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By Anne Blythe
As is the case with many physicians across North Carolina, Adrian Hernandez, vice dean for clinical research at Duke University’s medical school, is watching what’s happening globally during this COVID-19 pandemic and wondering how seismic the flood of cases will be here.
“Sadly because we’ve seen our colleagues in Italy and New York and what they’re going through, it’s motivated everybody to be prepared,”
Hernandez said late last week. “We haven’t seen a big pick up yet but it’s starting a little bit.”
Hernandez, a cardiologist, finds himself in the same preparation stage that health care workers and scientists across the country experienced in waves. They try to predict when the hospitals in each state will see a flood of patients infected with COVID-19, how widespread that deluge will be, and what regions will be hit hardest.
“Like anything when you see a storm or hurricane out in the distance, you’re waiting and wondering what path it’s going to take,” Hernandez said.
Amid that wait, the cardiologist and other members of the Duke Clinical Research Institute are gearing up to lead a nationwide study using hydroxychloroquine, or HCQ, the drug that has caused quite a stir amid this pandemic.
The science matters
Just this week, President Donald Trump touted HCQ as the wonder drug, the panacea for the deep lung infection and pneumonia that accompanies the more serious cases.
Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases and an unwavering advocate for data and evidence on the Trump administration coronavirus response team, is more measured. He consistently reminds the country that most of the talk surrounding the propitiousness of HCQ and claims that it is a “knockout drug” is just that — talk.
“We still need to do the kinds of studies that definitively prove that with any intervention, not just this one, is truly safe and effective,” Fauci told a Fox News panel on April 3.
There have been small studies conducted in France and China on the use of HCQ, which has been used for years to treat malaria, rheumatoid arthritis and lupus, on COVID-19 infections.
The French study has drawn much scrutiny and last week, the society that publishes the journal added a cautionary note, saying the article did not meet the “expected standard.”
A small study done in China also has drawn scrutiny, with scientists noting that published details drew from a much smaller sampling than originally planned.
Can it prevent COVID-19?
The Duke Clinical Research Institute will be studying something different. It will look at whether HCQ can prevent COVID-19 infections in health care workers at great risk of contracting the virus while treating others.
“Health care workers on the frontlines are critical in this pandemic,” said Hernandez, the initiator of the study. “Most clinical trials take years to do and finish. We don’t have that time. If we’re able to engage health care workers to fight together and learn together in a massive way, we’re able to get results sooner.”
The federally funded Patient-Centered Outcomes Research Institute has agreed to provide $50 million for what Duke is calling a “rapid-response study” set to begin this month.
Now that the pandemic is here and it could be many months, more likely early next year, before a vaccine is available, scientific hunts for answers have been kicked into high gear.
Calling health care workers
The Healthcare Worker Exposure Response and Outcomes program, or HERO for short, will search for high-risk workers from the National Patient-Centered Clinical Research Network, some 850,000 clinicians and hundreds of health care systems from across the country.
Through that registry, the program will recruit health care and emergency workers interested in taking part in the clinical trial, as well as regularly poll workers on stress levels, burnout and other issues that arise during pandemics.
“The HERO registry of health care workers will ease study start-up times for future clinical trials that may be carried out for other prevention or treatment strategies,” said Susanna Naggie, the associate dean for Clinical Research Initiatives and Regulatory Affairs at Duke who will lead the randomized clinical trial.
Through the HERO study, some 15,000 health care workers chosen from the registry will receive either HCQ pills or placebos for a month and then be followed for two months.
The study aims to find out whether the much-talked-about HCQ is an effective preventative for frontline workers exposed to the virus. It also could determine whether the drug can help prevent workers who might have contracted the virus but remain asymptomatic from further spreading the disease in their communities.
“The HERO study offers an important opportunity for healthcare systems across the country to unite and use the national resources offered by PCORnet to answer some of the most critical questions facing our nation right now,” Judith Currier, a co-chair of the study’s steering committee and chief of infectious diseases at UCLA Medical Center, Santa Monica, said in a statement.
Some people given HCQ might not be able to continue through the study, Hernandez said, if they experience some of the unpleasant side effects. Some users report severe nausea, cramps, headaches and peripheral vision loss, according to reports out of Sweden, where some hospitals have stopped using the drug off-label to treat COVID-19 infection because of those downsides.
As the researchers at Duke and elsewhere prepare for the study launch, Hernandez said frontline workers at Duke Health also are developing strategies to keep their families safe during these unprecedented times so they can treat the patients they know are coming.
“This is why we do medicine,” Hernandez said. “To help others.”