Colorized scanning electron micrograph of a cell (blue) heavily infected with SARS-CoV-2 virus particles (red), isolated from a patient sample. Image captured at the NIAID Integrated Research Facility in Fort Detrick, Maryland.
One of the biggest challenges in addressing a novel disease is the lack of vetted treatments that can be used when people fall ill. After the emergence of SARS-CoV-2, NIAID efforts played a critical role in accelerating the development of new therapeutics and other countermeasures. In January 2020, the first cases of COVID-19 were reported in the United States. One month later, the Adaptive COVID-19 Treatment Trial (ACTT) began. Sponsored by NIAID, this was one of the first clinical trials for an experimental COVID-19 treatment in the United States. The study evaluated the novel antiviral remdesivir in patients hospitalized with COVID-19.
Remdesivir, developed by Gilead Sciences, Inc., is an antiviral medication that targets a range of viruses. It was originally developed as a treatment for hepatitis C and respiratory syncytial virus (RSV), but also showed promise against other viruses. Remdesivir was previously tested in humans with Ebola virus disease and has shown promise in animal models for treating coronaviruses, including Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS). These studies are part of why the drug was able to be advanced into clinical studies for treating COVID-19 so quickly after the outbreak was first discovered.
The first iteration of ACTT was initiated to evaluate remdesivir as a treatment option for COVID-19. Results showed that hospitalized patients with COVID-19 who received remdesivir recovered faster than similar patients who received placebo. The study also suggested that remdesivir treatment may prevent patients from progressing to more severe respiratory disease. Remdesivir appeared to most benefit patients who were receiving supplemental oxygen.
Based on the ACTT study and two other trials sponsored by Gilead, the Food and Drug Administration (FDA) granted Emergency Use Authorization for remdesivir in May 2020, and the drug received full approval on October 22, 2020, under the commercial name Veklury. The drug is specifically approved for use in hospitalized adult and pediatric patients (12 years and older) and is the first drug approved in the United States for COVID-19.