Developed 40 years ago as an antidepressant medication, fluvoxamine actually may help patients with COVID-19 recover from the virus based on the results of clinical trials previously reported by TrialSite. Recently led by Washington University School of Medicine in St. Louis, TrialSite interviewed principal investigator Eric Lenze for fascinating insight. With funding from wealthy entrepreneur and philanthropist Steve Kirsch, the “Stop COVID-Trial” evidences positive data points: so much so that Kirsch recently issued a challenge that he would pay $25,000 to the first person that could prove the fluvoxamine needed more data to evidence treatment of COVID-19. Clinical investigators at University of Utah Health now believe the drug works and pursue a bigger study to verify and validate the significant results of the first two earlier clinical trials. This generic, and importantly cheap drug—at $0.60 a pill—represents a repurposed therapeutics’ strategy that a growing number of doctors, researchers and other health care professionals deem mission critical to control the pandemic. Now in addition to Washington University School of Medicine in St. Louis, the University of Utah and a few other prominent centers lead this 100% decentralized clinical trial, where patients can treat and self-monitor in the comfort of home.
The Word Spreads
TrialSite Podcast interviewed Dr. Eric Lenze back in early January and had been following the research since the first study at Washington University School of Medicine in St. Louis. That fluvoxamine, an antidepressant, could prevent COVID-19 infections from worsening, represented an exciting breakthrough. After all, a big challenge across much of the developed world is that the medical centers and providers were not methodically treating patients with mild to moderate onset SARS-CoV-2, but rather would send such patients home to rest and self-quarantine. In sufficient numbers of cases, the condition worsened and the patients are back at the provider and ultimately admitted into the hospital. It’s then that they receive remdesivir and, if the situation merits, other treatments such as emergency monoclonal antibodies or corticosteroids.
What if there was an economical, easy-to-administer treatment that could reduce the progression of the disease? After all, billions are now invested by the U.S. government (that is, the taxpayer) into pharmaceutical companies to develop such treatments, from AstraZeneca to Merck and Brii Biosciences. Those are important, but what if a cheap generic drug available now proved to work?
Gap in Care of COVID-19
TrialSite has covered many researchers, physicians, nurses, and others that call out the enormous gap in care during this pandemic. National health and research agencies have focused primarily on vaccine development, although billions are also invested in pharmaceutical-based therapeutic. But really the key breakthroughs thus far are actually represented by repurposed drugs such as dexamethasone as indicated by the RECOVERY trial for more severe hospitalization cases.
But the vast majority of COVID-19 cases involve mild to moderate onset of the disease, where people in much of the developed world are simply sent home and told to rest and self-quarantine. If the symptoms intensify, they are instructed to come back to the hospital.
Of course, a growing cry for repurposed drugs such as ivermectin (based on about 40 studies), fluvoxamine and colchicine, or favipiravir in some countries, such as Russia or India, grow ever more louder with mounting data of efficacy.
Recently, KSL’s Jed Boal probed this repurposed medication originally considered for COVID-19 from some research at University of Virginia School of Medicine. Dr. Adam Spivak, assistant professor in the Division of Infectious Diseases at the University of Utah, went on the record on the “huge gap in our arsenal” speaking of the dearth of treatments for the individual self -quarantined at home. Dr. Spivak continued, “We’ve spent a lot of time these days thinking about vaccines. We’d love to prevent the disease. But people are still getting COVID, and they still will until we get enough people vaccinated.”
Dr. Spivak continued on KSL: “We need a drug that stops people from getting sick when they get COVID, and that’s what we’re hoping fluvoxamine will do.”
One growing thesis of course centers on the premise that individuals that get sicker from COVID-19 aren’t actually sick from the virus itself but the human response to the virus. This inflammatory reaction sickens people, shares Dr. Spivak, and therapies are needed that can be administered to people easily, economically and efficiently.
The WUSM Study
Back at Washington University School of Medicine in St. Louis, the study there involved 150 people with confirmed COVID-19. In that study reported on by TrialSite, Spivak shared, “Eighty people got the fluvoxamine, and zero of those people got sicker. They all recovered.” Of the patients in the placebo group, 8% were ultimately hospitalized.
A similar result occurred during the California race track real-word trial after the COVID-19 outbreak there. That story was recently covered by 60 Minutes.
The STOP COVID-2 Study
Now principal investigators and clinical research staff from “The U” here in Salt Lake City, Utah, participate in the multi-site “STOP COVID-2” trial. Led again by Washington University School of Medicine in St. Louis, the STOP COVID-2 (NCT4668950) trial started at the end of 2020 and runs until the summer. Led again by Principal Investigator Dr. Lenze—and Dr. Spivak in Salt Lake City’s University of Utah—the goal of this study is to determine if fluvoxamine can be used early in the course of the COVID-19 infection to prevent more serious complications, such as shortness of breath.
Targeting a total of 1,100 participants, the investigators will randomize about 880 participants aged 30 and up who have tested positive for COVID-19. To be eligible, participants must experience mild symptoms.
The participants will be randomized 1:1 to take either fluvoxamine or a placebo. A double-blinded study, this particular stage will take about 15 days. The participants will take up to 100mg of fluvoxamine or placebo by mouth twice daily for a daily total of 200mg. They will continue this regimen for 15 days. The dose may be adjusted depending on tolerability.
The participants will be followed for about 90 days after the end of the randomized phase. Medical records may be consulted as well by the study team.
The study capitalizes on the confluence of technologies and processes that support what are called remote or decentralized, patient-centric studies. For example, with the advent of telehealth technology, ubiquitous cloud computing, plethora of clinical trials apps and delivery options this study is fully remote, meaning there is no face-to-face contact.
The study materials, for example, as well as the study drug itself are shipped to the study participant’s home. The protocol calls for participation from people both in the United States and Canada. The study embraces a combination of videoconferencing, email and phone.
During the study, participants complete short five (5) minute assessments daily to report the result of self-monitoring (including oxygen level, blood pressure and temperature), as well as shortness of breath rating and any adverse events.
Key Trial Site Centers
Although this study is remote or decentralized, that doesn’t preclude the participation of trial sites. In fact, they are just as important as hubs in this mission-critical clinical trial. In addition to Washington University School of Medicine in St. Louis and the University of Utah Health, other participating sites include Northwestern University, Fred Hutch in Seattle and McGill University Health Center in Quebec, Canada.
· Eric Lenze, MD, Washington University School of Medicine in St. Louis
· Angela Reiersen, MD, Washington University School of Medicine in St. Louis
· Adam Spivak, MD, assistant professor in the Division of Infectious Diseases at the University of Utah
· Rachel Bender Ignacio, MD, Fred Hutchinson
· Emily McDonald, MD, MSc, FRCPC, McGill University Health Center
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