The University of Minnesota has been selected by the National Institutes of Health (NIH) to oversee international clinical trials of synthetic antibody therapies in a bid to treat COVID-19. TrialSite News reported the actual investigational product is known as LY-COV555, produced by a partnership between Eli Lilly and a Vancouver startup named AbCellera. Backed by the NIH study program known as ACTIV-3, the sponsor and investigators hope to showcase a powerful way to harness the power of these monoclonal antibodies to inhibit COVID-19. Due to its deep and extensive experience conducting international infectious disease studies, James Neaton’s INSIGHT network was chosen to conduct the inpatient clinical trial. The study is funded, with multiple millions, out of public funds associated with Operation Warp Speed and part of the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program. The INSIGHT network participates with the national COVID-19 Prevention Network (CoVPN).
TrialSite offers a brief breakdown of prominent COVID-19 studies in Minnesota, thanks to recent reporting by Pulitzer Prize winning Jeremy Olson of the Star Tribune.
What is the premise of these monoclonal antibody and remdesivir studies?
As conveyed by James Neaton, the research establishment increasingly suspects that a combination of drugs will be required to beat COVID-19. Hence, the combination of investigational monoclonal antibody and remdesivir. Neaton told journalist Olson, “I think they may compliment each other,” continuing, “These drugs have different methods of action. I liken it to the days in HIV.” He also commented that sponsors experimented with different drugs in combination to fight the infection back then.
What are these antibodies?
The human immune system actually produces them as a response to SARS-CoV-2 exposure including “so-called neutralizing antibodies that fight off the virus” reports Olson. Now the Lilly and Regeneron (another commercial monoclonal antibody cocktail) are actually called monoclonal antibodies which means that researchers actually went through the process of analyzing plasma from COVID-19 patients (and in labs) and actually singled out neutralizing antibodies associated with COVID-19 patients for purposes of reproduction in large amounts to be used in clinical trials. If they actually work, then providers will have a potentially powerful weapon against COVID-19.
Who is funding these ACTIV Studies?
The federal government via Operation Warp Speed grants totaling in the millions of dollars.
Is the INSIGHT Network and the University the only research sites involved?
No, three other large networks are collaborating as well, collectively representing the COVID-19 Prevention Network.
Where else is this trial taking place?
The trial is taking place at select hospitals around the world that are part of existing trial site networks. They include the lead network, the International Network of Strategic Initiatives in Global HIV Trials (INSIGHT), operated by the National Institute of Allergy and Infectious Diseases (NIAID). Collaborating clinical trial networks include the Prevention and Early Treatment of Acute Lung Injury Network (PETAL) and Cardiothoracic Surgical Trials Network (CTSN), supported by the NIH’s National Heart, Lung and Blood Institute through the Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies (CONNECTS) program and the U.S. Department of Veterans Affairs Medical Centers.
Which monoclonal antibody is used in the first trial?
As mentioned, the first trial launched in August by the study group is using a monoclonal antibody developed by Eli Lilly called LY-COV555. Lilly partnered with AbCellera to identify this target.
When will the first study results be available?
By the Fall, according to Dr. Neaton.
What about the HCMC (Hennepin Healthcare)?
According to Olson, the local health system is also participating in this first clinical trial. The study requires that patients be hospitalized with COVID-19 and are also given remdesivir. Olson points to the separate clinical trial testing investigational drugs on an outpatient basis.
Why are large clinical trials, such as the ones associated with the ACTIV program, important?
Professor Neaton suggests that these studies share large pools of patients and different therapies to expedite results.
Why has Minnesota been influential in COVID-19 research?
The University of Minnesota helped conduct a study that produced the evidence that hydroxychloroquine doesn’t prevent or stop onset symptoms of COVID-19, while the Mayo Clinic led the nation’s convalescent plasma therapy program.