KANSAS CITY, Mo. For 30 days, Kansas City doctor Michael Waxman took a daily dose of hydroxychloroquine.
Or maybe, that he just.
Maybe those pills were nothing more than a placebo.
He will not know until the end of a national clinical trial examining whether hydroxychloroquine – the drug that remains in the headlines – can prevent healthcare workers like him from getting covid-19.
The study, led by Duke Clinical Research Institute, takes place at 40 sites across the country, including the University of Kansas Medical Center.
Waxman, a pulmonary critical care physician who has worked at Research Medical Center since 1985, was the first person to volunteer through KU. That earned him the honor of being the “real guinea pig.” He did it happily, without reservation.
“You get to see (on the) frontline how bad and terrible the disease can be,” Waxman said. “And if there’s anything else you can do besides just try to handle it … can you actually take that other step forward?”
But controversy and public confusion over the drug have made it difficult to recruit more volunteers needed to study the potential prophylactic powers of the drug over this new coronavirus, according to researchers at KU, Duke and other sites involved with the HERO HCQ Trial, launched in April.
Recruitment among health care workers went slowly after media coverage of early studies found that hydroxychloroquine did not benefit covid-19 patients. Apparently, politicians who give the value of their two cents have not helped either.
More drama came recently when a group of people wearing white labcoats appeared before the Supreme Court in Washington, DC, to support hydroxychloroquine as a ‘covid-19’ cure. A video of the group was banned by Twitter, Facebook and YouTube because it violated its misinformation policy.
At this point, hydroxychloroquine has become a four-letter word for some people.
“There have been a few times where I talk to people and they say, ‘Yeah, I’m interested, I want to participate.’ And then they say ‘Wait, wait, wait. Is this a hydroxychloroquine test?’ ‘Said KU clinical research coordinator Maggie Messplay.
KU announced in April that it needed 500 health care workers from the Kansas City area to participate.
As of this week, 94 researchers have signed up there, Messplay said, though that is more than on many other sites in the country.
Nationally, the trial enrolled 1,165 participants, a spokeswoman for the duke said. The goal is to reach 2,000 volunteers by the end of August.
The goal given in April was to get 15,000 health care workers involved.
The HERO study takes its name from the Healthcare Worker Exposure Response & Outuits (HERO) registry, launched earlier this year as a way for health care workers in the United States to share with scientists about their work and home life experience back then. t they confront the pandemic.
The register is still open to “all health care workers, including nurses, therapists, doctors, emergency nurses, food service workers, environmental services workers, interpreters, transporters – anyone who works in a setting where people receive health care,” says the website.
People can register for the register at heroesresearch.org.
The hydroxychloroquine trial was the first that registry members were invited to participate; they may also be invited to participate in covid-19 vaccine studies.
Currently, “studies are under more pressure than ever to recruit quickly,” Duke researchers wrote in a recent update of the hydroxychloroquine study.
“Speeches that play in the media can create confusion, which is bad for public health, and can have unintended consequences, such as influencing recruitment for critical clinical research studies designed to help find answers about what works,” what not. “
Said Messplay: “If we do this research and we realize it’s not working, now we know we need to pursue other prophylaxis, or drugs or just the physical barriers we can put between each other.”
Back in April, “we were going to blow up guns, we were really excited to register as many people as possible,” Messplay said. “Then that infamous Lancet article was published.”
In May, the online medical journal The Lancet published a study that said that hydroxychloroquine was ineffective in treating covid-19, causing heart problems and, worse, increasing the risk of death in patients.
The news came like a bomb. The World Health Organization and others stopped hydroxychloroquine studies.
But there were suspicions about the findings, and The Lancet withdrew the study in early June because data could not be verified by peer review by third parties.
By then, however, damage had been done.
“It just took a lot of wind out of our sails,” Messplay said. “That’s how the recruitment was affected.”
Researchers involved in the HERO study were focal pointing out that their project is aimed at preventing covid-19, not treating it, and that unlike in other studies, these subjects are not sick, patients in the hospital.
“It had a definite negative impact,” said pulmonologist Mario Castro, lead researcher on the KU study and vice president of clinical and translational research at the University of Kansas School of Medicine.
‘Truly, it was the treatment tests that were published that showed that it had no effect. Then many of the audience interpreted that ‘Well, why join a hydroxychloroquine study if it does not help me?’
‘What we need to do is kind of adapt and train (people) that,’ Hey, this is not a treatment test. This is really for people who have not got the infection and it is for people who are exposed to it and this can still be a very effective prophylaxis. “
Hydroxychloroquine, sold under the brand name Plaquenil, became a subject of controversy in March when President Trump tout the drug, which has been used since the 1950s to treat lupus, as a “game changer” treatment for the coronavirus.
That enthusiastic remark – largely based on the findings of a French study later refuted by its authors – led to an onslaught on the drug. Millions of lupus and rheumatoid arthritis patients who relied on it stayed tall and dry while running pharmacies.
Many hospitals that treat patients there during the first months of the pandemic have stopped using it.
In June, the U.S. Food and Drug Administration introduced its authorization for emergency use of hydroxychloroquine, and the relevant drug chloroquine, for the treatment of hospital covid-19 patients, “based on recent results of a large, randomized clinical trial in hospital patients who ‘ t these drugs found showed no benefit in reducing the chance of death or faster recovery. “
Dr. Todd Rice, a pulmonologist and associate professor of medicine at Vanderbilt University in Nashville, Tenn., Another site participant in the HERO trial, said it was ‘fascinating’ about the ups and downs of the medicine. to view.
Back in March, when doctors were desperate to find anything that could help covid-19 patients, “you were a devil if you did not give a patient hydroxychloroquine,” Rice said.
Then came the rapid studies.
Then, “there was a movement of ‘this is bad,'” Rice said.
“Well, you’re the devil when you give it to people,” Rice said. “And I think the pendulum that has swung back and forth a number of times is now in the middle range – it’s probably not hurting people, but it’s probably not helping them either, why should we just like it humans? helps? ‘
Health care workers knew they would be in the covid-19 crosshairs. Data from the HERO register have proved this.
Thirty-three percent of more than 12,000 health care workers who registered as of May were exposed to covid-19 – 90 percent of those exposures came to the workplace, according to Duke.
Of those 90% exposed, 1 in 10 was infected, with Black and Latino health workers twice as likely to make contact with the virus, according to Duke data.
“And unfortunately, we saw so many people all over the world who were some of the first victims, the health care providers, the doctors, the nurses, the respiratory therapists and others,” Waxman said.
“And as much as there was prior knowledge of you having to protect yourself – because infection control is not a new topic – we still knew we were there, and sure enough, in the United States, a number of health care workers have also contracted the disease, and some died.
“Knowing that, is there any possibility you can prevent us from getting it?”
One of the problems with the hydroxychloroquine story, Waxman said, is that “people report in addition to everything they’ve seen, they’ve experienced, and there’s a complete lack of really great research that has been reported.
‘In fact, probably a large amount of what you see is just simple observational data, assuming it is not false, because unfortunately there has been little. But even the other things are very observant and… you really need science to really try to differentiate. ”
“Large, randomized controlled trials” are the only way to determine whether hydroxychloroquine covid-19 can occur in people at risk for exposure to the infection, Duke researchers say.
Castro said that is key to this study.
“That’s one of the things that HERO has disputed is that there is very little prophylaxis information,” about hydroxychloroquine, Castro said. “We hope now … that we can certainly answer this with an adequate sample size.”
As with any clinical trial, safety is an issue. The FDA oversees the study, and a board regularly reviews study data to identify problems and ensure that the FDA is notified when they occur.
Hydroxychloroquine is generally considered a safe and well-tolerated medication, Duke says.
Abnormal heart rhythms, such as those mentioned in previous studies, are not common in people who are not hospitalized, Duke researchers say. However, some studies have found that some covid-19 patients had cardiac arrhythmias when they took it.
Because of this, healthcare professionals who are at high risk for certain heart conditions, or who are taking medications that are known to interact with hydroxychloroquine, cannot participate in the HERO study, Duke says.
“Again, that’s part of the confusion in the audience,” Castro said. ‘They hear about these very sick patients who are being treated by hydroxychloroquine and have their heart problems. But again, these are patients who would never come to HERO because we did not use it for treatment purposes, and they were probably excluded because of the medication. ”
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