A clinical trial is underway to assess the effectiveness and safety of sipavibart, AstraZeneca's long-acting monoclonal antibody designed to provide protection against Covid-19, as a potential treatment for Long Covid, the Nova Southeastern University (NSU) and the Schmidt Initiative for Long Covid (SILC) announced today.
With funding from SILC, NSU researchers led by Dr. Nancy Klimas are enrolling 100 patients in the multi-year study with the goal of improving their Long Covid symptoms and restoring them to full health.
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."
Dr. Nancy Klimas, Director, Institute for Neuro-lmmune Medicine at NSU
The study will test whether the monoclonal antibody sipavibart, which is approved for the pre-exposure prophylaxis (prevention) of COVID-19 in Japan and the EU, is effective in treating Long Covid. The trial, which the FDA reviewed and cleared for the study earlier this year, is one of three Long Covid treatment trials expected to begin in 2025 that have been initiated and funded by SILC, a nonprofit organization founded in 2023 by philanthropists Eric and Wendy Schmidt to advance Long Covid care for patients globally.
"Long Covid affects at least 65 million people worldwide, and with more than 200 symptoms, the health impacts of the disease can be debilitating," said Dr. John Redd, CEO of SILC. "SILC is dedicated to eliminating Long Covid worldwide, especially in under-resourced countries and communities, by bringing together practitioners to treat patients and by funding research such as monoclonal antibodies and repurposing existing drugs."
Said Dr. Ken Dawson-Scully, NSU's senior vice president for research and associate provost, "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, we're leveraging our research expertise to potentially transform treatment options for millions suffering from Long Covid, advance knowledge, and improve patient outcomes through innovative clinical research."
At the height of the pandemic, Florida was the national leader in utilizing monoclonal antibodies to treat patients who had been diagnosed with COVID, administering more than 200,000 doses throughout the state. In 2024, researchers from the state published a study in the American Journal of Emergency Medicine detailing how a small group of these patients' Long COVID symptoms disappeared after they received the monoclonal antibodies to prevent or treat acute episodes of the virus. When Redd-who was a leader of the U.S. Department of Health and Human Services' response to the virus and helped distribute the antibody therapeutics to Florida years earlier-came across the study, he contacted the authors to organize a collaboration, leading to this trial.
In the double-blind, randomized and controlled trial, researchers will divide patients into two evenly split groups to receive infusions of either a placebo or sipavibart, which targets the unique spike proteins of the Covid virus. Patients will be evaluated every three months for improvement in Long Covid symptoms including cognitive dysfunction-lapses in attention, concentration or reaction time-heart rate or blood pressure dysregulation and other autonomic nervous system effects, and tolerance for exercise. Researchers will also test for any lingering spike proteins in patients, including potentially in plasma and stool samples, and create a repository of blood and other specimens for further study.
NSU, Florida's largest private research university, is an R1 institution-an elite designation given by the Carnegie Foundation to universities reaching the highest levels of research activity, funding, and doctoral degrees awarded.
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