Off-label use of drugs, known as real-world drug repurposing, provides a critical toolset in the battle against COVID-19.

Key Messages

Real-world drug repurposing - the immediate "off-label" prescription of drugs to address urgent clinical needs - is an indispensable strategy gaining rapid traction in the current COVID-19 crisis.

In urgent public health crises, it is often the only realistic source for finding rapid treatment solutions

To be considered for real-world repurposing, drug candidates should ideally have a track record of safety, affordability, and wide accessibility.

This paper examines the evidence on the potential of fenofibrate in the treatment of COVID-19 patients.

Fenofibrate is a drug used to treat patients with abnormally high levels of triglycerides and LDL cholesterol.

Previous studies have shown fibrates such as fenofibrate and bezafibrate have both cardio-protective and antiviral activities.

Studies also show that fenofibrate has anti-inflammatory effects on the kidneys and retinas by increasing the dilation of their micro blood vessels.

Fibrates also have particularly powerful anti blood-clotting properties; they are able to reduce levels of d-Dimer and fibrinogen, both of which play a role in the abnormal blood clotting seen in COVID-19 patients.

An Israeli pre-clinical study also found that fenofibrate reversed metabolic changes caused by SARS-CoV-2, lowered or blocked viral replication, and reduced COVID-19 progression in lung tissue.

Fenofibrate’s broad spectrum of beneficial effects added to its safety, affordability, and widespread availability, make it a good off-label candidate to effectively treat COVID-19.

JMIRx Med

Publication Date: September 30, 2020
Peer Reviewed: Yes
Publication Type: Original | Theoretical
DOI: https://www.doi.org/10.2196/19583

No Time to Waste: Real-World Repurposing of Generic Drugs as a Multifaceted Strategy Against COVID-19

Moshe Rogosnitzky, Esther Berkowitz, Alejandro R Jadad

Abstract

Real-world drug repurposing-the immediate “off-label” prescribing of drugs to address urgent clinical needs-is an indispensable strategy gaining rapid traction in the current COVID-19 crisis. Although off-label prescribing (ie, for a nonapproved indication) is legal in most countries, it tends to shift the burden of liability and cost to physicians and patients, respectively. Nevertheless, in urgent public health crises, it is often the only realistic source of a meaningful potential solution. To be considered for real-world repurposing, drug candidates should ideally have a track record of safety, affordability, and wide accessibility. Although thousands of such drugs are already available, the absence of a central repository of off-label uses presents a barrier to the immediate identification and selection of the safest, potentially useful interventions. Using the current COVID-19 pandemic as an example, we provide a glimpse at the extensive literature that supports the rationale behind six generic drugs, in four classes, all of which are affordable, supported by decades of safety data, and pleiotropically target the underlying pathophysiology that makes COVID-19 so dangerous. Having previously fast-tracked this paper to publication in summary form, we now expand on why cimetidine/famotidine (histamine type-2 receptor antagonists), dipyridamole (antiplatelet agent), fenofibrate/bezafibrate (cholesterol/triglyceride-lowering agents), and sildenafil (phosphodiesterase-5 inhibitor) are worth considering for patients with COVID-19 based on their antiviral, anti-inflammatory, renoprotective, cardioprotective, and anticoagulation properties. These examples also reveal the unlimited opportunity to future-proof public health by proactively mining, synthesizing, and cataloging the off-label treatment opportunities of thousands of safe, well-established, and affordable generic drugs.