Speaker
Susanna Naggie, MD, MHS
Professor of Medicine
Vice Dean for Clinical Research
Duke University School of Medicine
Keywords
ACTIV, ACTIV-6, COVID-19, Ivermectin, Inhaled Fluticasone
Key Points
- The key clinical questions of the ACTIV-6 study are: how to help someone feel better faster with newly diagnosed mild-moderate COVID-19 and how to prevent hospitalizations or death in someone with newly diagnosed mild-moderate COVID-19?
- ACTIV-6 is testing medication doses approved by the FDA for other purposes, i.e., repurposed drugs. It is a decentralized, fully remote trial, and data are largely patient reported. Participants test positive for COVID-19 with a FDA-authorized test, register from home, are randomized remotely, receive study medication through the central pharmacy, and follow instruction until their clinical symptoms improve. All of the surveys are completed online. The measured outcomes for ACTIV-6 are days of benefit and time to recovery/hospitalization and death.
- ACTIV-6 is actively recruiting across 93 sites with 5,034 randomized. Results have been shared for the Ivermectin-400 and Fluticasone arms. The study has closed the Fluvoxamine-50 and Ivermectin-600 arms.
- There were no differences observed in the relief of mild-to-moderate COVID-19 symptoms between patients taking Ivermectin-400 and the placebo. There were no safety concerns or differences in hospitalization or death.
- There is no evidence that Fluticasone Furoate decreased time spent unwell. There is no observed symptomatic or clinical benefit of this medication of this dose or duration. There is no improvement for time to recover or reduction in hospitalizations. There was some evidence of increased acute care needs (urgent care, emergency room visit) in the fluticasone furoate arm. No safety concerns were identified.
Discussion Themes
–Before anyone was enrolled, which arm did you think would enroll the fastest? Given the history with other repurposed drugs, I was concerned people would not want to take Ivermectin. This was one of the reasons we gave people options about which drugs they were willing to take. It turned out that Ivermectin turned out to be a good recruitment tool.
-What were some early lessons learned in terms of how to reach people given the hybrid nature of the study? The sites had a very clear role, and the training was really important. There was a lot of outreach to sites and they embraced the remote trial. One thing that has been a struggle is the diversity in the population and the equity in access to trials. We did not see as much diversity in this decentralized trial.
-Were there concerns about having patients not associated with a site? For ACTIV-6, if we had not had a call center we would not have gotten the word out as much and participation would not have been as robust.
Learn more about ACTIV-6.
Tags
#pctGR, @Collaboratory1