Speaker
Davey Smith, MD
Protocol Co-Chair ACTIV-2
Professor of Medicine, UC San Diego
Topic
Got anything for this cough? Outpatient Treatment Trials in the Time of COVID
Keywords
COVID-19 treatment; Adaptive Platform Trial; ACTIV-2 Trial; Antiviral therapy
Key Points
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An Adaptive Platform Trial is a trial in which multiple drugs can be tested at the same time to increase efficiency and transition seamlessly from a Phase II to a Phase III trial.
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An interim analysis determines if a drug is moved on to trial Phase III.
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The trials adapt as researchers learn more about COVID-19 and potential treatments.
- Monoclonal antibody therapies showed promise initially, but COVID-19 variants have lessened their efficacy.
Discussion Themes
The ACTIV-2 trial initially focused on using antivirals, specifically monoclonal antibodies, to achieve a reduced viral load as an endpoint measure. Changes were made to this endpoint measure as it became clear that the FDA would issue an Emergency Use Authorization only for a decrease in hospitalization and death.
To adjust to the rapidly changing COVID-19 landscape of changing therapeutics, vaccines, and variants, the ACTIV-2 team remained nimble and flexible with the ability to act quickly when presented with new situations and information.
Read more about the Active-2 Trial.
Tags
#pctGR, @Collaboratory1, @DaveySmithMD