Objectives: Does Tocilizumab improved survival outcome in SARs-CoV-2 (COVID-19) Acute Respiratory Distress Syndrome patients?
Setting: Retrospective study was carried out in ICU and on floor patients at a secondary level hospital located in the Hudson Valley, New York,
epicenter of Coronavirus pandemic.
Participants: 94 patients with COVID-19 Acute Respiratory Distress Syndrome (ARDS) were included in the study; 22 females and 72 males, at least
18 years old, with confirmed COVID-19 infection, admitted to the hospital between Mar 15, 2020 to Apr 20, 2020.
Interventions: Primary intervention included the administration of IV Tocilizumab 400 mg one-time dose amongst the study group. Primary and Secondary Outcome Measures: We evaluated both the Tocilizumab and control group for survival as primary outcome. HS score, inflammatory markers, length of stay as secondary outcomes were also compared.
Background: The novel human coronavirus, severe acute respiratory syndrome coronavirus-2 (SARs-CoV-2), was declared a global pandemic by the World Health Organization on March 11, 2020 [1]. Hence, there is an urgency to find effective treatment. Of those patients afflicted in the United States, many have required treatment with ventilator secondary to ARDS. Data are needed regarding the benefit of treatment and prevention of the cytokine storms in COVID-19 patients with Tocilizumab.
Methods: We obtained data form patients admitted to Orange Regional Medical Center, (not for profit 383 bed hospital in the Hudson Valley, NY) with confirmed COVID-19 from Mar 15, 2020 to Apr 20, 2020 were identified through electronic health record chart review. We conducted a retrospective, single center study in confirmed COVID 19 positive patients with ARDS requiring mechanical ventilation and compared outcomes amongst those who received Tocilizumab as treatment modality opposed to those that did not.
Results: A total of 94 patients with COVID-19 ARDS were analyzed. 44 were in the study group and 50 in the control group. Average HS score was 114 in the Tocilizumab group and 92 in the control group, difference was statistically significant with P<0.0001. Also, the patients in the study group had elevated levels of IL-6, triglycerides, AST, ferritin which were statistically significant with p < 0.0001 when compared to the control group. Length of stay was longer, average 17.9 days in the Tocilizumab. The overall survival rate was 61.3% in patients who received Tocilizumab compared to 48% in the control group; p =0.1984. The number needed to treat (NNT) was 7.48, if we treat eight patients with Tocilizumab, one will survive.
Conclusions: Cytokine Release Syndrome (CRS) occurs in a large number of patients with severe COVID-19, which is also an important cause of death. IL- 6 is the key molecule of CRS, so IL-6R antagonist Tocilizumab may be of value in improving outcomes. In our study Tocilizumab group seemed to have increased survival outcome but result was not statistically significant. Results have to be interpreted with caution since this is a retrospective study and mortality is affected by multiple, confounding factors.
Author(s): Nafisa Wadud, Naim Ahmed, Mannu Shergill, Maida Khan, Murali Krishna, Aamir Gilani, Samer El Zarif, Jodi Galaydick, Karthika Linga, Shravan Koor, Julia Galea, Lauren Stuczynski, Maria B Osundele