COVID-19 Pandemic Sparks Medical Innovation
From the use of anti-inflammatory and antiviral medications to the use of a “smart ring” to monitor body temperature, the crisis resulting from the COVID-19 pandemic has provided the impetus for clinical and technological innovation. Clinical studies are being quickly initiated at health systems and research organizations around the world to explore a variety of potential weapons in the pandemic. On April 10, Clinical Trials.gov listed 440 studies associated with COVID-19. As you have undoubtedly observed, the COVID-19 news is more than any of us can (or want to) consume. We hope to play a role in providing an insight into those that we think will interest you.
Prevention of COVID-19 infection with a mouth spray?
A compelling new trial targeting healthcare professionals on the frontlines was announced in Ohio on April 2. Dr. Robert Salata, an infectious disease specialist and chairman of the department of medicine at University Hospitals Cleveland Medical Center is the principal investigator for the ARMS-1 COVID study. The goals of the trial are to evaluate whether the oral spray-which had been available over the counter since 2012-(1)works to provide protection against COVID-19 for front-line clinicians and whether (2)there is a decrease in the duration/severity of the infection in those clinicians who do contract the virus. The purpose of the oral spray is not to treat those already infected with viral illness, but to prevent airborne transmission of viral infections. The product showed promise in preventing influenza and other respiratory illnesses in laboratory studies and in a small unpublished clinical trial led by Dr. Salata at University Hospitals in 2015.
On March 23, the product under investigation, an over-the counter spray called “Halo”, was actually pulled from the over-the-counter market while its effectiveness against the new coronavirus is being tested. The manufacturer is reportedly submitting a request to the FDA requesting that the product be granted “emergency-use authorization” making it available to health care workers while the clinical trial is in progress, similar to the designation of the 2 antimalarial agents.
The trial design is a randomized placebo-controlled crossover study. During the course of the trial, every participant will get the investigational drug, even those who started with the placebo. According to Dr. Salata, in addition to University Hospitals, additional hospitals in northeast Ohio are expected to participate. Investigators expect to begin the trial in 2 weeks.