Temple University goes back to 1884, founded by Baptist Minister Russell Cornwell. Over a century later with over 40,000 students, the university prepares the largest body of professional practitioners in the State of Pennsylvania. The Lewis Katz School of Medicine has ranked as one of the ten most-sought-after medical schools in the United States. Temple University is now the latest academic medical center to plan an ivermectin clinical trial in the United States targeting SARS-CoV-2, the virus behind COVID-19. Can Temple prove to all that ivermectin can represent a low cost, available option to inhibit the progression of severe COVID-19 infections?
The Key Goal: Low Cost, Simple & Safe Inhibition of COVID-19
A premise in ivermectin research centers on the fact that most COVID-19 cases are mild to moderate; however, for some, the disease can progress to a far more dangerous and even deadly condition. Temple University reports that currently, 81% of COVID-19 patients are afflicted with mild to moderate disease, while 14% of patients may progress to a more severe state.
As is the case in low-and middle-income countries (LMICs), many physicians and researchers seek low-cost available drugs to inhibit SARS-CoV-2 infection or disease progression. They seek “Simple, safe, and low-cost strategies that may be the best solution to inhibit infection and limit transmission and spread of infection.” This is key, especially where the entire national population doesn’t have health coverage. More novel and expensive solutions may be out of reach for many.
The Study Drug
Ivermectin, synthesized and used as an anthelmintic, has been found to have inhibiting qualities against several RNA viruses including SARS-CoV-2, according to Temple University, by inhibiting importin, a/β-mediated nuclear transport that can possibly stop viral proteins from penetrating the nucleus to change host cell function.
As was reported out of Australia, the Monash University in vitro study evidences a single dose of ivermectin can zap COVID-19 in vitro within 48 hours. Temple refers to one retrospective study of 1,400 patients demonstrating an association of ivermectin use with lower-in-hospital mortality (1.4% vs. 8.5%). Of course, TrialSite has chronicled dozens of case series, observational and even randomized controlled studies that the U.S. press won’t publish but nonetheless have occurred, such as the recent study results from Zagazig University showing that ivermectin is effective in reducing the severity of COVID-19. The recent observational study in Broward County (ICON Study) authored by Dr. Jean-Jacques Rajter continues to receive tens of thousands of visits from TrialSite readers around the world.
With the official trial “Outpatient Use of Ivermectin in COVID-19” this randomized, parallel assignment study will include 200 participants and commences October 1, 2020, and runs till the estimated primary completion date of June 2021; the final estimated study completion date is December 31, 2021.
Those patients that meet the inclusion criteria and, of course, randomized into the ivermectin arm will receive a single dose of 0.15-2mcg/kg dose to a maximum of 12 mg. The Temple University team will be utilizing endpoints associated with clinical improvement as measured by a standardized scale.
Derek Isenberg, MD Associate Professor, Emergency Medicine, Lewis Katz School of Medicine
Nina Gentile, MD, Professor, Emergency Medicine, Research Director, Department of Emergency Medicine
Call to Action: TrialSite links to Clinicaltrials.gov for more details, including investigator contact details.