A team at the Hebrew University of Jerusalem (HU) is reporting “astounding” results from a trial to check the efficacy of the lipid-lowering drug TriCor (fenofibrate) as a treatment for patients with severe Covid-19.
In earlier research, the team at HU, lead by Professor Yaakov Nahmias, reported that the new coronavirus causes abnormal accumulation of lipids, which are known to initiate severe inflammation in a process called lipotoxicity. Last year the team identified the lipid-lowering drug TriCor (fenofibrate) as an effective antiviral, showing it both reduced lung cell damage and blocked virus replication in the laboratory. These results have since been confirmed by several international research teams. An observational study carried out in multiple clinical centres in Israel was reported last October to support the original findings. The team then launched an interventional clinical study to treat severe Covid-19 patients at Israel’s Barzilai Medical Center with support from Abbott Laboratories.
Now, the HU team is reporting promising results from this trial – an investigator-initiated interventional open-label clinical study led by Nahmias and coordinated by Prof. Shlomo Maayan, Head of Infectious Disease Unit at Barzilai. In this single-arm, open-label study, 15 severe-hospitalized Covid-19 patients with pneumonia requiring oxygen support were treated. In addition to standard of care, the patients were given 145 mg/day of TriCor (fenofibrate) for 10 days and continuously monitored for disease progression and outcomes.
The findings were posted 12 August on Research Square and are currently under peer-review.
“The results were astounding,” said Nahmias. “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 added.
These results are promising as TriCor (fenofibrate) was approved by the FDA in 1975 for long-term use and has a strong safety record.
“There are no silver bullets,” stressed Nahmias, “but fenofibrate is far safer than other drugs proposed to date, and its mechanism of action makes is less likely to be variant-specific.”
“All patients were discharged within less than a week after the treatment began and were discharged to complete the 10-day treatment at home, with no drug-related adverse events reported,” noted Maayan. “Further, fewer patients reported Covid-19 side effects during their 4-week follow-up appointment,” he added.
The investigators stressed that while the results were extremely promising, only randomized placebo-controlled studies can serve as basis for clinical decisions.
“We entered the second phase of the study and are actively recruiting patients”, explained Nahmias, noting that two Phase 3 studies are already being conducted in running South America, the United States (NCT04517396) and Israel (NCT04661930).
Metabolic Regulation of SARS-CoV-2 Infection. Yaakov Nahmias, et al. Research Square