03.19.20
Roche is working with the FDA to initiate a randomized, double-blind, placebo-controlled Phase III trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), to evaluate the safety and efficacy of Actemra/RoActemra (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care.
This is the first global study of Actemra/RoActemra in this setting and is expected to begin enrolling as early as April in 330 patients globally, including the U.S. The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables.
There are currently several independent clinical trials exploring the efficacy and safety of Actemra/RoActemra for the treatment of COVID-19 pneumonia.
Actemra/RoActemra has been included in the 7th updated diagnosis and treatment plan for COVID-19 issued by China’s National Health Commission (NHC) on March 3, 2020.
Additionally, Roche received FDA Emergency Use Authorization and began shipping its cobas SARS-CoV-2 Test on March 13 to detect the novel virus that causes COVID-19 disease. Learn more here.
This is the first global study of Actemra/RoActemra in this setting and is expected to begin enrolling as early as April in 330 patients globally, including the U.S. The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables.
There are currently several independent clinical trials exploring the efficacy and safety of Actemra/RoActemra for the treatment of COVID-19 pneumonia.
Actemra/RoActemra has been included in the 7th updated diagnosis and treatment plan for COVID-19 issued by China’s National Health Commission (NHC) on March 3, 2020.
Additionally, Roche received FDA Emergency Use Authorization and began shipping its cobas SARS-CoV-2 Test on March 13 to detect the novel virus that causes COVID-19 disease. Learn more here.
