Pharma player Roche has announced a range of actions to help combat the Covid-19 pandemic, including the initiation of new clinical trial.
Covid 19
The company has begun work on 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).
The study will evaluate the safety and efficacy of Roche’s immunosuppressive drug Actemra/RoActemra compared to a placebo, in the treatment of patients with severe Covid-19 pneumonia.
The study, COVACTA, will be the first global trial to test the drug in this setting. Roche will also consider data coming from other independent trials involving Actemra.
Whilst Roche has not experienced any major supply issues due to Covid-19, the company is preparing to accelerate its manufacturing capacity in relation to Actemra, in case there is a potential increase in demand for the drug.
As a major diagnostics player, Roche has also received FDA Emergency Use Authorisation for its cobas Sars-Cov-2 Test to detect the virus that causes Covid-19. The test is also available in markets with CE use. Roche has stated it is working to increase access to these critical tests and urges healthcare organisations to focus Covid-19 testing on patients with signs of the disease and not broadly testing the healthy population.
Roche is also calling on governments across the world to work closely with industry to keep manufacturing and supply running, and to help the industry meet demand across the globe. Therefore, the company has called to ensure the free flow of vital goods across national borders to keep manufacturing and supply running; consider pragmatic temporary adjustments to regulations on packaging, reviews, customs etc, to expedite delivery of urgently needed medical supplies, and work together across governments internationally, in order to balance global needs.