Barely three months ago, the anti-malarial drug that President Donald Trump touted seemed like such a sure bet against COVID-19 that Susanna Naggie had a tough time setting up a national clinical trial comparing it to placebo. Colleagues said giving a fake pill would be unethical since the real thing might save lives.
Now, hydroxychloroquine, or HCQ, has fallen into such disfavor that healthcare workers are leery of Naggie's trial. Called HERO (a loose acronym for HEalth Care Worker pROphylaxis Against COVID-19) it is designed to see if the drug can protect them from infection.
"Our original recruitment goal was 15,000," said Naggie, vice dean for clinical research at Duke University School of Medicine. "We are reevaluating that because, with everything that's happened, it has certainly decreased interest among healthcare workers in participating."
Of all the hundreds of existing drugs being tested against the coronavirus, it is safe to say HCQ and its cousin chloroquine have been the most contentious. HCQ was rushed into clinical use based mostly on desperation and Trump's endorsement of what he called "a game-changer." So much was diverted that people who use the drug for its proven uses feared shortages and escalating prices.
Then rigorous studies showed it didn't help treat or prevent COVID-19. Last month, the U.S. Food and Drug Administration revoked its emergency use authorization, and warned of potentially deadly side effects. Soon after that, the World Health Organization stopped an international treatment trial of HCQ, and the National Institutes of Health pulled the plug on two big studies -- one that appeared to be futile, and another that couldn't recruit enough participants.
Yet researchers are not giving up on HCQ. Far from it. Hundreds of studies around the world -- including dozens in the U.S. and some in Philadelphia -- are continuing, according to clinicaltrials.gov, the U.S. government website that lists trials. (The FDA now says the drug shouldn't be prescribed for treating or preventing the coronavirus except in a trial.)
Why keep investing in a seeming loser? The most common answers: Studies to date have not been definitive. Results need to be confirmed, or "reproduced," by different research groups. And finding even a glimmer of benefit would be valuable against a virus that is so far unstoppable.
But pride, prejudice, and protocols may also be driving hope against hope.
The University of Pennsylvania is continuing two trials -- at least until the independent board that monitors safety analyzes the latest data. One trial is testing HCQ as a treatment for COVID-19 patients quarantined at home. The other study is testing HCQ to prevent infection in health care workers who are at high risk because of their jobs.
"The overall enrollment rate into research studies has decreased primarily because the numbers of COVID cases has decreased" locally, emailed Emma Meagher, chief clinical research officer for Penn's Perelman School of Medicine. "COVID-positive patients and healthcare workers continue to be enrolled in the two trials."