An Israeli study has found that the antiviral FDA-approved drug called Fenofibrate (Tricor), an oral medication to help lower cholesterol by treating abnormal blood lipid levels, has also lowered severe progressive inflammation markers in hospitalized COVID-19 patients within 48 hours of treatment.
The “extremely promising” results are based on an investigator-initiated interventional open-label clinical study led by Prof. Yaakov Nahmias of The Hebrew University of Jerusalem, in cooperation with Prof Shlomo Maayan, Head of the Infectious Disease Unit at Barzilai Medical Center in the southern city of Ashkelon.
Last year, Professor Yaakov Nahmias and his team at HU partnered with a team of American scientists led Dr. Benjamin tenOever, a professor of medicine and microbiology and the director of the Virus Engineering Center for Therapeutics and Research at Mount Sinai Medical Center’s Icahn School of Medicine in New York, to carry out lab tests that showed the lipid-lowering drug Tricor was effective in reducing lung cell damage and blocking virus replication.
These results were confirmed by several international research teams and an observational study was carried out in multiple clinical centers in Israel, a Hebrew University statement said. After the study last October, the team launched an interventional clinical study to treat severe COVID-19 patients at Israel’s Barzilai Medical Center with support from Abbott Laboratories.
As part of this study, 15 severe-hospitalized COVID-19 patients with pneumonia requiring oxygen support were treated at the Ashkelon hospital. In addition to the usual standard of care, patients were also given 145 mg a day of Fenofibrate (Tricor) for 10 days and continuously monitored for disease progression and outcomes.
The results were released on Research Square, a multidisciplinary preprint and author services platform where professors, doctors, and students can share their work before they look to publish it in a scientific journal.
According to Nahmias, results were “astounding.”
“Progressive inflammation markers, that 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, while historical records show that the vast majority severe patients treated with the standard of care require lengthy respiratory support,” he said in the statement.
Treating severe symptoms
Most people who become infected with the coronavirus will go through a mild illness. In some cases, they will need antibiotic treatment to overcome pneumonia, Prof. Nahmias tells NoCamels. Only in severe cases, where age and other complications are a factor, will patients experience severe pneumonia and respiratory distress which will need oxygen support. Even in severe cases, with proper care, and with enough beds, ventilators and nurses, the vast majority of patients will recover within a few weeks. All of this must be taken into account when reporting a potential cure for corona, Prof. Nahmias explains. Treatment of mild or moderate coronavirus patients will not statistically show significant results, because even so, they recover within a few days.
“This is why we insisted on conducting the study in severe coronavirus patients who need respiratory support. In the vast majority of these patients, CRP remains high (a marker of inflammation) for more than a week. The ratio of neutrophils to lymphocytes (NLR) rises above six within a few days of hospitalization and indicates an excessive immune response,” he says.
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When the team treated patients with Fenofibrate (Tricor) at 145 mg a day, “CRP in our patients dropped within 48 hours and NLR did not rise at all,” Nahmias says, “That is, we stopped the progression of the disease.” While every patient was required to have oxygen when each one entered the study, in less than a week there was evidence that 93.3 percent of patients no longer required it.
“Even when we brought the patients after a month for an audit, surprising results were recorded. Only one patient reported symptoms of long COVID,” he adds.
These results are encouraging because Fenofibrate (Tricor) was approved by the FDA in 1975 for longterm use and has a strong safety record, according to Prof. Nahmias.
Also, Fenofibrate, an approved drug for longterm use in blood lipids, has no significant side effects, unlike antiparasitic drugs like hydroxychloroquine or ivermectin, he adds. Ths is especially true within short term use.
“This means that it will also be possible to prescribe the drug to patients who do not suffer from a serious illness,” Prof. Nahmias says.
On his Facebook page, Prof. Nahmias notes (in separate English and Hebrew posts) that Fenofibrate is an affordable, cost-effective solution, with an entire course of short term treatment costing less than $15 per patient or $1.5 a day.) The issue is that it is not included in the country’s local healthcare basket of medications that the healthcare system is required to provide by law in favor of cheaper drugs from the same family that treat lipid conditions but don’t necessarily treate the novel coronavirus.
It should be, Prof. Nahmias admits. “This isn’t an expensive peptide or fancy cell therapy that would cost the [Israeli] healthcare system an arm and a leg,” he writes.
While Prof. Nahmias believes vaccinations are the best method to protect oneself from COVID-19, he says there are still going to be severe COVID-19 patients every year, similar to patients hospitalized for influenza despite receiving a flu vaccine.
“This is where drugs like Fenofibrate come into play, making sure that we have weapons in our arsenal to keep people from dying after we did everything in our power to prevent infection in the first place,” he writes.
Investigators are currently in the second phase of their study and are actively recruiting patients, Prof. Nahmias says. In the meantime, two Phase III studies are already being conducted in South America, the United States, and Israel.