PCORI Statement: Role of PCORnet® in Supporting ACTIV-6 Trial of Medications' Use in Treating COVID-19

We are pleased that the extensive clinical research capacities of PCORnet^®, the National Patient-Centered Clinical Research Network, will help accelerate research to determine if certain prescription and over-the-counter medications can effectively treat COVID-19 among non-hospitalized patients as part of ACTIV-6, a new clinical trial platform announced today by the National Institutes of Health (NIH).

Even as vaccines bring the promise of lowering COVID-19 case rates, infection rates continue to mount worldwide and new variants of the SARS-CoV-2 virus pose unique challenges. There remains a critical need to generate clinical evidence about treatments for this disease to mitigate the global public health crisis's severity and impact.

While some drugs approved for other conditions have been studied to treat symptoms of mild to moderate COVID-19 in small trials, ACTIV-6 aims to provide definitive evidence for patients and their clinicians seeking safe, effective ways to manage COVID-19 and avoid progressing to more severe illness needing hospitalization.

ACTIV-6 will leverage PCORnet to rapidly access multiple sites to enroll participants and streamline study start-up timelines.  PCORI funded the development of PCORnet to provide resources and infrastructure necessary to power more efficient and robust clinical research that fills gaps in knowledge and promotes improved healthcare decision making. By safely and securely harnessing rich troves of health data and the trial recruitment capacities of more than 60 sites comprising the network, PCORnet supports both large and rapid studies in critical areas, most recently COVID-19.

In addition to ACTIV-6, PCORnet also facilitates HERO-Together, a study assessing COVID-19 vaccine-related outcomes among healthcare workers. This study uses the PCORI-funded HERO Registry, which enrolls healthcare workers willing to share their COVID-19-related experiences and participate in pandemic-related research.

ACTIV-6 is part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership focused on COVID-19. ACTIV-6 will be executed through NIH’s National Center for Advancing Translational Sciences. The Duke Clinical Research Institute at Duke University will serve as the clinical coordinating center for ACTIV-6 and Vanderbilt University will serve as the data coordinating center.

ACTIV-6 adds a critical new component to our understanding of how best to deploy our resources to most effectively help lessen the severity of COVID-19 among people who have contracted the disease. Rapid, robust research, like that facilitated by PCORnet, provides vital information so that we can practice evidence-based medicine even in times of health crises.

PCORI’s partnership with NIH to support ACTIV-6 is part of PCORI’s broader COVID-19 research efforts. PCORI has approved nearly $30 million in funding for new studies directly addressing questions about how best to manage aspects of the disease and effects of the pandemic, including care access, mental health issues, and disparities in care for underserved populations. In addition, PCORI has supported enhancements to studies in progress so that they could address related aspects of COVID-19. PCORI has also supported horizon scans to identify, monitor, and report on emerging and available COVID-19-related treatments, diagnostics, preventive measures, management strategies, and systems changes with potential for high impact.