July 6, 2020

The National Institutes of Health (NIH) have launched a public-private partnership to identify effective treatments for COVID-19. Led by NIH Director Francis Collins, MD, PhD, the initiative has brought together more than a dozen leading biopharmaceutical companies, NIH institutes, the Health and Human Services Office of the Assistant Secretary for Preparedness and Response, the Centers for Disease Control and Prevention, the United States Food and Drug Administration (FDA), and the European Medicines Agency to collaborate on an international strategy for a research response to the novel coronavirus pandemic.

The partnership, called Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), is developing a framework for prioritizing vaccines and treatments for testing; developing master protocols and establishing trial networks to streamline clinical trials; coordinating regulatory review and input; and leveraging assets among all industry partners to respond as rapidly as possible. ACTIV also is creating strategies for being better prepared in the event of future pandemics.

“We need to bring the full power of the biomedical research enterprise to bear on this crisis,” Collins said. “Now is the time to come together with unassailable objectivity to swiftly advance the development of the most promising vaccine and therapeutic candidates that can help end the COVID-19 global pandemic.”

ACTIV has four focus areas — each one overseen by a committee of senior scientists. The first focus area is to standardize and share pre-clinical evaluation methods in an open forum that allows for comparison and validation. The second is to prioritize and accelerate the clinical evaluation of treatment candidates with near-term potential. The third focus area is to maximize clinical trial capacity and effectiveness by connecting existing networks of clinical trials. The fourth is to advance vaccine development by creating a collaborative framework to share insights into natural immunity and vaccine candidate-induced immune response.

Dr. Lisa LaVange

Dr. Lisa LaVange

Lisa LaVange, PhD, is an alumna of the UNC Gillings School of Global Public Health, where she now serves as a professor and associate chair of the Department of Biostatistics. She is supporting ACTIV as a member of the Therapeutics Clinical Committee and co-chair of a Master Protocols Subcommittee.

Members of the Therapeutics Clinical Committee are working toward the goals of the second focus area — prioritizing and testing potential therapeutic agents for COVID-19 — including both novel agents and agents with prior clinical trial experience that are being repurposed to treat COVID-19. Drug candidates for testing are being chosen from agents with either direct-acting or host-directed antiviral activity, including immunomodulators, severe symptom modulators and neutralizing antibodies. After rigorous scientific review, ACTIV assembled a complete inventory of around 170 therapeutic candidates that have acceptable safety profiles and varying mechanisms of action. At the beginning of May, the group presented this first list of repurposed agents and six agents were selected to move forward with testing. In addition, ACTIV is fast-tracking master protocols to develop and test therapeutic antibodies for treatment of COVID-19 patients, based on recent research published in Science and Nature.

Members of the Master Protocol Subcommittee have been working to develop master protocols — defined as one overarching research protocol designed to answer multiple questions — while identifying multiple trial networks able to quickly initiate the studies worldwide. Separate protocols will target ambulatory and in-patient populations of COVID-19 infected patients, and industry partners have been encouraged to submit potential drugs for testing. All four trials are built on an adaptive platform design that allows therapeutic candidates to enter the study as they become available, and to terminate early either due to positive signs of effect or futility. Standards of care in the studies will evolve over time as new agents demonstrate benefit and are approved for emergency use.

“My involvement in ACTIV is due in part to earlier research I conducted with Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, while I was leading the Office of Biostatistics there.” LaVange says. “Dr. Woodcock and I were both strong advocates of master protocols to effectively and efficiently study multiple therapies in a coordinated and collaborative effort, which is the approach ACTIV is advocating now.”

Contact the UNC Gillings School of Global Public Health communications team at sphcomm@unc.edu.

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