This study was approved by the Institutional Review Board of Hospital Corporation of America (HCA) Healthcare (Nashville, TN, USA) in October 2021. It is a large, retrospective cohort study of 5638 adult patients aged 18 years and older, with severe COVID-19 infection admitted to 16 HCA hospitals in the Houston area of Texas from 1 May 2021 to 30 September 2021 and who received either SOC or SOC plus at least one dose of baricitinib or tocilizumab. No patient was treated with both baricitinib and tocilizumab. The treatment protocol is standardized in all 186 HCA Healthcare hospitals across the United States. As per the hospital policy, all admitted patients were tested for COVID-19 via polymerase chain reaction (PCR). Treatment protocols were standardized and updated by the infectious disease clinical service corporate panel, based on available guidelines.
Tocilizumab or baricitinib can be considered for patients receiving dexamethasone and/or remdesivir with rapidly increasing oxygen needs (via conventional oxygen or HFNC or NIV or invasive oxygenation) and systemic inflammation. Tocilizumab was administered as a single weight-based dose intravenously infused over one hour and baricitinib was administered orally once daily for fourteen days or until hospital discharge, whichever came earlier. These agents were avoided in patients with known active tuberculosis or hepatic diseases (i.e., hepatitis B or C), pregnancy, or chronic immune-suppressing conditions. Tocilizumab was not used in patients with an active or high risk of bowel perforation including complicated diverticulitis. Table 1 describes the dosing criteria for tocilizumab based on the actual body weight of the patients and for baricitinib based on the patient’s renal function per corporate protocol. Pharmacists were authorized to monitor daily, adjust baricitinib dosage based on renal function, and hold therapy based on the laboratory criteria, as described in Table 1.
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