Lipid-Lowering Drug TriCor Dramatically Reduces Treatment Time For Patients With Severe COVID-19

The SARS-CoV-2 virus has infected more than 165 million people worldwide, causing nearly 3.5 million deaths. Recent vaccination efforts have been hampered by multiple variants of the coronavirus that challenge current vaccines. While the infection usually produces mild illness, in some patients it can develop into severe inflammatory COVID-19 requiring medical intervention.

Recently, the team of Professor Yaakov Nahmias at the Hebrew University of Jerusalem (HU) reported that the new coronavirus causes an abnormal buildup of lipids, which are known to trigger severe inflammation in a process called lipotoxicity. The team identified the lipid-lowering drug TriCor (fenofibrate) as an effective antiviral last year, showing that it both reduced damage to lung cells and blocked virus replication in the lab. These results have since been confirmed by several international research teams. An observational study conducted in several clinical centers in Israel was reported last October to support the original findings. The team then launched an interventional clinical study to treat patients with severe COVID-19 at Israel’s Barzilai Medical Center with support from Abbott Laboratories.

Today, the HU team reports the promising results of an open-label interventional clinical study initiated by a researcher, led by Nahmias and coordinated by Professor Shlomo Maayan, head of the infectious diseases unit at Barzilai. In this open-label, single-arm study, 15 hospitalized COVID-19 patients with severe pneumonia requiring oxygen support were treated. In addition to standard care, patients received 145 mg / day of TriCor (fenofibrate) for 10 days and continuously monitored for disease progression and outcomes. “The results have been amazing,” Nahmias shared. “Progressive inflammation markers, which are the hallmark of deterioration of COVID-19, fell within 48 hours of treatment. Additionally, 14 of 15 severe patients did not require oxygen support. within a week of treatment, while historical records show that the vast majority of severe patients treated with standard care require long-term respiratory support, ”he added. These results are promising because TriCor (fenofibrate) was approved by the FDA in 1975 for long term use and has a strong safety record. “There is no silver bullet,” Nahmias pointed out, “but fenofibrate is much safer than other drugs on offer to date, and its mechanism of action is less likely to be variant specific.” .

All patients were discharged within a week of starting treatment and were able to complete the 10-day treatment at home, with no drug-related adverse events reported. Additionally, fewer patients reported side effects from COVID-19 during their 4-week follow-up appointment. “

Prof. Shlomo Maayan, Head of Infectious Diseases Unit at Barzilai

These preliminary results promise to alleviate the substantial health burden suffered by patients who survive the acute phase of COVID-19.

The researchers pointed out that although the results were extremely promising, only randomized, placebo-controlled studies can be used as a basis for clinical decisions. “We have entered the second phase of the study and are actively recruiting patients,” Nahmias explained, noting that two phase 3 studies are already being conducted in South America, the United States (NCT04517396) and Israel (NCT04661930 ).

The findings were released on Research Square and are currently under peer review.