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The National Institute of Allergy and Infectious Diseases Decision to Stop the Adaptive COVID-19 Trial

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O n April 29, the National Institute of Health disclosed the preliminary findings of the ACTT-1 (Adaptive COVID-19 Treatment Trial) (NCT04280705), the first clinical trial in the United States to… Click to show full abstract

O n April 29, the National Institute of Health disclosed the preliminary findings of the ACTT-1 (Adaptive COVID-19 Treatment Trial) (NCT04280705), the first clinical trial in the United States to evaluate an experimental treatment for coronavirus disease-2019 (COVID-19). ACTT was designed as an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of remdesivir (and eventually other drugs) in hospitalized adults diagnosed with COVID-19. Remdesivir is a nucleoside analog that interferes with the action of viral ribonucleic acid–dependent ribonucleic acid polymerase (1). Patients with COVID-19 were randomized to receive remdesivir or placebo as an inpatient and assessed for up to 29 days as an outpatient. The primary outcome variable was time to recovery by day 29. An independent data and safety monitoring board (DSMB) met on April 27 to review data and shared their interim analysis with the ACTT-1 study team. The DSMB noted that when compared with placebo, remdesivirtreated patients had a shorter time to recovery, which is an endpoint that is used frequently in influenza

Keywords: national institute; trial; adaptive covid; covid; institute allergy

Journal Title: JACC: Basic to Translational Science
Year Published: 2020

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