Speaker
Eric Lenze, MD
Wallace and Lucille K. Renard Professor of Psychiatry & Anesthesiology
Washington University School of Medicine, St. Louis
Topic
Fluvoxamine for Early Treatment of COVID-19: The STOP COVID Clinical Trials
Keywords
COVID-19 treatment; STOP COVID; Fluvoxamine; Repurposed therapy; Decentralized clinical trial
Key Points
- While using Fluvoxamine to treat anxiety in patients with Wolfram Syndrome, Dr. Reiersen from Washington University, St. Louis learned that Fluvoxamine reduced inflammation and interfered with viral function.
- Dr. Lenze, Dr. Reiersen, and Dr. Mattar began the preliminary pragmatic, non-contact, but high-touch STOP COVID trial in April 2020.
- Results from the preliminary study showed that 0% of patients experienced clinical deterioration in the Fluvoxamine group while 8.3% of patients in the placebo group deteriorated.
- The STOP-COVID 2 study was a decentralized, hub-and-spoke clinical trial conducted across the US and 2 provinces of Canada.
- The Data Safety Monitoring Board(DSMB) for the study recommended an early stop for futility due to a low case rate and difficulty recruiting patients.
Discussion Themes
What outcome variables should we be using in COVID-19 studies? A binary outcome measure may limit the power of the study. When possible, continuous outcomes provide more statistical power and come closer to representing real-life outcomes.
What role should primary care providers play in clinical studies?
Read more about Dr. Lenze’s work with the STOP COVID trials.
Tags
#pctGR, @Collaboratory1