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Washington, May 3:
In a significant move to address the ongoing health crisis posed by Long Covid, US scientists have initiated a clinical trial to test the effectiveness of the long-acting monoclonal antibody, sipavibart, as a potential treatment for the condition. This trial, spearheaded by researchers at Nova Southeastern University (NSU) in Florida in partnership with the Schmidt Initiative for Long Covid (SILC), aims to bring relief to millions suffering from persistent symptoms following SARS-CoV-2 infection.
The multi-year study, which received clearance from the US Food and Drug Administration (FDA) earlier this year, has enrolled 100 patients who continue to experience a range of symptoms such as fatigue, cognitive impairment, shortness of breath, and cardiovascular issues long after recovering from acute Covid-19. The trial is designed as a double-blind, randomized, and controlled study, with participants receiving either sipavibart or a placebo. Patients will be evaluated every three months for improvements in symptoms, including cognitive dysfunction and autonomic nervous system effects.
Dr. Nancy Klimas, director of NSU’s Institute for Neuro-Immune Medicine and lead investigator, emphasized the complexity of Long Covid, stating, “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”.
Sipavibart, developed by AstraZeneca, has already been approved for the prevention of Covid-19 in Japan and the European Union. Its use in this trial marks one of three major Long Covid treatment studies expected to launch in 2025, reflecting a broader push to find effective therapies for the estimated 65 million people globally affected by the condition.
Dr. John Redd, CEO of SILC, highlighted the global impact of Long Covid, noting, “Long Covid affects at least 65 million people worldwide, and with more than 200 symptoms, the health impacts of the disease can be debilitating”.
Dr. Ken Dawson-Scully, NSU’s Senior Vice President for Research, added, “This trial represents our overall commitment to addressing the most pressing health challenges of our time. We’re leveraging our research expertise to potentially transform treatment options for millions suffering from Long Covid, advance knowledge, and improve patient outcomes”.
The study builds on previous findings that monoclonal antibody treatments may alleviate persistent symptoms in some patients, and will also create a repository of blood and other specimens for further research.
Disclaimer
Sipavibart is currently an investigational treatment for Long Covid and has not yet been approved for this indication in the United States. The clinical trial is ongoing, and its safety and efficacy for Long Covid are yet to be determined. Individuals should consult healthcare professionals before considering any new or experimental therapies.
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