On May 27, Genentech, a member of the Roche Group, announced the initiation of a global, multicenter Phase III clinical study evaluating tocilizumab in combination with remdesivir for the treatment of hospitalized patients with severe COVID-19.
Patient recruitment for this study is expected to commence in June, with a planned enrollment of 450 patients across the United States, Canada, and Europe. The study aims to evaluate the efficacy and safety of tocilizumab plus remdesivir versus placebo plus remdesivir in patients with severe COVID-19, all of whom will also receive standard of care. Patients will be followed for 60 days after randomization. Primary and secondary endpoints include clinical status, mortality, mechanical ventilation, and intensive care unit (ICU) metrics.
Genentech also announced that patient enrollment for its Phase III COVACTA study (NCT04320615), a randomized, double-blind, placebo-controlled trial evaluating tocilizumab in patients with severe COVID-19, is nearing completion, with results expected to be released this summer. The first patient was enrolled on April 3, and approximately 450 patients will ultimately be enrolled. Tocilizumab has not yet been approved in the United States for the treatment of COVID-19.
Currently, Gilead’s remdesivir has received Emergency Use Authorization from the FDA for the treatment of severe COVID-19 and has been formally approved in Japan under the brand name Veklury. The United Kingdom has also issued an Early Access to Medicines Scheme (EAMS) for remdesivir to make it available to patients.