The study will assess the safety and efficacy of Actemra in combination with standard of care compared to placebo
Roche has entered into a partnership with the US Food & Drug Administration (FDA) to commence a phase III clinical trial of Actemra/RoActemra (tocilizumab) in hospitalised patients with severe COVID-19 pneumonia.
Actemra/RoActemra is said to be the first approved anti-IL-6 receptor biologic to treat moderate-to-severe active rheumatoid arthritis (RA) in adult patients.
The randomised, double-blind, placebo-controlled Phase III trial will be conducted in collaboration with the US Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA).
The study will assess the safety and efficacy of Actemra/RoActemra in combination with standard of care compared to placebo.
Actemra Phase III trial will enrol 330 patients globally
The Phase III trial is claimed to be the first global study in this setting and will recruit nearly 330 patients worldwide, including in the US. Enrolment is expected to begin in early April.
The primary and secondary endpoints comprise of clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables.
Roche chief medical officer and global product development head: “We are initiating a clinical trial to study Actemra/RoActemra for the treatment of people hospitalised with COVID-19 pneumonia, so that we can better establish the potential role for Actemra/RoActemra in fighting this disease.
“In these unprecedented times, today’s announcement is an important example of how industry and regulators can collaborate quickly to address the COVID-19 pandemic, and we will share the results as soon as possible.”
Roche stated that the patients will be followed for 60 days post-randomisation, and an interim analysis will be carried to look for early evidence of efficacy.
The company added that multiple independent studies are being carried out to assess the drug in patients with Covid-19 pneumonia.
The Actemra/RoActemra was included in the seventh updated diagnosis and treatment plan for COVID-19 issued by China’s National Health Commission (NHC), said Roche.
The new trial is considered important due to lack of well-controlled studies and availability of limited published evidence regarding the drug’s safety and efficacy in Covid-19 patients.
Recently, Roche has obtained the US FDA approval of CINtec PLUS Cytology test for women tested positive for the human papillomavirus (HPV) using its Cobas 4800 HPV test.