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.
Similar trials are under way in Australia , where they are testing a tuberculosis vaccine in health care workers; France , where a hospital near Lyon is also testing AbbVie Inc.’s (NYS:ABBV) HIV drug Kaletra; Spain ; and the Netherlands , according to ClinicalTrials.gov.
Hydroxychloroquine isn’t approved by the Food and Drug Administration (FDA) to treat or prevent COVID-19 infections; however, the regulator recently used its emergency powers to allow chloroquine and hydroxychloroquine to be used in clinical trials for COVID-19 and to treat some patients who have been sickened by the virus given the lack of proven therapies available to treat the disease.
As outbreaks have worsened in certain regions, hospitals have been faced with an evolving set of policies around who should come to work. The University of Chicago Medicine hospital system said last week that workers who had been exposed to the virus but haven’t tested positive or exhibited symptoms were being brought back to the job.
Rosemarie Yetman-Arac, an emergency room nurse at Mount Sinai, has been home sick for the better part of two weeks. She’s unsure whether she contracted COVID-19 although she has been caring for COVID-19 patients and had worked closely with Kious Kelly, whom she said was a mentor to her. Yetman-Arac said that hospitals aren’t testing frontline health-care workers like herself for the virus; however, she noted that doing so and then keeping workers who aren’t presenting symptoms home would likely create staffing gaps.
“We as a nation have been struggling with PPE,” she said. “It’s a no-brainer to me that there are tons of hospital workers who are probably asymptomatic because we have pretty strong immune systems in general.”
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Thousands of health care workers around the globe have been sickened by the virus, including at least 3,300 health care workers in China, 20% of the frontline clinicians in Italy, and more than 12,000 health care workers in Spain.
The age of U.S. health care workers also raises specific concerns. About 20% of the registered nurses who work in hospitals are between the ages of 55 and 64 years old, and about 30% of doctors who practice across both acute and non-acute care settings are older than 55, according to a JAMA viewpoint published March 30. With the California New York governors asking that retired health care workers return to practice, those percentages may grow.
“Should these older nurses and physicians become infected and required to stay home, or if they become patients, the ramifications could be significant, not only in terms of the loss of their clinical expertise and presence when it is needed the most, but the loss of leadership, judgment, and maintaining morale,” researchers wrote.
Health care providers in the U.S. are scrambling to find enough PPE, which includes gowns, gloves, respirators and masks, to protect the workers caring for COVID-19 patients. National Nurses United, a union representing about 150,000 registered nurses, on Thursday sent a letter to President Trump asking him to use the Defense Production Act to require more manufacturing of these products. Physicians are also concerned about access to PPE; a recent survey of roughly 2,600 physicians that was conducted by physician-networking site Doximity Inc. found that three-fourths of them don’t believe their hospital or clinic has adequate medical supplies and equipment if the pandemic worsens.
A collaboration between Amgen Inc. (NAS:AMGN) and Adaptive Biotechnologies Corp. (NAS:ADPT) to develop antibodies that fight COVID-19 infections may also have potential to protect health care workers, the companies said this week. Vir Biotechnology Inc.’s (NAS:VIR) COVID-19 antibody development program has a similar focus on preventing infections in health care workers and others at high risk of contracting the virus.
The health care sector has outperformed the broader stock market this year, as the SPDR Health Care Select Sector exchange-traded fund (PSE:XLV) has declined 14.8% year to date while the S&P 500 index (S&P:SPX) has dropped 23.0%.