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Health experts warn experimental drugs have be found to be effective before they are made widely available. Getty Images
  • The antimalarial drug hydroxychloroquine is being widely promoted as a “cure” for COVID-19, but we still lack good data on its true benefits.
  • Some small clinical trials have shown possible benefits. But others have shown the opposite.
  • Anecdotal reports don’t really show whether the drug works — and just as importantly, whether it is safe.

The antimalarial drug hydroxychloroquine remains one of the most hyped potential treatments for COVID-19, especially on social media.

However, claims about the effectiveness of this “miracle drug” against the novel coronavirus have far outpaced the available clinical data.

Some small clinical trials have shown possible benefits. But others have shown the opposite.

Until we have results from larger, well-designed trials — which are currently underway — hydroxychloroquine and chloroquine should only be used under the close supervision of a physician.

One of the first studies to suggest that hydroxychloroquine, in combination with the antibiotic azithromycin, might work as a treatment for COVID-19 was done in France.

The preliminary results from this study were quickly shared on social media as “proof” of the drug’s effectiveness. Even President Donald Trump tweeted about the study.

The French study, though, had several design flaws, including its small size and how patients were enrolled into the study.

Since the study’s release, the journal in which the paper appeared issued a statement of concern about some aspects of the study’s design.

The New York Times later reported that Trump has a “small personal financial interest” in Sanofi, the French manufacturer that makes Plaquenil, the brand-name version of hydroxychloroquine.

In addition, results from other small trials and paper preprints suggest that hydroxychloroquine is not effective against COVID-19.

Newsweek also reports that hospitals in Sweden have stopped using chloroquine to treat patients with COVID-19 after reports that it causes vision loss and blinding headaches.

Beyond the few small studies of hydroxychloroquine, a lot of the “evidence” for its benefits is based on reports in the news and on social media about patients getting better after being given the drug.

Unfortunately, these anecdotal reports don’t really show whether the drug works, and just as importantly, whether it is safe.

“Most people with coronavirus get better on their own. So if you give hydroxychloroquine to somebody who was going to get better anyway, it looks like the drug works,” said Dr. Allison Bond, an infectious disease physician at the University of California, San Francisco.

Many factors affect whether someone recovers from COVID-19. Older adults and people with underlying medical conditions are at higher risk of serious illness.

People being treated in hospitals overwhelmed with COVID-19 patients may also be less likely to recover due to lack of medical resources.

Anecdotal reports can’t account for these factors.

They also can’t answer other important clinical questions like what medication dose works best, when to give the medication, or whether you should be giving a combination of drugs.

“The only way we can know if an agent actually worked or had efficacy is to do a clinical trial,” said Dr. Steven K. Libutti, director of the Rutgers Cancer Institute of New Jersey and senior vice president of oncology services at RWJBarnabas Health.

Bond says these trials should include not just a larger number of patients, but also a wide variety of patients.

“That way, you can see how the drug interacts not only with the infection itself, but also with the patient’s preexisting medical conditions,” she said.

Clinical trials are also needed to know if a drug is safe.

Doctors already know a lot about the side effects of hydroxychloroquine and chloroquine because the drugs have been around for years.

But Bond says patients with COVID-19 who are being treated may need a higher dose of the drug than what’s used for other conditions.

“Even though it’s a drug that we already use, we’re using it at a different dose,” she said. “With that [higher dose] you would be more prone to side effects.”

Several larger, better designed clinical studies of hydroxychloroquine have already been started, including ones at the National Institutes of Health, the University of Washington, and Rutgers Cancer Institute.

Libutti is one of the researchers running the Rutgers trial.

In this study, people with COVID-19 will be randomly enrolled into one of three groups: hydroxychloroquine alone, hydroxychloroquine and azithromycin, or supportive care for 6 days followed by hydroxychloroquine.

“We’re looking to see if these drugs, alone or in combination, can actually lower the patient’s viral load,” said Libutti.

This study is similar to the French study, but is more rigorously designed.

First, people are randomized into the groups, which minimizes bias. Without randomization, you could get mostly healthier people in one of the drug groups — this would make it seem like the drug worked.

There is also a control group — people receiving only supportive care — which allows researchers to see how these people do compared to those taking one or both drugs.

Researchers will also look separately at people with mild, moderate, or severe COVID-19 symptoms, as well as inpatients and outpatients.

“We’re going to look at those subgroups to get an idea of whether the drug worked better at certain times in the course of the disease versus others,” said Libutti.

The trial is moving ahead quickly. After they have finished enrolling the 160 people, he expects to have results in about 2 weeks.

Although this study may not answer all questions about hydroxychloroquine, the results should provide doctors with more data on how best to help people with COVID-19.

“If the [drug or drug combination] works, we need to deploy the strategy much more broadly,” said Libutti. “If it doesn’t work, then we need to be focusing on other strategies.”

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