Genentech announced the US FDA has approved clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to evaluate the safety and efficacy of intravenous tocilizumab (Actemra) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia.
Genentech is initiating a randomised, double-blind, placebo-controlled phase III study (COVACTA) to evaluate the safety and efficacy of intravenous tocilizumab added to standard of
care in adult patients hospitalised
with severe COVID-19 pneumonia compared to placebo plus standard
Patients will be followed for 60 days post-randomization, and an interim analysis will be conducted to look for early evidence of efficacy.
Tocilizumab was the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).