In a promising development on Wednesday, President Donald Trump and Dr. Anthony S. Fauci described a study of an experimental virus drug, Remdesivir, as “very optimistic” and “quite good news” in treating coronavirus.
“It’s a positive; it’s a very positive event,” Trump said.
“The data shows that Remdesivir has a clear-cut, significant positive effect in diminishing the time to recovery,” said Fauci, the director of the National Institute of Allergy and Infectious Diseases.
In a statement issued Wednesday morning, Gilead Sciences, Inc., a Foster City, California-based biopharmaceutical company, said it is aware of “positive data” emerging from the National Institute of Allergy and Infectious Diseases’ (NIAID) study of the investigational antiviral Remdesivir for the treatment of COVID-19.
The study suggests that the drug could become the first effective treatment for an illness that has killed over 225,000 people worldwide, sent the American and global economy into a tailspin, and turned modern-day life upside down.
“Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, Marburg, MERS and SARS,” Gilead said in a statement.
“In vitro testing conducted by Gilead has demonstrated that Remdesivir is active against the virus that causes COVID-19. The safety and efficacy of Remdesivir for the treatment of COVID-19 are being evaluated in multiple ongoing Phase 3 clinical trials.”
A National Institutes of Health statement issued Wednesday morning said hospitalized patients with advanced COVID-19 and lung involvement who received Remdesivir recovered faster than similar patients who received placebo, according to a preliminary data analysis from a randomized, controlled trial involving 1,063 patients, which began in late February.
The trial (known as the Adaptive COVID-19 Treatment Trial, or ACTT), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is the first clinical trial launched in the United States to evaluate an experimental treatment for COVID-19.
“An independent data and safety monitoring board (DSMB) overseeing the trial met on April 27 to review data and shared their interim analysis with the study team,” the NIH said in the statement. Based upon their review of the data, they noted that Remdesivir was better than 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 for hospital discharge or returning to normal activity level.
“Preliminary results indicate that patients who received Remdesivir had a 31 percent faster time to recovery than those who received 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 percent for the group receiving Remdesivir versus 11.6 percent for the placebo group.”
More detailed information about the trial results, including more comprehensive data, will be available in a forthcoming report.
“As part of the U.S. Food and Drug Administration’s commitment to expediting the development and availability of potential COVID-19 treatments, the agency has been engaged in sustained and ongoing discussions with Gilead Sciences regarding making Remdesivir available to patients as quickly as possible, as appropriate,” the NIH said in the statement.
Currently, there are no approved treatments or vaccines for the highly contagious Coronavirus, but several approaches are being attempted while awaiting an effective vaccine to prevent COVID-19.