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Study finds drug tested at UVA Health proved effective against COVID-19

In this March 2020 photo provided by Gilead Sciences, a vial of the investigational drug...
In this March 2020 photo provided by Gilead Sciences, a vial of the investigational drug remdesivir is visually inspected at a Gilead manufacturing site in the United States. Given through an IV, the medication is designed to interfere with an enzyme that reproduces viral genetic material. (Gilead Sciences via AP)(WHSV)
Published: Apr. 30, 2020 at 9:38 AM EDT
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April 30:

An antiviral drug that's been part of a worldwide study on possible COVID-19 treatments proved effective at speeding up recovery, according to UVA Health, which was a part of the study.

Remdesivir, tested against COVID-19 at UVA and 67 other hospitals around the world, helped patients with advanced cases recover 31% faster than patients who received a placebo, the National Institutes of Health reports.

According to the NIH, the drug also appeared to improve survival among participants in the trial.

Across those taking the drug, the median recovery time for patients was 11 days, compared with an average of 15 days for those who received the placebo, according to preliminary data released by the NIH.

When it comes to mortality, 11.6% of placebo recipients died, compared with 8% of remdesivir recipients.

“This is the first clinical trial to demonstrate an effective treatment for COVID-19,” said Patrick Jackson, MD, the principal investigator of the trial at UVA. “Remdesivir will be one tool we can use to turn the tide of this pandemic.”

For the study’s purposes, “recovery” was defined as being well enough to leave the hospital or return to normal activities.

The NIH said it would release additional details in a forthcoming report, but it did not specify when the report would be released.

“I’m extremely proud for the clinical research staff, pharmacists and others who helped us launch this trial in record time,” said Taison Bell, MD, a UVA critical care and infectious disease specialist. “Because of their efforts, we were able to get a win for our community in the fight against COVID-19.”

About the trial

The trial was the first of a potential medication to treat COVID-19 in the United States. Patients could enroll until April 19, and a total of 1,063 did. The trial was randomized and controlled, according to the NIH.

Hospitalized adult patients with COVID-19 and significant symptoms – including difficulty breathing, using supplemental oxygen or needing a ventilator – were eligible to participate. Participants were randomly assigned either remdesivir or a placebo intravenously for as long as 10 days. All other care followed the usual standards.

After the initial trial results, remdesivir will move into a second phase of testing, in which it will be compared to another drug, baricitini, to determine which is the most effective treatment option.

“It is vital we find effective treatments for this very serious illness,” said K. Craig Kent, MD, UVA’s executive vice president for health affairs. “I’m proud UVA has been part of this trial, and I have deep gratitude for all the researchers and care providers who are working tirelessly in the battle against COVID-19.”

National response

The U.S. government said on Wednesday that it is working to make the antiviral medication remdesivir available to patients as quickly as possible.

"What it has proven is that a drug can block this virus," said Dr. Anthony Fauci, the government's top infectious-disease expert. "This will be the standard of care."

California-based biotech company Gilead Sciences, responsible for the drug, and the U.S. government reported the NIH results showing that it shortened the time it takes for COVID-19 patients to recover by four days on average.

Stocks surged around the world on the news, with the Dow Jones Industrial Average gaining more than 530 points on the day, or over 2%.

An effective treatment could have a profound effect on the outbreak, since a vaccine is probably a year or more away.

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Original story

UVA Health has joined a national clinical trial that allows COVID-19 patients to choose to receive a medication being evaluated as a possible treatment.

According to a statement released by the hospital on Thursday, the trial is testing the safety and effectiveness of remdesivir, an antiviral drug that has previously been tested in humans with Ebola virus.

They say it's shown promise, in animal studies, against Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), which are each diseases caused by different types of coronavirus.

“Finding an effective treatment will be incredibly important in our battle against COVID-19,” said K. Craig Kent, MD, UVA’s executive vice president for health affairs. “I am pleased that UVA is a part of this valuable study.”

Patients who are hospitalized in the UVA Health system with COVID-19 and significant symptoms — including difficulty breathing, using supplemental oxygen or needing a ventilator — can now sign up for the trial.

Participants are randomly assigned either remdesivir or a placebo drug. The drug will be administered via IV for as long as 10 days.

Per standard procedure for medical trials like this, neither the participant nor their doctor will know if they are receiving the medication or a placebo.

The patient will otherwise receive the current standard of care for COVID-19 patients, based on their symptoms. Each day, UVA doctors will assess any changes in their condition.

The trial involves a number of hospitals an an estimated 440 participants around the world. Data from all patients involved will be combined and analyzed about halfway through the trial's enrollment period to determine if any changes need to be made.

Depending on the status of the trial at that point, it could be stopped if no benefits are seen, or it could be changed to add another medication or therapy that could improve participants’ response.

“Having scientifically sound information about the effectiveness of remdesivir will be helpful as we seek to provide the best care for patients,” said Patrick Jackson, MD, the principal investigator for the trial at UVA.

The National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health, is funding the study. Gilead Sciences Inc., which developed remdesivir, is supplying it for the study.

"Bringing the Remdesivir trial to UVA is a true testament to our collaborative spirit,” said Taison Bell, MD, a UVA critical care and infectious disease specialist. "Before I spoke to Dr. John Beigel [the principal investigator for the entire trial], we had already lined up the research staff and infrastructure to hit the ground running. He was impressed with our organization, and we were able to start moving immediately.”