Roche – initiates Phase III clinical trial of Actemra/RoActemra with COVID-19 pneumonia
Basel, 19 March 2020-
Roche (SIX: RO, ROG; OTCQX: RHHBY)
today announced we are working with FDA to initiate a randomised, double-blind, placebo-controlled Phase III clinical trial in collaboration with the BARDA), a part of the US Health and Human Services Office of the ASPR, to evaluate the safety and efficacy of
Actemra®/RoActemra® (tocilizumab) plus standard of care in hospitalised 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 soon as possible in early April with a target of approximately 330 patients globally, including the US.
The primary and secondary endpoints include clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables.
Actemra/RoActemra
is part of a co-development agreement with Chugai Pharmaceutical Co., Ltd
and has been approved in Japan since April 2005.
Actemra/RoActemra is approved in more than 110 countries worldwide.
https://www.roche.com/media/releases/med-cor-2020-03-19.htm
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