24-Mar-2020 - F. Hoffmann-La Roche AG

Roche initiates Phase III clinical trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 pneumonia

Roche announced that it are working with the Food & Drug Administration (FDA) to initiate a randomised, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), a part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response (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.

"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," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “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.”

To date, there are several independent clinical trials exploring the efficacy and safety of Actemra/RoActemra for the treatment of patients with 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.

However, this new trial is vital because there are no well-controlled studies and limited published evidence on the safety or efficacy of Actemra/RoActemra in the treatment of patients suffering from COVID-19. In addition, Actemra/RoActemra is not currently approved for this use by any health authorities, including the US Food and Drug Administration (FDA).

In addition to initiating this trial, Roche received FDA Emergency Use Authorisation for the cobas® SARS-CoV-2 Test on March 13, 2020, to detect the novel virus that causes COVID-19 disease.

Facts, background information, dossiers
More about Roche
  • News

    Roche acquires Stratos Genomics

    Roche announced that it has acquired Stratos Genomics, an early-stage sequencing technology company to advance the development of Roche’s nanopore sequencer. The acquisition provides Roche access to Stratos Genomics unique chemistry, Sequencing by Expansion (SBX™). The Roche nanopore sequen ... more

    Roche’s cobas SARS-CoV-2 Test to detect novel coronavirus receives FDA Emergency Use Authorization

    Roche announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the cobas® SARS-CoV-2 Test. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab sampl ... more

    Preventing tumour metastasis

    When cancer cells spread in the body, secondary tumours, called metastases, can develop. These are responsible for around 90 percent of deaths in cancer patients. An important pathway for spreading the cancer cells is through the lymphatic system, which, like the system of blood vessels, ru ... more

  • Companies

    Roche Deutschland Holding GmbH

    more

    Roche Austria GmbH

    Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche i ... more