Speaker
Adit Ginde, MD, MPH
Professor and Vice Chair for Research, Department of Emergency Medicine
Director of Clinical Research, Department of Anesthesiology
Director, Colorado CTSI Trial Innovation Network Hub
University of Colorado School of Medicine
Topic
Taking Research to the Participant: Experiences with TREAT NOW, a No-Touch COVID-19 Trial
Keywords
COVID-19; No-touch trial design; Antiviral therapy; Adaptive platform trial; Repurposed drugs; Patient-reported outcomes
Key Points
- The TREAT NOW trial evaluated the effectiveness and safety of early treatment with antiviral agents (lopinavir/ritonavir) in outpatient adults with COVID-19 for preventing hospitalization and improving clinical outcomes.
- The trial used an adaptive platform approach with the ability to add or remove agents, and focused on repurposed FDA-approved therapies that are rapidly scalable and easily deployed.
- The no-touch design required that the entire trial be completed without having any physical interaction with the participant.
- TREAT NOW shows that no-touch trials are not only feasible but also effective. However, considerable effort was needed to get the smart data systems right. The data system must accommodate many different levels of technical skill, different languages, and different modes of communication.
Discussion Themes
What is the role of a site in a no-touch trial?
What was the most effective recruitment strategy?
What is the demographic breakdown of your participants?
Read more about the TREAT NOW trial on ClinicalTrials.gov.
Tags
#pctGR, @Collaboratory1