Spanning four continents and enrolling hundreds of people, a new clinical trial led by scientists from Western and the Schmidt Initiative for Long Covid (SILC) will test the effectiveness of two anti-inflammatory medicines as potential treatments for long COVID.
"Despite the global prevalence of long COVID, patients report different symptoms and their presentation can be influenced by where they happen to live," said Dr. Douglas Fraser, professor at Western's Schulich School of Medicine & Dentistry. "A study with global reach, tailored to examine each patient's most severe symptoms, has the potential to bring hope to people well beyond Canada and the U.S."
The trial, funded by SILC, will examine whether upadacitinib and pirfenidone - approved for treating arthritis and lung disease, respectively - can be repurposed to reduce or eliminate symptoms of long COVID.
The drugs were identified by an earlier SILC-funded study that, over the past 18 months, examined over 5,400 blood proteins from 1,028 participants with and without long COVID and found 13 common biological pathways for the progression of the disease. Upadacitinib and pirfenidone were identified using artificial intelligence as two existing drugs that could interrupt several of those pathways.
"Drug repurposing has the potential to bring effective treatments to long COVID patients worldwide far more quickly than creating a new medicine from scratch," said Dr. John Redd, CEO of SILC.
"Our hope is that the 65 million people living each day with this often debilitating condition will soon find relief for their symptoms - no matter where in the world they happen to live." - Dr. John Redd, CEO of the Schmidt Initiative for Long Covid
Spanning seven trial locations in the U.S., Canada, Brazil, Italy, Uganda and Zambia, the Phase III, double-blind, placebo-controlled multi-arm platform study will enroll a total of 348 participants. Researchers will track five symptoms - fatigue, breathing issues, memory and thinking problems, muscle and joint aches and circulation - to determine which is most severe in each patient. Researchers will investigate the two drugs versus placebos for the first three months, perform an analysis, and then monitor participants for an additional three months.
The study will progress using an adaptive platform - meaning researchers can pivot to stop testing either of the drugs if they fail to show results or, if both drugs appear promising, stop use of the placebo. The method was notably used to rapidly develop and test COVID therapeutics during Operation Warp Speed, a U.S. effort during the height of the pandemic.
The trial is the second of three set for the first half of 2025 with funding and guidance from SILC, a nonprofit organization founded in 2023 by philanthropists Eric and Wendy Schmidt to advance long COVID care for patients globally.
