Swiss drug maker Roche on July 29 announced that its drug Actemra (Tocilizumab), which has emerged as a widely prescribed drug for treating hosiptalised COVID-19 patients, didn't meet its primary endpoint of improved clinical status in hospitalised adult patients with severe COVID-19 associated pneumonia. In addition, the key secondary endpoint of reduced patient mortality at week four, was also not met.
However, Roche said there was a positive trend in time to hospital discharge in patients treated with Actemra. The median time to discharge or ‘ready to discharge’ for Actemra was 20 days and for placebo was 28 days.
The COVACTA study did not identify any new safety signals for Actemra.
Further analysis of the trial results is needed to fully understand the data.
The results will be submitted for publication in a peer-reviewed journal.
“People around the world are waiting for further effective treatment options for COVID-19 and we are disappointed that COVACTA did not demonstrate a benefit for patients in either clinical status or
mortality at week four," said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development.
"We will continue to generate evidence to provide a more complete
understanding of Actemra/RoActemra in COVID-19 associated pneumonia,” Garraway added.
The COVACTA trial was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services.
COVACTA evaluated the safety and efficacy of intravenous Actemra added to standard-of-care treatment compared to treatment with placebo plus standard of care.
The primary endpoint of clinical status in hospitalised adult patients with severe COVID-19 associated pneumonia was measured by a 7-category ordinal scale, which tracked patients’ clinical status based on the need for intensive care and/or ventilator use, as well as supplemental oxygen requirements.
The COVACTA trial is the first global, randomised, double-blind, placebo-controlled phase III study to investigate Actemra in adult patients hospitalised with severe COVID-19 associated pneumonia, with
study locations in the US, Canada and Europe.
Tocilizumab is anti-IL-6 receptor, that works as immunomodulator, is used in treating patients with autoimmune disorders like rheumatoid arthritis, has found to have some potential to control immune system going berserk in certain COVID-19 patients.
In India, the government protocol says Tocilizumab may be considered in patients with moderate disease with progressively increasing oxygen requirements and in mechanically ventilated patients not improving despite use of steroids.
The drug which has to be taken in two doses, is marketed by Roche and its partner Cipla