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DHMC trials helped clear a drug used to treat Trump for COVID-19

Valley News Staff Writer
Published: 10/6/2020 5:33:48 PM
Modified: 10/6/2020 5:33:40 PM

LEBANON — An antiviral drug that President Donald Trump has been taking as part of his treatment for COVID-19 was cleared for use on patients hospitalized with the coronavirus earlier this year after clinical trials conducted at Dartmouth-Hitchcock Medical Center and other hospitals collectively showed some promising results.

DHMC was an early testing site in March for COVID-19-related clinical trials of remdesivir, an antiviral drug that originally was used from 2013 to 2016 to combat the West African Ebola virus.

Trump was slated to take his fifth and final dose of remdesivir on Tuesday evening at the White House, Dr. Brian Garibaldi, a pulmonary critical care doctor at Walter Reed National Military Medical Center in Bethesda, Md., said during a news conference on Monday. The president was treated at Walter Reed for three nights before returning to the White House, which has its own medical unit, on Monday.

In March of this year, DHMC became one of the first 20 sites to join clinical trials of remdesivir, which is manufactured by California-based Gilead Sciences, in treating patients with COVID-19, said Dr. Richard Zuckerman, a D-H infectious disease and international health specialist. The number of sites involved in the trials eventually grew to about 97.

“It was all hands on deck to make sure we could take care of the population,” Zuckerman said in a Monday phone interview.

Results from studies including those DHMC participated in led the U.S. Food and Drug Administration to deem remdesivir an “important treatment,” he said. Overall, such studies have shown that the drug may reduce the length of illness and its severity, Zuckerman said.

Remdesivir, which is delivered intravenously to hospitalized patients, acts by inhibiting viral reproduction, he said.

DHMC participated in two “phase 3” clinical trials of remdesivir through Gilead Sciences. One trial sought to understand the drug’s effect on patients with COVID-19 who were severely ill and on oxygen, Zuckerman said. The second examined the drug’s effect on moderately ill patients, he said.

The studies, which compared five- and 10-day dosing durations, sought to determine the safety and efficacy of the drug.

Due to patient privacy concerns, Zuckerman said he couldn’t say how many DHMC patients had been involved in the studies. The study of people with severe illness initially enrolled a total of 400 patients across sites, and then grew to allow 5,600 additional patients to enroll, according to Gilead. The study of people with moderate illness initially enrolled 600 patients and subsequently allowed another 1,000 patients to enroll.

The research differed from non-pandemic-related work, Zuckerman said, noting that findings from studies of COVID-19 treatments have come out in press releases first and then in peer-reviewed journals, which is the opposite of the normal process.

“The research operations, they just move a lot faster (in a pandemic),” he said.

The first results of the Gilead trial of severe cases were reported in late April and showed no difference in effectiveness between the five-day and 10-day courses of treatment. The study also showed that patients seemed to do better when they received remdesivir within the first 10 days of developing symptoms due to COVID-19, rather than later in their illness.

“By Day 14, 62% of patients treated early were able to be discharged from the hospital, compared with 49% of patients who were treated late,” according to a April 29 news release by Gilead. The findings of the study of patients with severe illness were published in the New England Journal of Medicine in May.

A trial conducted around the same time by the National Institute of Allergy and Infectious Diseases showed in preliminary results “that patients who received remdesivir had a 31% faster time to recovery than those who received placebo.”

Those results also were published in the New England Journal of Medicine in May.

And Zuckerman said he expects more information will be forthcoming.

“All the data hasn’t been published,” he said.

Due to the promise the drug showed in the early trials, the FDA issued an emergency use authorization to allow doctors to use remdesivir to treat patients with COVID-19. The FDA issued its first such authorization for remdesivir on May 1, allowing doctors to use it to treat patients with severe illness. In August, the FDA expanded its authorization to allow the use of the drug in all hospitalized adult and pediatric patients with COVID-19.

The drug does come with some risks. Because of the negative effects remdesivir can have on the liver and kidneys, it is not appropriate for patients with severe liver or kidney disease or for pregnant patients, Zuckerman said. Before administering remdesivir, doctors discuss the benefits and risks with patients and families, he said.

Clinicians have to be “very careful” in their approach to using treatments before they’ve gone through the usual formal review for drugs, Zuckerman said. At DHMC, he said clinicians “met and still do meet regularly to discuss what we feel are the best treatments to add for our patients; for the health system.”

They “have to be very thoughtful about reviewing the data,” he said.

At DHMC, remdesivir is a tool clinicians have at their disposal to help hospitalized patients with COVID-19 recover. Other tools include the steroid dexamethasone — which also has been part of the president’s treatment — supplemental oxygen and convalescent plasma, Zuckerman said.

During the course of the pandemic, Zuckerman said DHMC providers have “learned a lot about how to care for the patients.”

Nora Doyle-Burr can be reached at ndoyleburr@vnews.com or 603-727-3213.




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