Adaptive COVID-19 Treatment Trial (ACTT)

This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19.

The study is a multicenter trial that will be conducted in up to approximately 100 sites globally.

The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s).

ACTT-1 (Remdesivir vs Placebo)

Protocol closed with 10 participants enrolled (6 at INCMNSZ & 4 at INER) (https://www.nejm.org/doi/10.1056/NEJMoa2007764)

ACTT-2 (Baricitinib tablets + Remdesivir IV vs Placebo tablets + Remdesivir IV)

Protocol closed with 68 participants enrolled (45 at INCMNSZ & 23 at INER) (https://www.nejm.org/doi/full/10.1056/NEJMoa2031994)

ACTT-3 (Interferon beta-1a SQ injection + Remdesivir IV vs Placebo SQ injection + Remdesivir IV)

Protocol closed with 57 participants enrolled (31 at INCMNSZ & 26 at INER). Database is being completed and cleaned to permit the “Study Data Analysis”.

ACTT-4 (Baricitinib/Remdesivir vs Dexamethasone/Remdesivir)

Protocol amendment Ver 9.0.

Implementation in progress