By Jaimy Lee
At least three clinical trials for hydroxychloroquine are trying to establish whether the decades-old malaria medication can prevent COVID-19 infections in frontline health-care workers as hospitals across the country scramble to secure enough gowns and masks for their employees.
This includes two clinical trials at the University of Minnesota testing hydroxychloroquine in health care workers reporting pre- and post-exposure to the novel coronavirus. A third trial, funded by a government agency, wants to know if the drug can prevent infections in 15,000 health care workers.
Another planned clinical trial at University Hospitals in Ohio will look at an investigational respiratory therapy developed by Arms Pharmaceutical LLC and whether it can prevent airborne transmission and reduce symptoms in those who test positive for COVID-19.
“Our health care workers risk exposure to the coronavirus every day, and it’s important to find strategies that might help them, beyond providing personal protective equipment,” Dr. Robert Salata, chair of the department of medicine at UH Cleveland Medical Center, said in an April 2 statement.
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There is growing concern that the current strain on the health care system and its workers isn’t sustainable given the high rates of exposure faced by clinicians working in frontline emergency rooms, intensive care units, and newly established COVID-19 units. At the same time, clinicians are being asked to wear one mask per shift or reuse them at some hospitals.
The COVID-19 pandemic has sickened more than 1 million people worldwide, including nearly 250,000 in the U.S. At least 54,000 people have died. In the U.S., several clinicians have died after contracting the virus, including Araceli Buendia Ilagan, a longtime nurse at Jackson Memorial Hospital in Miami; Kious Kelly, an assistant nurse manager at the Mount Sinai Health System in New York City; and Dr. Tomas Pattugala, primary care physician in Queens, New York.
“The lack of workplace and patient safety right now is catastrophic,” Rebecca Givan, an associate professor of labor studies and employment relations at Rutgers University, said in an email. “Hospitals need to be honest with their workers, and do everything in their power to keep workers safe so that they can continue to provide desperately needed patient care without jeopardizing their own health or that of their families.”
The best guesses on the duration of the pandemic in the U.S. vary, with President Donald Trump putting social distancing guidelines in place through April 30, other government officials saying that the virus could surge again in the fall or winter, and research indicating that intermittent social distancing measures could extend through 2022.
“The health care providers can get a shot potentially that will protect them,” Dr. Debbie Birx, the White House coronavirus response coordinator, said at a March briefing. “We’re focused today on what we need today and to get through this current epidemic, and then we’re also getting prepared in case it comes back in the fall or in case it comes back in the fall of 2021, when we’d have a vaccine.”
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Two of the three University of Minnesota’s COVID-19 trials for hydroxychloroquine will include health care workers. The pre-exposure trial is expected to begin enrolling roughly 3,500 participants on Monday, according to Dr. Caleb Skipper, the study’s co-investigator and a National Institutes of Health-National Research Service Award medical fellow.
“Some hospital systems have had to resort to bringing people back as long as their fever is gone,” he said. “How can we study a medication that can help protect people?”
In large part, nurses, doctors and other health care workers rely solely on personal protective equipment, or PPE, to protect them against acquiring diseases at work. However, there are some instances in which clinicians take medications if they believe they have been exposed to a disease. This includes an antibiotic after treating a patient with meningococcus or taking a HIV drug for post-exposure prophylaxis if exposed to the virus.
The Patient-Centered Outcomes Research Institute, a government agency created by the Affordable Care Act, said Wednesday it is putting up $50 million to fund a registry and a randomized, placebo-controlled clinical trial examining if hydroxychloroquine can prevent COVID-19 infections in 15,000 health care workers. The trial will led by the Duke Clinical Research Institute.