Duke Clinical Research Institute recently announced the elite research center is participating in the latest National Institute of Health (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), which focuses on repurposed, generic therapies targeting COVID-19. Formally titled “The Randomized Trial to Evaluate Efficacy of Repurposed Medications,” this nationwide, double-blind study is expected to enroll up to 15,000 participants across America. Therapies include Ivermectin, Fluvoxamine, and Fluticasone. But other medications are under consideration, according to TrialSite sources. Unfortunately, this kind of study comes quite late in the pandemic process, but it’s better now than never.

TrialSite has been reporting on significant investment in repurposed drugs for well over a year now. While dozens of ivermectin studies have been conducted worldwide, developed economies have been slow to embrace low-cost, effective treatments to help care for the vast segment of the COVID-19 patient market: the 90%+ of patients that are at home, either asymptomatic or with mild-to-moderate symptoms. 

At Duke, the ACTIV-6 study is led by Adrian Hernandez, MD, the study’s administrative principal investigator—Dr. Hernandez also serves as executive director of the DCRI. In a recent press release, he went on the record declaring the importance of finding easy-to-administer treatments early on to reduce the risk of COVID-19 hospitalization or death. He said, “Currently, there are no approved prescription medications that can be easily given at home to treat mild-to-moderate symptoms of the virus early in its course to prevent worsening of COVID-19.”

This study leverages PCORnet® infrastructure, called the National Patient-Centered Clinical Research Network, supported by the Patient-Centered Outcomes Research Institute and the Trial Innovation Network. This represents a collaborative initiative within the NCATS Clinical and Translational Science Awards Program that helps address critical roadblocks in clinical trials and accelerate the translation of novel interventions into life-saving therapies.

Delays

TrialSite has been made privy to information of delays in getting this important study off the ground. The study of ivermectin is critical, given the dozens of studies and meta-analyses already completed that demonstrate at least some efficacy and safety. We are not certain the cause of the delays, but given the severity of the ongoing crisis, they are troubling. 

Other Repurposed Studies

Another major ivermectin study in America is the COVID-OUT study. The University of Oxford PRINCIPLE study is also looking into ivermectin in the U.K., but TrialSite sources share a real concern with the PRINCIPLE protocol.

Moving Forward

Although TrialSite has been very critical of the NIH and their proclivity to favor vaccines and expensive novel, high-risk pharmaceutical therapeutics during this pandemic, we praise the NIH for finally getting this study going. Susanna Naggie, MD, is the DCRI principal investigator and oversees the coordinating center for the study. She undoubtedly is trying to contribute enough evidence to help society produce more low-cost options to help fight the pandemic. This media platform commends her and the team at DCRI.

In a recent press release, Dr. Naggie declared, “Speeding enrollment in the ACTIV-6 study is of critical importance as the pandemic evolves and highly transmissible variants appear throughout the nation and around the world.” She continued, “The study will yield valuable data on whether repurposed medications can help address the unmet public health need for people experiencing mild-to-moderate COVID-19 symptoms.”

Big Stakes

TrialSite has emphasized the importance of this market for COVID-19, considering the overwhelming number of cases involve either asymptomatic or mild-to-moderate SARS-CoV-2. For well over a year now, what has been desperately needed are both low-cost generic treatments (e.g., ivermectin, et al.) and pharmaceutical developed therapies that potentially will cost more. There are different markets for antiviral-type products with varying price point realities in this age of COVID-19.

The reality is that much of the world cannot afford expensive medication and generic drugs, whether it be ivermectin or something else that needs to be available. That shouldn’t stop pharmaceutical companies from developing other compelling options. Presently, companies such as Merck, Pfizer, and Roche are working on treatments for this market. But on the other hand, there should be absolutely no consortiums actively interfering with access to studies and positive momentum. 

The goal now has to be to accelerate access to help transition the world out of this pandemic. This will not happen by vaccination alone, and the NIH knows this—hence why recently, Dr. Anthony Fauci went on the record as to the importance of early treatment orally administered options to combat COVID-19. All along, TrialSite has called out for a combination of vaccines, early treatments, and smart public health policy, factoring in data-driven risks of those most vulnerable to the pathogen. 

About DCRI

The DCRI, part of the Duke University School of Medicine, is the largest academic clinical research organization globally. Their mission is to develop, share, and implement the knowledge that improves global health through innovative clinical research. The institute conducts multinational clinical trials, manages major national patient registries, and performs landmark outcomes research. The DCRI is a pioneer in cardiovascular and pediatric clinical research and conducts groundbreaking clinical research across multiple therapeutic areas, including infectious disease, neuroscience, respiratory medicine, and nephrology. The DCRI is also involved with ACTIV studies, serving as the U.S. coordinating center for ACTIV-6, a COVID-19 master protocol study testing immune modulators, and participating in ACTIV-4, which examines optimal oral use anticoagulants to prevent COVID-19-associated blood clots. The DCRI also serves as the coordinating center for major clinical research programs, such as the Environmental Influences On Child Health (ECHO) program, the Antibacterial Resistance Leadership Group (ARLG), the NIH Health Care Systems Research Collaboratory, and the Pediatric Trials Network (PTN).

Lead Research/Investigator for DCRI

Adrian Hernandez, MD, the study’s administrative principal investigator

Susanna Naggie, MD, DCRI principal investigator

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