On May 28, 2020, Roche announced it had initiated of a global phase III, randomised, double-blind, multicentre study (REMDACTA) to evaluate the safety and efficacy of Actemra/RoActemra plus the investigational antiviral remdesivir, versus placebo plus remdesivir in hospitalised patients with severe COVID-19 pneumonia, in collaboration with Gilead Sciences.

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

In addition to REMDACTA, Roche is close to completing enrolment of the global randomised, double-blind, placebo-controlled phase III clinical trial (COVACTA, NCT04320615) to evaluate the safety and efficacy of intravenous Actemra/RoActemra plus standard of care (SOC), versus placebo plus SOC in hospitalised adult patients with severe COVID-19 pneumonia. The first patient was randomised on April 3. In total, approximately 450 patients will be enrolled in COVACTA. This increase from the original target of 330 patients will allow for even more robust data, while minimally extending the recruitment period. Roche is committed to sharing data from the COVACTA study as soon as possible this summer. In addition, the protocol for COVACTA allows the inclusion of patients who are being treated with antivirals, including investigational antivirals. Data from the REMDACTA trial are designed to supplement the COVACTA study.

The COVACTA study is conducted in collaboration with the US Food & Drug Administration (FDA) and 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). Roche is also a participant in the Accelerated COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, led by the National Institutes of Health (NIH) and the Foundation of the NIH.

Remdesivir has been issued an Emergency Use Authorisation by the US Food & Drug Administration (FDA) for the treatment of hospitalised patients with severe COVID-19. Remdesivir is an investigational antiviral drug that is being studied in multiple ongoing international clinical trials, and the safety and efficacy of remdesivir for the treatment of COVID-19 are not yet established. Remdesivir has not been approved by the US FDA for any use. For information about the authorized use of remdesivir and mandatory requirements of the Emergency Use Authorisation in the US, please review the Fact Sheet for Healthcare Providers and FDA Letter of Authorisation available at www.gilead.com/remdesivir.