficacious for patients to use in the future, as this study was non-randomized and the the mortality of the patient was as predicted.

This study had no real results, but showed some potential of setting up a clinic for EVD patients. Knowing the ethical implications along with the clinical aspects of treating ebola is what this paper was implying. Although there was not any presentable data that could help with treatment of EVD, this paper helps understand some of the important aspects that a researcher will face if Ebola patients were used in a study. Would you use Ebola patients for your study? How can you justify if a person gets the treatment dose or not having randomized trial?

 

Sissoko D, Laouenan C, Folkesson E. (2016).Experimental Treatment with Favipiravir for Ebola Virus Disease (the JIKI Trial): A Historically Controlled, Single-Arm Proof-of-Concept Trial in Guinea. 2016 Mar 1;13(3):e1001967.

Published online first.

 

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