Global Clinical Trial Launches to Test Sipavibart as Potential Long COVID Treatment
Key Insights
Nova Southeastern University researchers have begun a clinical trial testing AstraZeneca's monoclonal antibody sipavibart as a potential treatment for Long COVID (search), funded by the Schmidt Initiative for Long COVID (search).
The double-blind, randomized controlled trial will enroll 100 patients to evaluate whether sipavibart, already approved for COVID-19 prevention in Japan and the EU, can improve cognitive dysfunction, autonomic nervous system effects, and exercise tolerance.
This trial is one of three Long COVID (search) treatment studies launching in 2025, alongside another global study testing anti-inflammatory drugs upadacitinib and pirfenidone across seven locations on four continents.
Nova Southeastern University (NSU) researchers have launched a clinical trial to evaluate sipavibart, AstraZeneca's long-acting monoclonal antibody, as a potential treatment for Long COVID (search). The study, funded by the Schmidt Initiative for Long COVID (search) (SILC), aims to determine if the antibody can alleviate persistent symptoms affecting millions worldwide.
Dr. Nancy Klimas, Director of the Institute for Neuro-Immune Medicine at NSU, is leading the multi-year study that will enroll 100 patients suffering from Long COVID (search). "Like many multi-symptom, post-viral conditions, Long COVID is incredibly complicated and thus little understood. Finding a treatment will be life-changing for patients suffering from the myriad symptoms of Long COVID," said Dr. Klimas.
Trial Design and Methodology
The double-blind, randomized controlled trial will divide participants into two equal groups receiving either sipavibart or a placebo. Sipavibart, which targets the distinctive spike proteins (search) of the SARS-CoV-2 virus, is already approved for pre-exposure prophylaxis of COVID-19 in Japan and the European Union.
Researchers will evaluate patients quarterly, focusing on improvements in several key Long COVID (search) symptoms:
- Cognitive dysfunction (attention lapses, concentration difficulties, slowed reaction time)
- Heart rate and blood pressure dysregulation
- Autonomic nervous system effects
- Exercise tolerance
The study will also test for lingering viral spike proteins (search) in patients' plasma and stool samples, while creating a repository of blood and other specimens for further research.
The Inspiration Behind the Trial
The trial was inspired by a 2024 study published in the American Journal of Emergency Medicine, which reported that some patients' Long COVID (search) symptoms disappeared after receiving monoclonal antibodies for acute COVID-19. Dr. John Redd, CEO of SILC and former leader in the U.S. Department of Health and Human Services' pandemic response, connected with the study authors to organize this collaboration.
"Long COVID (search) affects at least 65 million people worldwide, and with more than 200 symptoms, the health impacts of the disease can be debilitating," explained Dr. Redd. "SILC is dedicated to eliminating Long COVID worldwide, especially in under-resourced countries and communities."
Broader Research Initiatives
This sipavibart trial is one of three Long COVID (search) treatment studies expected to begin in 2025 with SILC funding. Another significant initiative is a global clinical trial testing two anti-inflammatory medications—upadacitinib and pirfenidone—as potential Long COVID treatments.
The global study, led by researchers from Western University in collaboration with SILC, will span seven locations across four continents, enrolling 348 participants. This Phase III trial will examine whether these drugs, currently approved for arthritis and lung disease respectively, can be repurposed to address Long COVID (search) symptoms.
Dr. Douglas D. Fraser, Professor at Western University's Schulich School of Medicine & Dentistry, emphasized the importance of the global approach: "Despite the global prevalence of Long COVID (search), patients report different symptoms and their presentation can be influenced by where they happen to live. A study with global reach has the potential to bring hope to people well beyond Canada and the U.S."
Drug Repurposing Strategy
The selection of upadacitinib and pirfenidone resulted from an earlier SILC-funded study that analyzed over 5,400 blood proteins from more than 1,000 participants. This research identified 13 common biological pathways in Long COVID (search) progression, and artificial intelligence analysis suggested these existing drugs could interrupt several of those pathways.
"Drug repurposing has the potential to bring effective treatments to Long COVID (search) patients worldwide far more quickly than creating a new medicine from scratch," noted Dr. Redd.
Institutional Support
NSU, Florida's largest private research university with an R1 designation from the Carnegie Foundation, brings significant research expertise to the sipavibart trial. Dr. Ken Dawson-Scully, NSU's senior vice president for research and associate provost, highlighted the institution's commitment: "This trial represents our overall commitment to addressing the most pressing health challenges of our time. By collaborating with the Schmidt Initiative for Long COVID (search), we're leveraging our research expertise to potentially transform treatment options for millions suffering from Long COVID (search)."
The Schmidt Initiative for Long COVID (search), founded in 2023 by philanthropists Eric and Wendy Schmidt, continues to advance global Long COVID (search) care through strategic research funding and collaborative initiatives targeting this persistent post-viral condition.