Treating severe COVID-19 patients with the arthritis drug tocilizumab along with standard care is no better than standard care alone in improving clinical outcomes at 15 days, says the results of a trial which was stopped early due to increased number of deaths among those receiving the drug. The findings, published in the peer-reviewed journal The BMJ, noted that there was an increased number of deaths at 15 days in severe COVID-19 patients receiving tocilizumab contradicting earlier observational studies suggesting a benefit of the drug. However, the scientists, including those from Universidade Federal de Sao Paulo in Brazil, said these contradictory effects need to be assessed in future studies.
They explained that the drug blocks a specific part of the immune system — interleukin 6 that can go into overdrive in some COVID-19 patients. While tocilizumab was thought to help lessen the body’s inflammatory response to the virus and avert dire consequences of the disease, the study said the drug’s effects are not well defined.
In the research, the scientists conducted a clinical trial comparing tocilizumab plus standard care with standard care alone in patients admitted to hospital with severe or critical COVID-19. Their findings are based on 129 adults (average age of 57 years) with confirmed COVID-19 at nine hospitals in Brazil between 8 May and 17 July 2020.
The patients received supplemental oxygen or mechanical ventilation and had abnormal levels of at least two molecules linked to inflammation in their blood. They were randomly divided into two groups, 65 who received tocilizumab plus standard care, and 64 who received standard care alone.
Other factors, such as underlying conditions and use of other medication, were taken into account and all patients were monitored for 15 days, the study noted. the scientists said 18 patients in the tocilizumab group and 13 in the standard care group were receiving mechanical ventilation or died.
They said death at 15 days occurred in 11 patients in the tocilizumab group compared with two in the standard care group. Since the increased number of deaths in the tocilizumab group raised safety concerns, the trial was stopped early, the researchers added. In both groups, they said deaths were attributed to COVID-19 related to acute respiratory failure or multiple organ dysfunction.
Citing the limitations of the study, the researchers said the sample size of the trial was small, which could affect the chances of detecting a true effect. However, they added that the results were consistent after adjusting for levels of respiratory support needed by patients at the start of the trial. The researchers concluded that in patients with severe or critical COVID-19, “tocilizumab plus standard care was not superior to standard care alone in improving clinical status at 15 days and might increase mortality.”.