Gilead Initiates Open-Label, Single-Arm Phase 2/3 Clinical Trial of Remdesivir in Pediatric Patients with Moderate to Severe COVID-19

On June 17, 2020 (U.S. time), Dr. Merdad Parsey, Global Chief Medical Officer of Gilead Sciences, issued the following statement on behalf of the company:

"From the outset of the pandemic, in order to explore treatments for novel coronavirus pneumonia (COVID-19), Gilead Sciences began advancing the development of our investigational antiviral drug remdesivir."

Meanwhile, our understanding of the disease continues to deepen. The impact of this novel coronavirus is uneven among adults, particularly affecting older adults and those with underlying health conditions. Furthermore, there have been reports of children and young adults being hospitalized for COVID-19 and developing related autoimmune symptoms. Since February of this year, Gilead has been providing remdesivir to pediatric patients with severe COVID-19 through compassionate use programs and, as of last month, under the Emergency Use Authorization (EUA) granted in the United States. We are now taking further steps to collect data on the use of this drug in the important pediatric population.

In close collaboration with the U.S. Food and Drug Administration (FDA), Gilead Sciences has designed and is poised to initiate enrollment in an open-label, single-arm Phase 2/3 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and efficacy of remdesivir. The trial will treat approximately 50 pediatric patients with moderate to severe coronavirus disease 2019 (COVID-19), ranging from neonates to adolescents. This pivotal study will be conducted at more than 30 sites across the United States and Europe.

“With the goal of improving treatment outcomes for patients infected with the disease worldwide, this pediatric trial further demonstrates Gilead’s commitment to ongoing research on remdesivir to help address emerging patient needs.”

About Remdesivir

Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity, which has demonstrated efficacy against multiple emerging viral pathogens in in vitro and in vivo animal model studies. Multiple ongoing Phase 3 clinical trials are evaluating the safety and efficacy of remdesivir for the treatment of coronavirus disease 2019 (COVID-19). The approval status of remdesivir varies across countries. In countries where local health authorities have not approved remdesivir, it remains an investigational drug, and its safety and efficacy have not been established. In the United States, the U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) for remdesivir to treat hospitalized patients with severe COVID-19. Severe disease is defined as patients having an oxygen saturation (SpO2) ≤94% on room air, or requiring oxygen support, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). This authorization is temporary and does not replace the formal new drug application submission, review, and approval process.

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