A new COVID-19 study supported by the National Institutes of Health (NIH) as part of its Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program will use PCORnet®, the National Patient-Centered Clinical Research Network, to quickly access enrolling sites, streamline study start-up timelines, and engage the community perspective. The ACTIV-6 study will work collaboratively with participants to develop a platform that will generate evidence about a pressing question in the pandemic: Can medications that are approved for other indications also be helpful in treating patients with mild or moderate COVID-19?
There is currently no approved medication that can be self-administered to ease symptoms of people suffering from mild disease at home and reduce the chance of their needing hospitalization. At the end of the study, the ACTIV-6 team hopes its ongoing evidence-generating clinical trial platform will shed light on the utility of up to seven medications that are already approved for other indications in alleviating the symptoms and clinical outcomes of people with COVID-19.
Putting the needs of everyday people front and center
“There is a lot of research devoted to treatment of severe COVID-19, but it is important to remember most people with COVID-19 are recovering from home, and they are looking for answers on how to feel better,” said Kris Anderberg, the project lead for the ACTIV-6 stakeholder committee. “We formed our ACTIV-6 stakeholder committee to ensure we are appropriately listening to the voices of everyday patients and focusing our research in a way that will make results meaningful to the broader community.”
Impressive progress has been made by vaccines to help curb the pandemic, but new variants and surges of infections in different regions are reminders that COVID-19 remains an evolving threat. To speed insights, ACTIV-6 will be conducted as a platform trial, meaning that it will study multiple medications concurrently, and will be conducted remotely, both key characteristics that will enable more pragmatic and efficient research. In addition, medications will be administered orally or by inhaler and will be easy for participants to take at home. Participants will be assigned randomly to receive either a placebo or one of the treatments, which will be sent to them by mail.
“The medications under consideration already have been tested in humans, so they provide an opportunity to deliver meaningful insights sooner on COVID-19 home treatment options,” said Anderberg. “We are excited about developing this platform as a meaningful tool to inform treatment of those affected by the pandemic.”