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).
Protocol closed with 10 participants enrolled (6 at INCMNSZ & 4 at INER) (https://www.nejm.org/doi/10.1056/NEJMoa2007764)
Protocol closed with 68 participants enrolled (45 at INCMNSZ & 23 at INER) (https://www.nejm.org/doi/full/10.1056/NEJMoa2031994)
Protocol closed with 57 participants enrolled (31 at INCMNSZ & 26 at INER). Database is being completed and cleaned to permit the “Study Data Analysis”.
Protocol amendment Ver 9.0.
Implementation in progress