Kettering Health Network announced on Thursday that the hospital will participate in an expanded access clinical trial for the antiviral drug remdesivir, which has shown in preliminary trials helps coronavirus patients recover faster.
Dr. Patrick Lytle, vice president of clinical outcomes for Kettering Health, said the health network is “thrilled” to be part of the clinical trial.
“When we were given the opportunity, we jumped at this,” Lytle said. “We wanted to be a leader in the community and we wanted to give back to the community, so if this is something that we can help provide our patients we’re all in.”
Lytle said the intravenous drug was originally developed to treat Ebola. There have been studies in China, Europe and the United States on the drug.
“It shortens the lifespan of the virus,” Lytle said.
The maker of remdesivir, Gilead Sciences, reported Wednesday that early results of a test trial showed earlier recovery in patients treated with the antiviral drug as compared to a placebo. In a study of more than a thousand patients sick enough to be hospitalized, remdesivir shortened the time to recovery to 11 days on average versus 15 days for those just given usual care.
MORE: US study finds Gilead drug works against coronavirus
Lytle said only the sickest patients at Kettering Medical Center will get the drug. Patients must be on a ventilator and have reasonable organ function, because the drug can affect the liver. Patients who meet that criteria will be given remdesivir once a day.
“Once a patient is on a respirator, their mortality chances go up, so having something that can help turn that around is truly a game changer and it’s an honor to participate in a national study,” Lytle said.
National Institutes of Health’s Dr. Anthony Fauci said he expects remdesivir to be “really quickly” approved by the U.S. Food and Drug Administration.
A statement from the Food and Drug Administration says that the agency has been talking with Gilead “regarding making remdesivir available to patients as quickly as possible, as appropriate.”
Gilead said it was ramping up production and aims to have more than 140,000 treatment courses by the end of May, more than 500,000 by October and more than 1 million by December.
Premier Health is not part of the clinical trial, but said it has administered the drug to some coronavirus patients. Premier Health has been participating the the Mayo Clinic’s clinical trial of using plasma of those who had recovered from the coronavirus to treat those with the illness.
“Premier Health has sought to partner with various organizations to respond vigorously to the COVID-19 pandemic, including in the area of clinical trials,” said a Premier Health spokesman. “Premier Health, for example, was the first U.S. hospital system to administer convalescent plasma treatment using the Mayo Clinic’s protocols. As part of our compassionate care protocols, we have also administered remdesivir, Soliris (an immunosuppressant), and Tocilizumab (also an immunosuppressant).”
Premier Health has been working with the Community Blood Center to build a roster of people able to donate plasma. As of Tuesday, April 28, Miami Valley Hospital’s research arm had screened 300 potential donors and 32 donors were sent to the Community Blood Center to donate plasma, plus three from Wright Patterson Air Force Base.
Fauci said that any other potential coronavirus treatments will now have to be tested against or in combination with remdesivir.
Gilead also is testing remdesivir in a separate study of moderately ill coronavirus patients. No results have yet been announced from that study, which does have a comparison group.
Besides these studies, Gilead also has given remdesivir to more than 1,700 patients on a case-by-case emergency basis.
No drugs are currently approved for treating the coronavirus, which has killed about 226,000 people worldwide since it emerged late last year in China. An effective treatment could have a profound effect on pandemic’s impact, especially because a vaccine is likely to be a year or more away, according to health experts.
MORE: Fauci expects quick approval of new virus drug
Fauci said he expects remdesivir to be “really quickly” approved by the U.S. Food and Drug Administration.
The other Kettering Health Network hospitals caring for coronavirus patients are in the process of applying for the remdesivir trial. Lytle said the other hospitals will soon be able to provide this drug to their sickest patients, too.
About the Author
