Since the end of the pandemic, the social impact of COVID-19 has diminished. We are generally less fearful and perform fewer tests. Nevertheless, the virus remains among us, with new variants, so the virus still poses a threat to people with fragile health. They are at risk of hospitalization or death. Ecraid and UMC Utrecht are investigating whether a drug candidate can protect individuals with fragile health from hospitalization or death due to mild to moderate COVID-19 infection. The study focuses on assessing efficacy and safety.

Because of several shortcomings in currently available antiviral agents against COVID-19 (such as possible interactions with other drugs), there is an urgent need for new and improved treatments that can reduce the risk of hospitalization or death for people with fragile health. The regulatory authority and ethics committee in the Netherlands approved the conduct of this phase 3 study after reviewing data from previous clinical trials of the experimental investigational antiviral drug. It is taken in tablet form.

The study

The study will be conducted at about 330 study sites, including in the United States, Europe and Japan. UMC Utrecht is the participating hospital in the Netherlands. The study focuses on assessing safety and efficacy, with an emphasis on whether the study drug reduces hospitalizations and deaths.

Study leader Prof. Marc Bonten (CEO Ecraid and physician microbiologist at UMC Utrecht) explains: "COVID-19 no longer has the social impact it had a few years ago. However, that does not mean it no longer poses a risk to people with impaired health; quite the contrary! New drugs are still needed to prevent suffering and higher healthcare costs."

Based on data from previous studies, regulatory authorities in the Netherlands have granted UMC Utrecht permission to participate in the conduct of this large-scale, global study.

For whom is the study drug intended?

Individuals at high risk for a severe course of COVID-19, such as those aged 70 years and older (regardless of other risk factors), or those younger than 70 years with risk factors, all regardless of vaccination status for COVID-19. Visit the website for a complete overview and more information: www.vaccinatiestudie.nl.