The study, which will add to DCRI’s growing portfolio of COVID-19 research, will establish a platform that will generate evidence about whether drugs that are approved for other indications could also be helpful in treating patients with mild or moderate COVID-19 who do not require hospitalization.
The DCRI will serve as the coordinating center for a new COVID-19 study announced today by the National Institutes of Health (NIH) as part of its Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program.
The ACTIV-6 study, which will be executed through the NIH’s National Center for Advancing Translational Sciences (NCATS), will test a number of existing drugs that are already approved by the U.S. Food and Drug Administration (FDA) for other indications to determine if any are also useful in treating symptoms of mild to moderate COVID-19 in non-hospitalized patients and whether the treatments impact need for hospitalization or death related to COVID-19.
The DCRI will partner with the Vanderbilt University Medical Center, which will serve as the study’s data coordinating center. The study will also leverage the infrastructure of PCORnet®, the National Patient-Centered Clinical Research Network, which is supported by the Patient-Centered Outcomes Research Institute (PCORI), to quickly access enrolling sites and streamline study start-up timelines.
ACTIV-6 is a platform trial, meaning that it will study multiple drugs concurrently, and will be conducted remotely, both key characteristics that will enable more pragmatic and efficient research.
“Even with the impressive progress that has been made on vaccines, the pandemic continues to evolve, with new variants and surges of infections in different regions of the world,” said DCRI infectious disease expert Susanna Naggie, MD, the principal investigator who will oversee the coordinating center. “Therefore, there remains a critical need for ongoing clinical evidence generation about treatments for COVID-19 in order to meet public health needs, particularly treatments that can be easily administered by patients in their own home.” Naggie also serves as vice dean for clinical research for the Duke University School of Medicine, of which the DCRI is part.
“With the help of our partners, we will establish an ongoing evidence-generating clinical trial platform to help with treatment of COVID-19 in the outpatient setting—a critical need as the vast majority of people are diagnosed as outpatients who need to know what to do feel better faster and prevent worsening of their illness,” said Adrian Hernandez, MD, MHS, executive director of the DCRI and administrative principal investigator for the ACTIV-6 trial. “We look forward to adding this important project to our portfolio of impactful COVID-19 research.”
The DCRI also serves as the U.S. coordinating center for ACTIV-1, another clinical trial within the NIH’s ACTIV program.