About the study

This clinical trial evaluated the efficacy and safety of favipiravir (Avigan) in adults hospitalised with COVID-19 and at risk of developing respiratory failure.

During the COVID-19 pandemic, effective antiviral treatment options were limited, creating an urgent need for well-designed clinical trials assessing potential therapeutic approaches.

The study compared favipiravir plus standard care with standard care alone, as defined by the current recommendations of the Polish Agency for Health Technology Assessment and Tariff System (AOTMiT).

Why favipiravir?

Favipiravir is an antiviral medicine originally developed for the treatment of influenza.

During the early stages of the COVID-19 pandemic, it was considered a promising candidate for limiting viral replication and improving clinical outcomes in infected patients.

However, robust clinical evidence was needed to determine whether the treatment was both effective and safe in patients with COVID-19.

Study design

The project was conducted as a randomised, controlled, open-label clinical trial.

Participants were assigned either to receive favipiravir in addition to standard care or to receive standard care alone.

The study evaluated both treatment efficacy and safety in hospitalised patients with COVID-19.

Study objectives

The primary objective was to evaluate the efficacy of favipiravir in the treatment of COVID-19 among adults hospitalised due to SARS-CoV-2 infection and threatened respiratory failure.

The study also aimed to assess the safety profile of favipiravir and compare outcomes with those achieved under standard care.

Expected outcomes

The project sought to provide evidence regarding the efficacy and safety of favipiravir (Avigan) in the treatment of COVID-19 compared with standard care.

The results were expected to support evidence-based treatment decisions during the pandemic and contribute to the development of future therapeutic recommendations.

Study population

The study planned to enrol 164 patients aged 18–74 years with confirmed SARS-CoV-2 infection based on a positive result from nasal, nasopharyngeal or throat swab testing.

All participants were required to meet the eligibility criteria defined in the study protocol.

Research team

The national coordinating investigator and principal investigator was Tomasz Smiatacz, MD, PhD from the Department of Infectious Diseases at the Medical University of Gdańsk.

Organisational information

The project was funded by the Polish state budget through the Medical Research Agency (MRA) under the Fast Track COVID-19 funding call 2020/ABM/COVID19.

Project number: 2020/ABM/COVID19/0060.

Project duration: 01 November 2020 – 31 March 2022.

Funding and total project value: PLN 3,411,774.59.