University of California, Irvine (UCI) joins other pathbreaking major academic centers serving as clinical investigative sites nationwide to test Gilead’s remdesivir, the novel antiviral drug developed as a treatment for the Ebola and Marburg virus. With UCI’s official entry into a global remdesivir study, Southern California now joins the race to find a treatment.
There are instances where it appears remdesivir can produce positive outcomes but it is not certain as of yet—this first batch of clinical trials must produce the data—the evidence. It is only in the evidence that the experimental treatment’s value will truly come to light.
Confidence at UCI
Dr. Alpesh Amin, chairman of the university’s Department of Medicine reports that he is confidence, noting all will “get on top of this.” UCI is now working with a drug that has considerable anti-viral attributes given it has been tested in humans for Ebola and in animal studies it evidenced promise in treating SARS and MERS, reports ABC 7 News in Southern California. Amin noted that remdesivir is essentially a Virus stalker—seeking out “unique genetic material that’s on the virus and goes in there and attacks the virus and kills it” essentially an “seek and destroy mission,” declared Dr. Amin. UCI joins an elite group of major academic medical centers banded together under the umbrella of the National Institute of Health (NIH) to test this important experimental drug.
The Adaptive Clinical Trial Design
The sponsor, National Institute of Allergy & Infectious Diseases (NIAID), understands the severity of the COVID-19 pandemic and hence has designed an adaptive study that supports maximum flexibility and agility while ensuring the safety of patients. The idea is to be able to use the clinical trial to quickly study, assess, analyze and not only learn but act on but capitalize on those learnings to the benefit of the study and patients. This is especially important as clinical investigators are just learning about COVID-19 and how to manage this novel coronavirus. Hence, that fact is factored into the study design so that as the study generates knowledge the standard of supportive care may be adjusted and modified accordingly to maximize efficaciousness and positive impact.
The study, a Phase II adaptive randomized, double-blind, placebo-controlled initiative to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adult COVID-19 patients. A multi-center study involving up to 50 research sites globally, it will be conducted as a series of 2-arm comparisons between different therapeutic agents and a placebo. Interim monitoring will introduce new arms and support agility as in a crisis situation such as this, it is imperative to stop any arm for futility, efficacy or safety issues.
So for example, if one therapy treatment regimen approved efficacious, this particular treatment then becomes the control arm for comparisons with the new experimental treatment arm. This type of agile study features are designed into the protocol.
The study commenced February 21, 2020 and will conclude formally April 1, 2023.Of course, it is more than likely to end far sooner, based on the study’s adaptive design, actionable data will be incorporated into a changing standard of care.
Other Participating Research Sites
Currently 19 sites are listed as participants, and that number could total up to 50. According to the government’s website Clinicaltrials.gov, the following sites are involved in this critical adaptive clinical trial. Most are not recruiting as of yet hence why UCI made the claim, they are the first in Southern California. University of California, San Diego is also participating in the study but as of yet not recruiting.
University of California, Irvine Infectious Diseases
Part of UCI’s School of Medicine, Division of Infectious Diseases centers on a broad range of infectious diseases from HIV/AIDS, tuberculosis to hospital-acquired infections and infections associated with traumatic injuries to those associated with travelers and immigrants. Their website touts the internationally regarded faculty specializing in basic, clinical and translational research infused into various UCI groups making the division at the forefront in targeted clinical research areas such as the Institute for Immunology and Center for Virus Research as well as the Pacific Southwest Regional Center for Excellence in Biodefense and Emerging Infectious Diseases. The Division Chair is Donald Forthal, Professor of Medicine and Molecular Biology and Biochemistry, Center for Virus Research, School of Medicine, Chief Division of Infectious Diseases.
Center for Virus Research
UCI’s Center for Virus Research was established to foster scholarship, training and collaborative research at UCI across many disciplines, based on studies founded in molecular biology. This center offers both administrative infrastructure as well as training and common laboratory facilities required for virus-based interdisciplinary research. The Center for Virus Research is led by Bert Semler, Distinguished Professor, Microbiology & Molecular Genetics School of Medicine Director, Center for Virus Research.
Lead Research/Investigator (for NIAID)
John Herbert Beigel is the principal investigator/NIAID appointed lead for the entire clinical trial worldwide. Beigel is part of the Associate Director of the Division of Microbiology and Infectious Diseases, Office of the Director as well as Director of Office of Clinical Research Affairs (OCRA).
Call to Action: Interested in connecting with the sponsor of this study—the NIAID? John H. Beigel is the lead, and his contact information is here. Look at least some of Beigel’s body of research here.