The National Institutes of Health’s decision to release early findings on remdesivir bodes well for the antiviral drug’s future as a weapon against COVID-19, University of Rochester Medical Center researchers say. The URMC team is running a local clinical trial of the drug.
As reported by the Rochester Beacon roughly two months ago, researchers identified remdesivir as a likely treatment for COVID-19 in the pandemic’s early stages. Until now, however, they lacked scientifically verified proof of its effectiveness.
In an announcement, NIH revealed that patients receiving remdesivir in controlled double-blind trials had a 31 percent faster time to recovery than those who received a placebo. Specifically, the median recovery time for remdesivir recipients was 11 days versus 15 days for placebo recipients. Remdesivir recipients also had a higher rate of survival—an 8 percent mortality rate versus 11.6 percent for the placebo group.
Findings of the ongoing, 16-patient local remdesivir double-blind trial are not known by the URMC team. The group does not know which patients in the local trial have been given placebos, says the trial’s co-leader, Anne Falsey M.D. However, she adds, the fact that the independent data and safety board monitoring the more than 1,000-patient international trial decided to release preliminary results shows that the board has some confidence in the drug’s effectiveness.
In a televised announcement Wednesday, Anthony Fauci M.D., director of NIH’s National Institute of Allergy and Infectious Diseases, called the data released with independent board’s review of the trial’s result “really quite important.”
The numbers revealed by the trial’s early results might seem less than impressive, Fauci said, but the results for the first time offer scientifically verified proof that a drug can block the virus. The remdesivir group’s improved survival rate is not statistically significant, he cautioned. But it still offers “clear evidence” of the drug’s effectiveness.
Fauci, who was a key figure in spurring NIH’s AIDS research, compared the initial remdesivir results to early findings on the AIDS drug AZT. Those findings showed only slight improvement but provided a “building block” that ultimately led to a so-called cocktail of several drugs that have virtually tamed the AIDS virus, turning the AIDS infection from a virtual death sentence to a manageable chronic condition.
Fauci said he was moved to announce the preliminary remdesivir results on ethical grounds so that COVID-19 patients not enrolled in a clinical trial could request the drug on compassionate-use grounds. Remdesivir manufacturer Gilead Sciences Inc. announced a compassionate use remdesivir program in mid-April. UR Medicine has dispensed the drug to some COVID-19 patients outside of the clinical trial on those grounds. It is not currently doing so but expects to do so again.
URMC is slated to begin a second remdesivir clinical trial in which participants are to also be treated with baricitimib, an anti-inflammatory used to treat rheumatoid arthritis, Falsey says.
Baricitimib is marketed by Eli Lilly and Co. under the brand name Olumiant. In an April 10 news release, Lilly said that the company, along with NIH’s NIAID, was beginning phase II trials of remdesivir combined with baricitimib as a possible treatment for a subset of COVID-19 patients. In those patients, the coronavirus triggers an effect called an inflammatory cascade in which patient suffer ill effects from attacks by their own immune systems.
Because it works by suppressing patients’ immune response, baricitimib carries a risk of exposing patients to serious infections including tuberculosis and fungal infections as well as cancer. According to Lilly, most patients who suffer such effects are also taking other immune-system suppressants.
Will Astor is Rochester Beacon senior writer. All Rochester Beacon coronavirus articles are collected here.