Pioneering Phase III Clinical Trial Investigates Multiple Potential Treatments

The trial was designed by researchers at Canada and is aimed at addressing the persisting challenges posed by Long-COVID

Man doing medical research

Prominent contract research organization, Purpose Life Sciences (PLS) is set to launch a groundbreaking Phase III clinical trial in conjunction with Dr. Gilmar Reis of Card Research, an expansive medical clinic network based in Brazil. The trial was designed by researchers at McMaster University in Hamilton, Canada, and is aimed at addressing the persisting challenges posed by Long-COVID. As a multi-center study beginning with 1,500 patients, the trial will rigorously assess the efficacy of multiple potential treatment options – beginning with fluvoxamine and metformin – in alleviating the symptoms associated with Long-COVID.

The study will be run internationally, including medical centers across Brazil. The trial will leverage state-of-the-art data management via an EDC developed by Yonalink, to ensure the highest caliber of data integrity.

Long-COVID, a condition characterized by an array of debilitating symptoms, has continued to affect a significant number of individuals even after the acute phase of the disease has passed. Therapeutic research for both acute and Long-COVID has faced challenges marked by inconsistent methodologies, biases, and flawed results. This study aims to rectify this situation by leveraging a robust study infrastructure, efficient control arm utilization, and streamlined intervention launches. The new approach seeks to swiftly identify effective Long-COVID-19 treatments and assess comparative efficacy without compromising the rigorous standards of a randomized clinical trial.

Metformin, a well-established drug in the treatment of type 2 diabetes, presents an intriguing potential for Long-COVID treatment. While initial clinical trials employing metformin in acute COVID-19 cases did not demonstrate significant efficacy in reducing clinically relevant events or symptoms, recent data suggests that prolonged use and follow-up of patients on metformin may lead to a lower incidence of shortness of breath, fatigue, and nonspecific neurological symptoms. The trial seeks to explore the potential benefit of metformin in Long-COVID cases. Fluvoxamine, a known SSRI and S1R receptor agonist  has shown potential in preliminary tests to reduce excessive inflammation in those with the virus. New information published in Cell reported that researchers studying people with symptoms months after infection had reduced rates of serotonin—a chemical messenger involved in regulating mood and digestion, among myriad other functions—which in turn causes cognitive problems.

“Everyone knows someone affected by COVID-19” says Dr. Edward Mills, Founder of PLS. “It’s a true privilege to be able to spearhead a project that will make a difference for people around the globe. COVID knows no geographic boundaries; it doesn’t differentiate between gender, ethnicity, or socioeconomic status, and finding a solution to such a prevalent disease will have a significant impact on those suffering from Long-COVID and their families.”

PLS and Card Research are committed to delivering meaningful advancements in Long-COVID treatment and to using the most advanced data management tools to ensure that the trial is run with the utmost efficiency and concern for data quality and integrity. The research subject participation period extends up to 90 days, allowing for rigorous data collection and analysis, ensuring that the clinical results are robust and reliable.

For further information, please contact:

Gav Martell

[email protected]

1-888-411-0741

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About PLS (Purpose Life Sciences):

PLS is a leading research organization dedicated to advancing medical science and improving patient outcomes. With a strong commitment to research and innovation, PLS conducts clinical trials and studies aimed at addressing some of the most pressing health challenges of our time.

About Yonalink

YonaLink, with offices in Boston and Tel Aviv, streamlines clinical trial operations globally by seamlessly integrating patient data from Electronic Health Records (EHR) into a real-time Electronic Data Capture (EDC) system. Their full-service data management platform offers EHR-to-EDC capabilities, EDC, eConsent, ePRO/eCOA, and more, into one convenient and easy-to-use platform. Learn more at www.yonalink.com.

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