In severe or critical COVID-19 patients in hospital, addition of the arthritis drug tocilizumab to standard care is not better than the standard care alone in improving the clinical outcomes after 15 days.
The findings of this trial are published in the journal The BMJ
The trial was stopped early as there was an increased number of deaths in patients receiving tocilizumab.
Tocilizumab acts by blocking interleukin 6, a specific part of the immune system that can go into overdrive in some COVID-19 patients. This can help reduce the body's inflammatory response to the virus and avoid some of the more dire consequences of the disease. However, its effects are not well defined.
The researchers conducted a randomized controlled trial and compared tocilizumab plus standard care with standard care alone in patients admitted to hospital with severe or critical COVID-19. For the study, 129 relatively young adults (average age 57 years) with confirmed COVID-19 were selected.
The patients received supplemental oxygen or mechanical ventilation and also had abnormal levels of at least two chemicals linked to inflammation in their blood. Patients were divided into two groups, first group consisted of 65 patients who received tocilizumab plus standard care and 64 received standard care alone.
The patients were monitored for 15 days and other important factors like underlying conditions and the use of other medication, were taken into account. At the end of day 15, 28 percent patients (18 patients) in the tocilizumab group and 20 percent (13 patients) of patients received mechanical ventilation or died.
At the end of day 15, 11 patients died in the tocilizumab group compared to 2 patients in the standard care group. The trial was stopped early due to the safety concerns. In both groups, deaths occurred due respiratory failure or multiple organ dysfunction.
The researchers said, "Tocilizumab plus standard care was not superior to standard care alone in improving clinical status at 15 days and might increase mortality. The results raise questions about an anti-inflammatory approach in the treatment of covid-19 beyond corticosteroids."