A preliminary report of the Favipiravir Observational Study

The Favipiravir Observational Study Group (principal investigator: Dr. Yohei Doi, Fujita Health University) released a preliminary report of the Favipiravir Observational Study in Japan on the Japanese Association for Infectious Diseases website.

Favipiraivr (brand name Avigan) is an anti-influenza drug which was developed by FUJIFILM Toyama Chemical Co., Ltd. Favipiravir can be administered to hospitalized patients with COVID-19 on a compassionate use basis on condition that the hospital participates in this observational study, obtains informed consent from the patient and the provider considers its use to be appropriate. There are two parts to this observational study: this observational study which is tasked with timely reporting of overall characteristics of patients who received anti-viral agents such as favipiravir, and a registry (COVID-19 Registry Japan), which is tasked with detailed reporting of COVID-19 patients in general.

This preliminary report contains entries made to the study database by COB May 15, 2020, consisting of 2,158 patients who received favpiravir for COVID-19 and describes their background, clinical course, outcome and adverse events. The study collects focused data using an online survey home and is not intended to generate a comprehensive data set. Data cleaning is performed as needed, such as when a duplicate entry is apparent, but otherwise the data are included as they were entered. Importantly, COVID-19 patients who did not receive anti-viral agents are not included in the study, thus comparison with untreated patients is not possible.

This study is conducted as part of research grant "Study on multicenter open-label randomized clinical trial of favipiravir to evaluate the viral load reduction effect in asymptomatic and mild patients with SARS-CoV2 infection/A multicenter observational study to evaluate the clinical course of moderate and severe patients receiving favipiravir," from the Japan Agency for Medical Research and Development to Fujita Health University.