The University of Pennsylvania’s medical school is set to perform clinical trials to see if a drug used to treat arthritis and malaria can also treat COVID-19.
The Perelman School of Medicine is enrolling patients to study if hydroxychloroquine (HCQ) can treat already infected people or help prevent infection altogether.
Dr. Ravi Amaravadi, an oncologist and the study’s principal investigator, has been studying the drug as a treatment for cancer for more than a decade. He said side effects on cancer patients have not been severe, which could indicate HCQ might be safe for coronavirus treatment.
“We think this is going to be safe. However, we don’t know until we do the proper clinical trial because with COVID-19, the disease itself is a little bit mysterious. We’re still learning about what it can do to the body,” Amaravadi said.
The drug, which is administered as an oral tablet, first gained some national prominence in a tweet by President Trump in mid-March, but the data about it being used to treat COVID-19 is “limited and inconclusive,” according to an article published by the Annals of Internal Medicine.
That limited research –mostly coming from China and France – on HCQ as a COVID-19 treatment is precisely why larger trials are needed, Amaravadi said. He added that further trials could establish whether the drug actually works, what type of patients might be helped and what doses are needed for a given individual.
The trial is set to start next week and will study 400 people in three different substudies.
- The first will compare HCQ against a placebo for infected patients who are quarantined at home to see if it can reduce the number of days that people need to be quarantined. This substudy will take two weeks, Amaravadi said.
- The second will study a high dose of HCQ against a low dose for patients who are infected and hospitalized to determine if it can reduce the amount of time it takes to discharge a patient. No placebo will be used for this substudy, which will also last two weeks.
- The third substudy will last two months and will compare the drug with a placebo for health care workers treating infected patients, the goal being to establish whether or not HCQ can prevent infection.
Both the first and third substudies are “double-blind,” meaning neither the patients nor doctors know if what is being used is the drug or the placebo. However, if patients start getting worse, both substudies will allow them to be “unblinded” and treated with HCQ.
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The trial will focus only on patients and health care workers at the Hospital of the University of Pennsylvania or at Penn Presbytarian Medical Center, which Amaravadi said will allow for closer control and faster results.
Once the results are published, the FDA will need to evaluate the data along with other studies and decide whether to approve hydroxychloroquine as a COVID-19 treatment. Amaravadi, though, cautioned that even if the drug is proven to work, it can’t replace a vaccine.
“With this virus and the way that it’s spreading, I think we have to use all available resources and all available modalities to tackle it. And hydroxychloroquine may be an important treatment and preventative strategy, but I don’t think it will take the place of a vaccine,” he said.
NBC10's Brian McCrone contributed to this article.