This article was originally published on May 20, 2020. It was updated on June 15, 2020 to reflect new information about this rapidly evolving situation.
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With the COVID-19 (coronavirus) pandemic stretching on, new conversations revolve around potential cures, vaccines and other preventative possibilities. Chief among those has been the drug hydroxychloroquine which has also generated a lot of headlines in recent weeks.
While hydroxychloroquine is currently the subject of many clinical trials, including one in which Cleveland Clinic is participating, results are inconclusive so far. And the FDA recently revoked emergency authorizations that allowed the drug to be used as a COVID-19 treatment.
But despite making the news and social media feeds, Cleveland Clinic experts recommend against using it. We spoke to cardiologist Steven Nissen, MD, and critical care specialist Abhijit Duggal, MD, about the drawbacks of adopting the drug.
Understanding the uses and side effects
The main uses for hydroxychloroquine currently are to treat rheumatoid arthritis and lupus. With rheumatoid arthritis, a patient’s overactive immune system attacks his or her joints, causing the swelling and pain. Hydroxychloroquine can help regulate that immune system.
Though the drug was at one point a popular anti-malarial treatment, Dr. Nissen notes, “It’s not very common anymore because there are better and safer drugs available.”
While the drug has benefits, there are other risks. Dr. Duggal notes many of these risks are similar to others, including gastrointestinal symptoms and the risk of negative interactions with other prescriptions a patient may be using.
The most feared side effect, though, is a heart rhythm disturbance which, according to Dr. Nissen, is a type of ventricular tachycardia called “torsades de pointes.” During an episode of ventricular tachycardia, the heart is beating so fast that the blood pressure drops so the heart cannot pump enough oxygen to every part of the body.
It’s a chaotic rhythm,” he says, “and it can be very difficult to treat.”
These risks are why arthritis patients are closely monitored when the drug is first administered.
Clinical trials ongoing
Besides the side effects, incomplete trials are another reason many doctors remain skeptical about the drug’s use.
Preliminary in vitro (outside of a living organism) studies showed a potentially positive impact of the drug on the coronavirus. But Dr. Duggal says these studies were problematic because they were retrospective in nature. “We did not have a good control of other factors so that we could say that it was the drug causing the positive effects.”
Dr. Duggal is currently part of a Cleveland Clinic team involved in an ongoing randomized control clinical trial for the drug. In these trials, some participants receive the drug but others receive a placebo and the results are judged against each other to see if the drug is impacting the patients or if there are other elements that may play a role.
But this new trial, which will involve about 600 patients, is still in the enrollment phase. “Right now, we have no information in terms of whether there is a signal in any direction or not,” Dr. Duggal says.
Dr. Nissen is also skeptical because of findings from other trials conducted on the drug and COVID-19, saying, “So far, the results of the clinical trials have not been promising. At least one study reported an increase in mortality with the drug when used to treat COVID-19 patients.”
He adds, “Until there’s research showing benefits, we have to be very careful about the risks.”
Too many unknowns
Both Dr. Duggal and Dr. Nissen recommend that patients do not use the drug as a COVID-19 treatment. There are too many unknowns and while there has been success with the drug in arthritis patients, that application is in lower doses and under the direct supervision of a healthcare professional.
“There is no data on using hydroxychloroquine as a preventative medication, there’s nothing to support that,” says Dr. Duggal.
He adds that the Infectious Disease Society of America, the Society of Critical Care Medicine, and the American Thoracic Society have all advised that the drug shouldn’t be used with COVID-19 patients outside the context of a controlled clinical trial “because we don’t really know the effects in terms or prevention or treatment.”
“I absolutely recommend people avoid it. I can’t say that strongly enough,” Dr. Nissen says. “There’s no evidence for treatment or prevention of COVID-19. The idea of taking it to prevent infection is not a sensible thing to do.
There’s also the interruption of the drug’s availability to treat those aforementioned illnesses for which it’s already used.
“There’s been hoarding of the drug for COVID-19 purposes by people who are managing to get their physicians to prescribe it which means that people who actually need the drug can’t get it,” Dr. Nissen says. “Keep in mind, this drug can have lethal side effects. I would wait for the research and stay away.”