US clinical trials of hydroxychloroquine hit ‘warp speed’

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A bottle of Prasco Laboratories Hydroxychloroquine Sulphate is arranged for a photograph in the Queens borough of New York, U.S., on Tuesday, April 7, 2020.

Christopher Occhicone | Bloomberg | Getty Images

Researchers are working as quickly as science will allow to determine whether hydroxychloroquine, a decades-old malaria drug touted by President Donald Trump as a potential “game changer” in curtailing the Covid-19 pandemic, is effective in fighting the coronavirus.

Federal health regulators have fast-tracked approvals for coronavirus research, allowing scientists across the nation to skip through months of red tape on potential treatments and vaccines for the deadly virus. On March 24, researchers at NYU Langone launched one of the nation’s largest hydroxychloroquine studies and enrolled their first patient 10 days later. It’s one of more than a dozen formal studies in the U.S. looking at the treatment for CV-19, according to ClinicalTrials.gov.

The drug is proven to work in treating Lupus and rheumatoid arthritis, but not Covid-19. A handful of small studies on its use in coronavirus patients published in France and China has raised hope that the drug might help fight the virus.

New York studies

The study at NYU Langone is one of two being run by New York state. It’s a randomized controlled trial designed to determine whether hydroxychloroquine is any better than a placebo in preventing Covid-19. Co-led with the University of Washington, the clinical study aims to test 2,000 adults who have been in close contact with confirmed coronavirus patients, but haven’t exhibited any symptoms, to see if the drug can lessen the chances of getting the infection.

EMS workers wheel a patient out of NYU Langone Health hospital during the coronavirus pandemic on April 13, 2020 in New York City.

Noam Galai | Getty Images

“We’re trying to move at warp speed,” Dr. Anna Bershteyn, an assistant professor at NYU Langone and the study’s co-principal investigator, said in an interview with CNBC. “The fastest an answer can possibly come we think is in two months.”

The New York State Department of Health, in partnership with the University of Albany, is conducting a so-called observational study that researchers hope can shed some insight into the drug’s potential effectiveness in a matter of weeks, possibly before May. Observational studies aren’t considered as conclusive as randomized controlled trials because doctors can prescribe a variety of other drugs to treat an infection. The less formal process, however, can yield faster results and help with the approval process of some treatments.

Albany researchers

New York officials are providing dozens of hospitals across the state with doses of the drug that physicians can use as part of a patient’s treatment. In return, the hospitals will provide the medical records to the state, which will then be analyzed by Albany researchers.

“The advantage of this study is it has great timeliness,” said David Holtgrave, dean at the University of Albany’s School of Public Health and a researcher working with the state. He said researchers will be able to track how physicians are prescribing the drug and monitor whether it shortens hospital stays, helps patients avoid intensive care or ventilators and improves fatality rates.

Time is of the essence. The virus, which emerged over three months ago in Wuhan, China, has already infected more than 600,000 people in the United States as of Wednesday, overwhelming U.S. hospitals and stretching some past their maximum capacity. In New York, the epicenter of the U.S. outbreak, Gov. Andrew Cuomo announced last week the highest daily death count yet and said life for New Yorkers will never be the same. 

Safety testing

Scientists, including the National Institute of Allergy and Infectious Diseases director Dr. Anthony Fauci, warn that Americans shouldn’t assume hydroxychloroquine is a “knockout” drug just yet. “We still need to do the definitive studies to determine whether any intervention, not just this one, is truly safe and effective,” Fauci told Fox News on April 3.

Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, addresses the coronavirus task force daily briefing at the White House in Washington, U.S., March 24, 2020.

Jonathan Ernst | Reuters

To pass the Food and Drug Administration’s muster and win approval for widespread use, the drug will need to undergo rigorous clinical trials with thousands of participants, according to the agency’s guidelines.

The NYU-UW study will enroll at least 2,000 patients ages 18 to 80, Bershteyn said. Researchers realize that people over 80 are at a high risk of developing severe Covid-19 symptoms and would likely benefit from a potential treatment, she said.

“But right now, we have no idea if this drug does anything at all in the context of Covid-19,” she said. 

Side effects

Hydroxychloroquine, which is available as a generic drug and is also produced under the brand name Plaquenil by French drugmaker Sanofi, can have serious side effects, including muscle weakness and heart arrhythmia. A small study in Brazil was halted this month for safety reasons after coronavirus patients taking chloroquine, which hydroxychloroquine is derived from, developed arrhythmia, including some who died.

“Because older populations tend to have more heart problems, we don’t want to put anyone in harm’s way for a drug that might not work,” Bershteyn said. “If the drug turns out to have a benefit, then it comes to each patient weighing the risk versus the benefits.”

June or July

The NYU-UW Researchers have been moving quickly to finish the study by June or July, Bershteyn said. Writing the procedure, protocols and getting approval from the Institutional Board of Review usually takes months, but they did it in weeks, she said.

The study is very “focused,” she said, seeking to use the drug for what is called preexposure prophylaxis.

“It’s not a new idea,” she said, adding that anti-viral drugs work quite well in treating HIV, a virus that was once thought of as a death sentence. “If a medical worker gets pricked by a needle from somebody who has HIV, they will be offered anti-HIV drugs and if those drugs are started quite soon after the exposure, often they will prevent the person from becoming infected at all.”

Pandemic challenges

Conducting a clinical trial amid this pandemic comes with unique challenges, she said. All interactions between the researchers and patients will be done virtually instead of in person. Patients are also being asked to take nasal swabs and send them to the lab for testing to protect physicians from exposure to the virus. Researchers also want the study to be as standardized as possible. All testing sites are using the same materials and the specimens are going back to the same lab, she said.

Whether the drug works or not, the next question will be “what else could work?” she said. 

“Even if hydroxychloroquine turns out to be effective, you always want to have another tool, especially against a virus because we know they can develop resistance against a drug,” she said. “So, even if we’re very lucky and hydroxychloroquine works well, we would still need to be testing what the next drug could be for this purpose.”

Parallel studies

While NYU and UW conducts the formal clinical study, the University of Albany researchers are conducting a parallel observational study. They are examining the medical records of Covid-19 patients who have been discharged from the hospital or have died to see what was prescribed and what may have been effective.

Researchers will be looking for how often the drug was prescribed by physicians and whether it was used in combination with other drugs such as Azithromycin, commonly known as a Z-Pak. They’ll also be watching for side effects and whether there’s any evidence of positive or negative outcomes, Holtgrave said.

“It’s going to take a little time to find what the prescribing behavior of the physicians are like,” he said. “Do they prescribe more of that or less of that. That may change.”

Holtgrave ordered his first batch of medical records two weeks ago. Before they arrive, they will need to be sent to an intermediary company, or medical extraction firm, where patients’ personal information will be removed, he said. He hopes to have several hundred cases to begin his analysis.

Moving as fast as we can

“Our goal is in the month of April we should be able to have at minimum, two data polls, three if we need it, and then still have just a little time on the last week of April to do some data analysis,” he said.

While not as “rigorous” as a randomized controlled trial, it is “timely,” he said.

“I think we’re trying to move as fast as we possibly can,” he said.

“Given the urgency to try and address Covid, you would like to do a big gold-standard randomized controlled trial with huge numbers of people in the study, and you’d like to be done by the end of today and analyze the data tonight and be ready to go,” he said. “And of course, it is impossible to do that.”

He said it’s important to recognize the contribution physicians and other health-care workers are doing on the front lines.

“We think Covid-19 is such a very serious public health challenge,” he said. “We’re hopefully moving on this observational study in a way that hits on this sort of timeliness that is necessary to get these kinds of answers just as quickly as we possibly could.”

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