By: Dr. Sanae ElShourbagy Ferreira, NCATS Health Specialist and Dr. Michael G. Kurilla, NCATS Director of the Division of Clinical Innovation
Although COVID-19 infections are decreasing and vaccinations among the adult population hover around 50%, COVID-19 is not quite yet in our rear-view mirror due to a combination of uncertainty regarding durability of immunity conferred by either vaccination or natural infection as well as emerging viral variants of concern. The FDA has authorized emergency use of intravenous monoclonal antibodies in the outpatient setting for patients with mild to moderate COVID-19 at high risk for severe disease, as well as several treatments for hospitalized patients with moderate to severe COVID-19, including anti-viral drug remdesivir, anti-inflammatory baricitinib, and corticosteroids.
For those who become infected with COVID-19 but are not sick enough to be hospitalized, reducing the duration and severity of COVID-19 symptoms with drugs already approved by the U.S. Food and Drug Administration (FDA) could fill an important gap, especially if a reduction in symptoms also reduces potential transmission. More than 80% of COVID-19 cases are diagnosed in outpatient care settings. Making repurposed prescription and over-the-counter medications available that people can self-administer at home can potentially deliver evidence-based COVID-19 treatments sooner to patients in need.
NIH and NCATS recently announced the launch of ACTIV-6. As part of The National Institutes of Health Accelerating COVID-19 Therapeutic Interventions and Vaccines public-private partnership, ACTIV-6 is a platform trial using one master protocol that is designed to simultaneously test the safety and effectiveness of four existing and FDA approved drugs in treating mild to moderate COVID-19 at home, with Ivermectin as the first drug to be tested. Enrollment is now open for the ACTIV-6 Clinical Trial Congratulations to the ACTIV-6 team for enrolling their first study participants in this remote clinical trial!
The CTSA Program offers a natural synergy of resources to conduct ACTIV-6. Duke University’s Trial Innovation Center serves as the ACTIV-6 clinical coordinating center, and Vanderbilt University Medical Center’s Institute for Clinical and Translational Research serves as the data coordinating center. Involvement of the Trial Innovation Network, particularly with respect to the Expression of Interest process for clinical sites, and regular consultation with the Recruitment Innovation Center are additional key assets that the CTSA Program has brought to the ACTIV-6 trial. CTSA Program hubs from Duke University and Vanderbilt University Medical Center are partnering with PCORnet, the National Patient-Centered Clinical Research Network, funded by the Patient-Centered Outcomes Research Institute (PCORI), to expedite enrollment from a broad range of communities to ensure diversity. ACTIV-6 will leverage existing national clinical trial networks to speed the delivery of answers about available drugs that could help people manage COVID-19 symptoms at home.
Bringing more treatments to more people more quickly is at the center of much of what the CTSA Program is all about; featured in the ‘Spotlight’ of the July Ansible below, you will find other examples from around the consortium highlighting the CTSAs’ tremendous local, regional, and national response to the COVID-19 pandemic published in a special issue of the Journal of Clinical and Translational Science. With leadership at CTSA hubs across the country adapting the way we do science in a pandemic, the consortium not only learned best practices from one another, but further demonstrated the CTSA Program as a transformational national network in action, working to address the most pressing patient needs in our communities. I hope that you will take a few moments to enjoy this compendium of articles, representing collective learnings from advancing translational science in the past year.
And so with the sunshine and the great bursts of leaves growing on the trees, just as things grow in fast movies, I had that familiar conviction that life was beginning over again with the summer.
– F. Scott Fitzgerald, The Great Gatsby
This Mike’s Blog was featured in July 2021’s Ansible.