Fauci: Results from COVID-19 drug trial that began in Omaha ‘quite good news’ | Health

From staff and wire reports

Scientists on Wednesday announced the first effective treatment against the coronavirus — an experimental drug that can speed the recovery of COVID-19 patients — in a major medical advance.

The U.S. government said it is working to make the antiviral medication remdesivir available to patients as quickly as possible, the Associated Press reported.

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

Fauci, the head of National Institute of Allergy and Infectious Diseases, said early results of the clinical trial of remdesivir offered “quite good news.”

The U.S. Food and Drug Administration has been talking with the drug manufacturer, Gilead Sciences, about making remdesivir available to patients as quickly as possible.

A clinical trial of the drug began in Omaha in February. The trial has found that hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received a placebo.

That’s according to an analysis of preliminary data from the randomized, controlled trial involving 1,063 patients.

The first participant in the trial was an American who was repatriated after being quarantined on the Diamond Princess cruise ship that docked in Yokohama, Japan. The person volunteered to participate in the study at the Nebraska Medical Center, the first study site, in February.

Sixty-eight sites ultimately joined the study — 47 in the United States and 21 in countries in Europe and Asia.

An independent data and safety monitoring board overseeing the trial met Monday to review data and shared their interim analysis with the study team, the National Institutes of Health said in a press release. Based on their review of the data, the board noted that remdesivir was better than a placebo from the perspective of the primary endpoint, time to recovery, a metric often used in influenza trials. Recovery in this study was defined as being well enough to be discharged from the hospital or returning to a normal activity level.

Preliminary results indicate that patients who received remdesivir had a 31% faster time to recovery than those who received a placebo. Specifically, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of 8% for the group receiving remdesivir versus 11.6% for the placebo group.

More detailed information about the trial results, including more comprehensive data, will be available in a forthcoming report.

Finding a treatment for COVID-19, the disease caused by the novel coronavirus, could move the world closer to easing lockdown measures put in place to help slow its spread. News of the positive results helped send the U.S. stock market soaring Wednesday despite data showing a deep contraction in the economy in the first quarter of the year, Bloomberg reported.

Gilead shares jumped as much as 8.1% Wednesday after the company’s statement.

The broader stock market and Gilead itself have been churned in recent weeks by a series of early looks and leaks of trial data on the drug. Last week, the market swooned after apparently discouraging results from a Chinese trial that was halted early after researchers struggled to enroll patients were accidentally posted on a World Health Organization web page.

Data confirming those more downbeat results were published in the U.K. medical journal The Lancet on Wednesday. Fauci said at the White House Wednesday that that trial was “not an adequate study.”

Originally developed to treat other novel viruses, remdesivir has placed Gilead at the head of the race to develop a treatment for COVID-19. The drug, which also has been tested on Ebola, isn’t approved for use anywhere in the world.

A separate study of 397 patients released by Gilead on Wednesday found remdesivir appears equally effective when given for half as long as the 10 days used in the NIAID and other studies, and that some patients may fare even better when given less medication. The potential ability to treat patients for less time would help ease strain on stretched health systems that must infuse the medicine, and make supplies of the drug last longer.

Two weeks after treatment, 65% of those who got the five-day dose had recovered, compared with just 54% of those who received the infusion for 10 days. The death rate showed a similar trend, with 8% of patients getting less drug dying, compared with 11% in the 10-day group. The difference wasn’t statistically significant, which means it could have happened by chance.

The five-day regimen “could significantly expand the number of patients who could be treated with our current supply of remdesivir,” said Merdad Parsey, Gilead’s chief medical officer.

Taken together, Gilead’s study and the NIAID trial could signal a profound shift in the race to get the novel coronavirus under control. The availability of a treatment could allow the world to start reopening economies, as well as offer psychological relief to billions of people who have been self-isolating to hide from the virus.

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