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According to the Centers for Disease Control and Prevention, there are currently no FDA-approved drugs for treating patients with COVID-19. There are, however, drugs approved to treat other diseases that might help coronavirus patients. Researchers are studying them in hundreds of clinical trials around the globe.
But hospitals are faced with a tough decision right now: when a patient has COVID-19, which unproven drugs fall into the "might help, won't hurt" category?
"It's a very difficult position to be in, because we want to be judicious in how we treat patients with COVID-19," says Daniel Kuritzkes, chief of the division of infectious diseases at Brigham and Women's hospital. "We don't want to be throwing the kitchen sink at folks without any basis."
Gyongyi Szabo, chief academic officer at Beth Israel Deaconess Medical Center, also said it well: "The last thing we want to do is expose patients who have COVID-19 to interventions that could make them worse."
Here are five things to know:
1. The "Malaria Drug" — Hydroxychloroquine
Hydroxychloroquine is related to a nearly-century-old malaria drug called chloroquine, which President Trump recently touted.
Hydroxychloroquine may have some anti-viral effects and is known to reduce inflammation. This is good, because it appears that an over-zealous inflammatory response is what causes so much damage to the lungs of COVID-19 patients. The FDA has approved the drug for treating lupus and rheumatoid arthritis, but — though clinical trials are underway — there's no rigorous, scientific data showing that hydroxychloroquine is effective against the coronavirus.
Despite this, there's been a run on the drug across the country, including in Massachusetts. And some local hospitals — including Massachusetts General Hospital (MGH), Tufts Medical Center, Brigham and Women's and Boston Medical Center — are using it on some patients with COVID-19.
"There was some anecdotal clinical data at places that had already had a fair number of COVID cases. It was a drug we could get access to, and although no drug is completely safe, it's a relatively safe drug," said Tamar Barlam, chief of the infectious disease section at Boston Medical Center. "This is very anecdotal data, but this is what we have, unfortunately, right now."
Barlam said doctors at BMC are reserving the drug for patients hospitalized with COVID-19, whose oxygen levels are starting to dip. The drug can have side effects, like retina damage and irregular heartbeat, as well as dangerous interactions with other medications. And mistakes can be fatal: an Arizona man recently died from taking non-pharmaceutical chloroquine phosphate, a version of the drug used to treat diseases in aquarium fish. So doctors ask that you leave the dosing to them.
"The vast majority of people who get COVID-19 are going to do fine. Self-medicating is a big mistake," said Brigham and Women's Kuritzkes. "If they become sick enough to need hospitalization, then they can be treated in a much more supervised manner."
2. An Arthritis Drug That Might Help: Sarilumab
Sarilumab, also known by its brand name Kevzara, is an antibody that may help suppress the runaway immune response that causes so much damage in patients with COVID-19. The FDA approved Sarilumab for treating rheumatoid arthritis in 2017. Again, there's no proof that the drug works against this coronavirus, but researchers recently launched clinical trials at Beth Israel and Tufts Medical Center to see if it might help patients with COVID-19 (For updates on trials in Boston, check the National Institutes of Health's searchable database of all ongoing clinical trials).
The Tufts study will be open to adult patients who have "documented SARS-CoV-2 infection, pneumonia and need for additional oxygen," said Andreas Klein, associate chief of Hematology and Oncology at Tufts Medical Center and director of the Sarilumab trial. SARS-CoV-2 is the scientific name for the novel coronavirus.
Some patients in the study will receive a placebo, or dummy pill, which allows researchers to measure whether the experimental drug is more effective than no treatment at all. "It is critical to include a placebo at this time because we don’t really know that this strategy is helping and it could be making people worse," said Klein. "The study is very carefully monitored for both safety and effectiveness."
3. An Anti-Viral Drug Made For Ebola: Remdesivir
Scientists at Gilead Sciences, Inc. developed Remdesivir during the 2014-2016 Ebola outbreak, but other drugs outperformed it. However, animal studies showed that the drug could be effective against other coronavirus infections, like SARS and MERS.
Remdesivir interferes with how the viruses replicate inside cells, so it may be able to slow or stop the spread of SARS-CoV-2 in the body. The key word here is "maybe," because there is no scientific proof that the drug works against this coronavirus.
Researchers are testing the drug in clinical trials all over the world, including trials at Beth Israel, Brigham and Women’s and MGH. Scientists probably won't have final results for a couple months at least, but the study's "monitoring board" looks at data as it comes in. If Remdesivir appears to be really effective – or really dangerous – the monitoring board can stop the trials.
Gilead was also providing “compassionate use” doses of Remdesivir for patients very sick with COVID-19. But demand got so high that the company sharply curtailed that program in mid-March. There is still some Remdesivir available for compassionate use, but now the primary way to get it is through a clinical trial.
One important thing to remember: Remdesivir is an antivirial medication – if it works, it slows down or stops the spread of the virus in the body. That may turn out to be less helpful for patients who are already very sick, because the virus has already spread and triggered runaway inflammation.
Update: On April 9, Fujifilm announced that three Massachusetts hospitals would soon launch the first U.S. clinical trials of its antiviral drug, Avigan (favipiravir), to see if it works in treating COVID-19. Avigan works in a similar way to Remdesivir, slowing or stopping viral replication.
4. New Drugs On The (Distant) Horizon
There are companies all over the world rushing to find new treatments for COVID-19, including Massachusetts biotech firms like Biogen. But new drugs will have to go through safety testing, and that means it will take months or years before they get to patients.
Doctors at local hospitals don't have that kind of time. That's why they're looking through the antivirial and anti-inflammatory drugs that they already have to see what might work. There’s also been some talk about using antibodies from the blood of patients who have recovered from COVID-19 — the so-called "convalescent serum" — but that research is in its early stages, and none of the Boston hospitals contacted are currently trying this.
5. Other Treatments You May Have Heard About
Some physicians are considering the use of the cholesterol-lowering drugs called statins, since they also have an anti-inflammatory effect. Again, there's no proof that they work for COVID-19, and statins can have serious side effects and drug interactions.
Update: Researchers at MGH have four trials either planned or underway to see if inhaling a gas called nitric oxide can treat or prevent COVID-19.
You may also have heard about Azithromycin, an antibiotic that may help reduce inflammation. In one small study, patients who were given the antibiotic in combination with hydroxychloroquine had less detectable virus in their upper respiratory tract. However, the side effects of the two drugs together -- dangerous irregular heartbeats -- are so severe that doctors are reluctant to use them.
"It's pretty controversial," said Debra Poutsiaka, an infectious disease physician at Tufts. "The data is very thin, and there are real safety concerns."
Some other stuff that doesn't work: the anti-HIV drugs lopinavir and ritonavir. Doctors in China tested them in a recent clinical trial on COVID-19 patients with pneumonia and found no benefit.
Corticosteroids: also not so helpful. While they can help reduce inflammation, they "inactivate large swaths of the immune response, ultimately compromising the entire fight," said Tufts' Andreas Klein.
The best medicine, said Poutsiaka, may be "NPI," or non-pharmacological interventions.
"The best way to beat this virus is what everybody’s talking about — social distancing, wash your hands, don’t touch your face, don’t go to work or be around people who are ill, and if you see somebody who’s sick, stay away from them," she said.
This article was originally published on March 31, 2020.
This segment aired on March 31, 2020.
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