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Roche Launches Remdesivir Plus Actemra Trial In COVID-19 Pneumonia

Rochehas begun a Phase III of its Actemra/RoActemra (tocilizumab) in combination with Gilead’s remdesivir as a potential treatment for hospitalized patients with severe COVID-19 pneumonia.

The combination trial is being launched in collaboration with Gilead Sciences Inc., and could help save lives of the most severely ill COVID-19 patients, for whom remdesivir has not shown to have benefits.

The study builds on Roche's ongoing Phase III trial of RoActemra/Actemra, called COVACTA, which is being conducted in collaboration with the US Food and Drug Administration and the Biomedical Advanced Research and Development Authority (BARDA). It assesses the IL-6 antibody anti-inflammatory therapy plus standard of care versus placebo and standard of care with COVID-19 patients hospitalized with pneumonia.

Gilead’s antiviral remdesivir gained emergency use authorization from the FDA at the beginning of May, and similar approval in Japan for hospitalized patients, with data showing it can help reduce hospital stays on average from 15 days to 11 days, but hasn’t shown any impact on mortality rates from the disease.

The new trial, REMDACTA, will compare Actemra/RoActemra plus remdesivir versus placebo plus remdesivir in hospitalized patients with severe COVID-19 pneumonia.

The primary and secondary endpoints include clinical status, mortality, mechanical ventilation, and intensive care variables. Patients will be followed for 60 days post-randomization.





Levi Garraway, Roche’s chief medical officer and head of global product development said, "Based on our current understanding, we believe that combining an antiviral with an immune modulator could potentially be an effective approach to treating patients with severe disease. We're pleased to partner with Gilead to determine whether combining these medicines could potentially help more patients during this pandemic.”

The study is expected to begin enrolling in June with a target of around 450 patients globally, including the US, Canada and Europe.

Roche says it aims to share data from the COVACTA study "as soon as possible this summer." The protocol for COVACTA allows the inclusion of patients who are being treated with antivirals, including investigational antivirals, but Roche decided to set up a dedicated remdesivir plus tocilizumab study to supplement COVACTA after Gilead's drug emerged as the new standard of care for these patients. 

The new trial follows close behind a similar large-scale trial, ACTT2. This is being led by the US National Institute of Allergies and Infectious Diseases (NIAID), and is studying remdesivir in combination with Eli Lilly and Incyte’s JAK inhibitor Olumiant (baracitinib). (Also see "NIH Pushes Ahead With First COVID-19 Combo: Remdesivir Plus Lilly’s Olumiant" - Scrip, 12 May, 2020.)

GSK Aims To Produce 1bn Doses of Pandemic Vaccine Adjuvant

GlaxoSmithKline PLC has confirmed its plans to manufacture 1 billion doses of its pandemic vaccine adjuvant system in 2021 to support the development of multiple adjuvanted COVID-19 vaccine candidates.

The most notable of these are vaccine collaborations with China's Clover Biopharmaceuticals, announced in February, and with Sanofi, which was unveiled in April.

As GSK and Sanofi represent two of the world's biggest vaccine manufacturers, with formidable expertise in vaccines development and global manufacturing capacity, this collaboration is tipped by many as one of the most likely to succeed.

The volume of the UK-based company's forecast output is encouraging – but its 2021 timeline reinforces earlier indications that it and its collaborators will not be among those aiming to have a vaccine ready by the end of 2020.

GSK says its pandemic adjuvant technology could make a significant contribution against COVID-19.  It says this was demonstrated in the last flu pandemic, when its adjuvant helped reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced, contributing to protecting more people. An adjuvant can also potentially enhance the immune response and create a stronger and longer-lasting immunity against infections - a factor which could play a crucial role in any COVID-19 vaccine candidate.

GSK has prioritized its efforts towards making its pandemic adjuvant technology available to partners developing promising COVID-19 vaccine candidates that are suitable for use with an adjuvant. To date, the company has formed several collaborations, including with scientific partners in North America, Europe and China, to develop vaccines.

It says discussions with further potential partners on further collaborations are ongoing.

The firm has unveiled this target after reviewing its global supply network capacity. It has now confirmed that it will manufacture, fill and finish adjuvant for use in COVID-19 vaccines at sites in the UK, US, Canada and Europe.

“We believe that more than one vaccine will be needed to address this global pandemic and we are working with partners around the world to do so," said Roger Connor, President, GSK Global Vaccines.

"We believe that our innovative pandemic adjuvant technology has the potential to help improve the efficacy and scale up of multiple COVID-19 vaccines. With this significant expansion in our manufacturing capacity, we can help deliver up to 1 billion doses of adjuvanted vaccines through 2021, helping protect many more people and support the global effort to fight COVID-19.”

Like other companies racing to develop a COVID-19 vaccine, GSK has started manufacture of the adjuvant at risk, and is in discussions with governments and global institutions about funding for production and supply of the adjuvant.

GSK says it is committed to making its adjuvant available for people across the world, including the world’s poorest countries. This will include donations and collaborations with governments and global institutions that prioritize access.

The company says that it does not expect to profit from sales of its portfolio of collaborations for COVID-19 vaccines – at least during the current pandemic phase. Instead it says it will invest any profits generated back into coronavirus related research and long-term pandemic preparedness, either through GSK’s internal investments, or with external partners.

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