The COVID-19 pandemic has taken a startling toll on frontline health care workers. According to the Centers for Disease Control and Prevention, by mid-April, more than 9,000 had been infected. Undoubtedly, that number is much higher now.
In response, physician-scientists at the University of Miami Miller School of Medicine have begun a clinical study to test whether hydroxychloroquine can prevent COVID-19 among frontline providers.
The trial is part of a multi-site effort to protect health care workers, led by the National Institute of Allergy and Infectious Diseases (NIAID), the agency run by Dr. Anthony Fauci, and the Patient-Centered Outcomes Research Institute (PCORI). Dushyantha Jayaweera, M.D., professor of medicine, and Olveen Carrasquillo, M.D., M.P.H., professor of public health sciences and chief of the Division of General Internal Medicine, are co-principal investigators in the Miller School of Medicine arm of the trial.
Based at Duke University, the two-pronged Healthcare Worker Exposure Response and Outcomes (HERO) study is establishing a nationwide health care worker registry and recruiting thousands to test hydroxychloroquine and, in the future, COVID-19 vaccine trials.
“We know that health care workers have a much higher rate of infection,” Dr. Carrasquillo said, “We really need to know which medications are effective at protecting them when they take care of COVID patients.”
Looking for a Preventive Measure
Hydroxychloroquine has generated much controversy, with some saying it’s effective against COVID-19 and others disagreeing. However, no one has done a large enough study to thoroughly understand its efficacy against the virus. In addition, previous studies have only tested the drug in the sickest patients. The drug’s effectiveness could be more clear-cut if given early to prevent the disease.
HERO seeks to answer that question. The study will use the registry to enlist thousands of frontline medical workers for a placebo-controlled hydroxychloroquine study.
“The study will recruit 15,000 people, around 400 of whom will come from the Miller School of Medicine,” Dr. Jayaweera said. “It's a short study: a one-month randomized placebo control trial, and it will tell us whether hydroxychloroquine works to prevent COVID-19 or not. This is not a treatment trial but a prevention trial, which is critical to understand.”
Though there are a few potential side effects, hydroxychloroquine is well known for its efficacy against malaria, which has been documented since the 1600s.
“In 2017, there were around five million prescriptions for hydroxychloroquine,” Dr. Jayaweera said. “This drug is well-studied in malaria and has a decent safety profile.”
In addition to identifying participants for the hydroxychloroquine study, the registry could help take the pulse of health care workers nationwide and show public health officials how providers are handling the crisis.
“The registry is important because it's a way to follow health care workers longitudinally,” Dr. Carrasquillo said. “We can learn how these risk factors for being exposed to COVID vary in different parts of the country. How well are we using PPEs, and do people have the appropriate access to protective gear? There are also questions about stress and fatigue that will help us better understand how COVID is impacting our frontline people.”
The registry is being well-received by University of Miami providers and has already received significant signups. Investigators hope to begin recruiting for the hydroxychloroquine study this week.
Beyond that, the registry could be a tremendous resource throughout the COVID-19 pandemic, and possibly afterwards, providing a wealth of information about medical workers, as well as possible participants in future studies, including COVID-19 vaccine studies.
“There is a committee being set up to identify additional research,” Dr. Carrasquillo said. “It looks like COVID is going to be with us for a while, and there are other studies that are going to be planned that could be built around this platform.”