Reprinted, with minor editing, as a public service amid the Covid crisis.
By RUDY CHINCHILLA
April 3, 2020
Updated on April 4, 2020
at 6:22 am
NBC Universal Inc.
The University of Pennsylvania’s medical school is set to perform clinical trials to see whether a drug used to treat arthritis and malaria can also treat Covid-19.
The Perelman School of Medicine is enrolling patients to determine whether 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 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 groups.
The first will compare HCQ against a placebo for infected patients who are quarantined at home to see whether it can reduce the number of days that people need to be quarantined. This sub-study will take two weeks, Amaravadi said.
The second will look at administering a high dose of HCQ against a low dose for patients who are infected and hospitalized. The idea is to determine whether discharge time can be speeded up. No placebo will be used for this sub-study, which will also last two weeks.
The third sub-study, will check on whether the drug helps prevent Covid in health workers who deal with Covid patients. That trial is set for two months and will include a group receiving a placebo.
Both the first and third sub-studies are “double-blind,” meaning neither the patients nor the doctors know who is receiving what drug. But, if patients start getting worse, both sub-studies will allow them to be “unblinded” and treated with HCQ.
The trial will focus only on patients and health care workers at the Hospital of the University of Pennsylvania or at Penn Presbyterian 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 treatment. Amaravadi, though, cautioned that even if the drug is proven to work, it cannot 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.
The Perelman School of Medicine is enrolling patients to determine whether 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 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 groups.
The first will compare HCQ against a placebo for infected patients who are quarantined at home to see whether it can reduce the number of days that people need to be quarantined. This sub-study will take two weeks, Amaravadi said.
The second will look at administering a high dose of HCQ against a low dose for patients who are infected and hospitalized. The idea is to determine whether discharge time can be speeded up. No placebo will be used for this sub-study, which will also last two weeks.
The third sub-study, will check on whether the drug helps prevent Covid in health workers who deal with Covid patients. That trial is set for two months and will include a group receiving a placebo.
Both the first and third sub-studies are “double-blind,” meaning neither the patients nor the doctors know who is receiving what drug. But, if patients start getting worse, both sub-studies will allow them to be “unblinded” and treated with HCQ.
The trial will focus only on patients and health care workers at the Hospital of the University of Pennsylvania or at Penn Presbyterian 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 treatment. Amaravadi, though, cautioned that even if the drug is proven to work, it cannot 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.
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