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    • Roche begins Phase III...

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

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2020-03-20T10:00:00+05:30  |  Updated On 20 March 2020 10:00 AM IST
    Roche begins Phase III clinical trial of Actemra in hospitalised patients with severe COVID-19 pneumonia

    Basel: Roche has announced that it is 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. Learn more here.

    Read also: Roche Gets USFDA Emergency Use Authorization For Its Cobas SARS-CoV-2 Test

    rochefdabiomedical-advanced-research-and-development-authoritybardaactemracovid-19coronavirus

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Medical Dialogues Bureau
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      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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