Roche Launches Phase III Trial of Actemra/RoActemra Combination for Severe COVID-19 Pneumonia
Basel, Switzerland – October 26, 2023 – Roche today announced the initiation of a pivotal Phase III clinical trial evaluating the efficacy and safety of Actemra/RoActemra (tocilizumab) in combination with remdesivir for hospitalized patients suffering from severe COVID-19 pneumonia.The global study will enroll approximately 600 patients across multiple countries.
The trial aims to determine if adding Actemra/RoActemra to standard care,including remdesivir,can improve clinical outcomes for patients with critical illness due to COVID-19. COVID-19 continues to pose a significant global health threat, and despite advancements in treatment, a substantial need remains for therapies that can reduce the risk of severe complications and mortality. Actemra/roactemra, an interleukin-6 (IL-6) receptor antagonist, has demonstrated benefit in treating inflammatory conditions, and this trial will investigate its potential to modulate the immune response in severe COVID-19.
The randomized, double-blind, placebo-controlled study will assess the impact of Actemra/RoActemra plus remdesivir on time to clinical advancement, mortality, and other key clinical endpoints. Patients enrolled will be hospitalized with severe COVID-19 pneumonia and require supplemental oxygen.
“We are committed to exploring potential treatment options for COVID-19 and addressing the ongoing medical needs of patients worldwide,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer. “This Phase III trial builds on the existing body of evidence for Actemra/RoActemra and seeks to determine if a combination approach can provide additional benefit to those most severely affected by this disease.”
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