Fourteen out of 15 severe COVID-19 patients who were treated in an investigator-initiated interventional open-label clinical study of the drug TriCor (fenofibrate) didn’t require oxygen support within a week of treatment and were released from the hospital, according to the results of a new Hebrew University of Jerusalem study.
Fenofibrate is an FDA-approved oral medication. The results were published on Researchsquare.com and are currently under peer review.
Specifically, the team that was led by HU’s Prof. Yaakov Nahmias carried out the study at Israel’s Barzilai Medical Center in coordination with the hospital’s head of the Infectious Disease Unit, Prof. Shlomo Maayan, and with support from Abbott Laboratories.
The 15 treated patients all had pneumonia and required oxygen support. They were also older with multiple comorbidities, ranging from diabetes and obesity to high blood pressure.
In addition to standard of care, the patients were given 145 mg/day of fenofibrate for 10 days.
“The results were dramatic,” Nahmias told The Jerusalem Post. “Progressive inflammation markers, which are the hallmark of deteriorative COVID-19, dropped within 48 hours of treatment. Moreover, 14 of the 15 severe patients didn’t require oxygen support within a week of treatment.” The 15th patient was off oxygen within 10 days.
When looking at the data on other similar severe patients, less than 30% of them on average are removed from oxygen support within a week. In other words, fenofibrate could dramatically shorten the treatment time for severe COVID patients.
“We know these kinds of patients deteriorate really fast, develop a cytokine storm in five to seven days and that it can take weeks to treat them and for them to get better,” Nahmias said. “We gave these patients fenofibrate and the study shows inflammation dropped incredibly fast. They did not seem to develop a cytokine storm at all.”
Cytokine storms are aggressive inflammatory responses to illness.
In general, patients who do not require oxygen can be treated at home,” he said. “Additionally, despite the high number of COVID deaths in Israel and abroad, the majority of severely sick patients survive.
“If you look over a 28-day period, I would have expected all of them to survive with or without the drug,” Nahmias explained. “The question is how fast we can get them home or how quickly we can get a severe patient to a mild condition.”
All of the patients completed a 10-day home treatment after discharge and, according to Maayan, “no drug-related adverse events” were reported.
FENOFIBRATE WAS approved by the FDA back in 1975 for long-term use and is considered safe. Moreover, it is an inexpensive pill, Nahmias said. It costs less than $1.50 a day, meaning the entire treatment per patient was around $15.
Nahmias has been studying the use of fenofibrate for treating COVID-19 almost since the start of the pandemic. He first ran a pre-clinical trial and then a multi-center retrospective study, both of which supported the effectiveness of the drug.
“Viruses are parasites,” Nahmias explained. “They cannot replicate by themselves. They have to get inside a human cell and hijack their machinery to replicate.”
Working with collaborators in the United States, Nahmias demonstrated that the coronavirus prevents the burning of fat in lung cells, resulting in large amounts of fat accumulating inside lung cells – a condition the virus needs to reproduce. Fenofibrate, he hoped, would reverse that effect, and eliminate virus replication.
“By understanding how the SARS-CoV-2 controls our metabolism, we can wrestle back control from the virus and deprive it of the very resources it needs to survive,” Nahmias told the Post, noting that this also may help explain why patients with high blood sugar and cholesterol levels are often at a particularly high risk to develop COVID-19.
The professor is now involved with a series of Phase III studies being carried out in South America, the United States and Israel. Those studies are placebo-controlled and double-blind.
Nahmias said his team had been struggling to get patients enrolled in the study before the onset of the Delta variant, but efforts are now progressing more rapidly. He hopes that results could be available as early as within the next two months.
In the meantime, the drug is available, and physicians can decide to give treatment with it based on available data.
“There are no silver bullets,” he said, “but fenofibrate is far safer than other drugs proposed to date, and its mechanism of action makes it less likely to be variant-specific.”
In the meantime, the drug is available, and physicians can decide to give treatment with it based on available data.
“There are no silver bullets,” he said, “but fenofibrate is far safer than other drugs proposed to date, and its mechanism of action makes it less likely to be variant-specific.”