Tocilizumab Failed to Reduce Mortality in Severe COVID-19 Patients:  Results from a Randomized Controlled Clinical Trial

Mona Talaschian; Maryam Akhtari; Mahdi Mahmoudi; Shayan Mostafaei; Mohamadreza Jafary; Seyyed  Mostafa Jalali; Kourosh Sadeghi; Keivan Gohari Moghadam; Hengameh  Ansari Tadi; Ahmadreza Jamshidi

doi:10.18502/ijaai.v23i1.14956

Mona Talaschian Department of Internal Medicine, School of Medicine, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
Maryam Akhtari Tobacco Prevention and Control Research Center (TPCRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran
Mahdi Mahmoudi Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran
Shayan Mostafaei Department of Biostatistics, School of Health, Kermanshah University of Medical Sciences, Kermanshah, Iran
Mohamadreza Jafary Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
Seyyed Mostafa Jalali Clinical Nutrition and Dietetics Department, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Kourosh Sadeghi Department of Clinical Pharmacy, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
Keivan Gohari Moghadam Pulmonary Ward, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
Hengameh Ansari Tadi Emergency ICU, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
Ahmadreza Jamshidi Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran

DOI: https://doi.org/10.18502/ijaai.v23i1.14956

Keywords: Coronavirus disease 2019 virus; Interleukin-6; Randomized controlled trial; Tocilizumab

Abstract

The severe coronavirus disease 2019 (COVID-19) is associated with increased levels of blood interleukin (IL)-6. Therefore, it is hypothesized that modulating the levels or effects of IL-6 could diminish airway inflammation and alter the course of COVID-19.

We conducted a controlled, randomized, double-blind clinical trial on hospitalized patients with severe COVID-19 in Iran. The patients were randomly distributed by block randomization to take either standard-of-care (SOC) plus 1 or 2 doses of tocilizumab 8 mg/kg or SOC alone. The endpoint was defined by clinical improvement and discharge.

We enrolled 40 patients (20 patients in each group) from 10 July to 10 December 2020. After randomization, 1 patient in the SOC arm and 3 patients in the tocilizumab arm refused to participate and were eliminated from the study.

The mean age of participants was 59.62±15.80 in the tocilizumab group (8 women and 9 men)

and 63.52±12.83 years old in the SOC group (9 women and 10 men) groups. The number of patients

who recovered did not differ significantly between the tocilizumab and SOC groups (12 [70.6%][70.6%] vs. 15 [78.9%]), respectively). Hospitalization rates were also similar between the groups (Log-rank test, p=0.615; hazard ratio, 0.83; 95% C‎‎I [0.‎39–1.78]). The results show that tocilizumab could not be a beneficial agent for treating severe cases of COVID-19 patients and would not significantly improve clinical outcomes.