[PubMed] [Google Scholar] 7. BAM/E combination on 27 March 2021. Primary outcome was overall rate of COVID\19 related\hospitalization, including comparison of hospitalization rates between MAB\formulation groups. Secondary outcomes were 30\day mortality and length of stay (LOS). Results and Discussion The population included 643 patients (BAM and BAM/E); median age was 58?years, 43% were male, median BMI was 33?kg/m2, and 24% self\identified as Black. Patients in the BAM/E combination group were significantly younger with higher median BMI and a longer time from symptom onset to infusion. The incidence of 30\day COVID\19 Tetrabenazine (Xenazine) related hospitalization was similar between patients receiving either BAM or BAM/E combination (7.8% and 7.2%, respectively). What Is New and Conclusion This study represents the first such publication of real\world BAM/E hospitalization outcomes. Hospitalization rates utilizing BAM/E were comparable to BAM in our real\world study. test as appropriate. A power calculation was performed for a dichotomous endpoint compared between two independent samples. Sample size required was 432 subjects, assuming alpha 0.05, beta 0.2, and using incidence rates for hospitalization observed in other retrospective real\world MAB studies. 7 , 8 , 9 , 10 The Institutional Review Board approved the study (IRB No. 14630). 3.?RESULTS AND DISCUSSION MAB was administered to 643 patients during the study period (294 received BAM and 349 BAM/E). The characteristics and outcomes of the two groups are shown in Table?1. Patients in the BAM/E cohort were younger, more morbidly obese and had lower rates of diabetes. Other characteristics between groups were similar (Table?1). BAM/E patients had longer median time from symptom onset to infusion (median 6 vs. 4?days, em p /em ? ?0.001). This was driven by a longer time between symptom onset (date patient first noted any symptoms) to referral (date the patient saw a physician who requested MAB infusion) with a median Tetrabenazine (Xenazine) of 3?days for BAM versus 5?days for BAM/E ( em p /em ? ?0.001). Time from symptom onset to test date were similar between groups (median 2 [1C3] days, em p /em ?=?0.837). Time from referral to infusion was similar between groups (median 1?day for both, 0.782). Thirty\day hospitalization rates did not differ between groups (7.8% vs. 7.2%, em p /em ?=?0.751). LOS and 30\day mortality (1% vs. 0.3%, em p /em ?=?0.238) were also similar. TABLE 1 Characteristics and outcomes of COVID\19 patients receiving monoclonal antibody thead valign=”bottom” th align=”left” valign=”bottom” rowspan=”1″ colspan=”1″ Characteristics /th th align=”left” valign=”bottom” rowspan=”1″ colspan=”1″ Total ( em n /em ?=?643) /th th align=”left” Tetrabenazine (Xenazine) valign=”bottom” rowspan=”1″ colspan=”1″ Bamlanivimab ( em n /em ?=?294) /th th align=”left” valign=”bottom” rowspan=”1″ colspan=”1″ Bamlanivimab /etesevimab ( em n /em ?=?349) /th th align=”left” valign=”bottom” rowspan=”1″ colspan=”1″ em p\value /em /th /thead Age Median (IQR)58 (47C66)61 (50C69)55 (45C65) 0.00165?years (%)206 (32.0)112 (38.1)94 (26.9)0.003Male275 (42.8)137 (46.9)138 (39.5)0.086 Self\identified race/ethnicity (%) White411 (63.8)185 (62.9)226 (64.8)0.630Black153 (23.8)68 (23.1)85 (24.4)0.716Middle Eastern30 (4.7)17 (5.8)13 (3.7)0.218Hispanic/Latinx24 (3.7)14 (4.8)10 (2.9)0.206Other15 (2.3)5 (1.7)10 (2.9)0.636Declined10 (1.6)5 (1.7)5 (1.4)0.784 Comorbidities (%) BMI a median (IQR)32.9 (27.6C39)32.2 (27.2C37.2)33.6 (28.3C40.1)0.007BMI 35 (%)261 (41.2)99 (34.6)162 (46.7)0.002BMI 30C40 (%)260 (41.1)120 (42.0)140 (40.3)0.682BMI 40 (%)141 (22.3)49 (17.1)92 (26.5)0.005Cardiovascular disease b 468 (72.8)213 (72.4)255 (73.1)0.861Pulmonary disease c 189 (29.4)94 (32.0)95 (27.2)0.188Immunosuppressed d 136 (21.2)72 (24.5)64 (18.3)0.059Diabetes215 (33.4)110 (37.4)105 (30.1)0.050Chronic kidney disease65 (10.1)30 (10.2)35 (10.0)0.941 Disease parameters Mild (%)505 (78.5)221 (75.2)284 (81.4)0.067Moderate (%)138 (21.5)73 (24.8)65 (18.6)0.056 Timing parameters, median (IQR) Test positivity to infusion, days3 (2C4)2 (1C4)3 (2C5) ?0.001Symptom onset to infusion, days5 (4C7)4 (3C7)6 (5C8) 0.001 Outcomes (30\days) COVID\related hospitalization (%)48 (7.5)23 (7.8)25 (7.2)0.751COVID\related ED visit (%)21 (3.3)7 (2.4)14 (4.0)0.247Length of stay, median days (IQR)4 (2C6.5)4 (2C7.5)4 (2C6)0.794All\cause mortality (%)4 (0.6)3 (1.02)1 (0.29)0.238 Open in a separate window Abbreviations: BMI, body mass index (defined as weight in kilograms divided by height in metres squared); COVID\19, coronavirus Disease 2019; IQR, interquartile range. aBMI data not available for 10 of 643 patients. b Defined as any cardiovascular comorbidity including coronary artery disease, myocardial infarction, congestive heart failure or hypertension. c Defined as any pulmonary comorbidity including obstructive sleep apnea, chronic obstructive pulmonary disease or asthma. d Defined as active malignancy, prior solid organ or stem cell transplantation, living with HIV (regardless of CD4 count) or autoimmune disease requiring immunosuppressive therapy. In this single\centre study, 643 patients received either BAM or BAM/E and had similar rates of 30\day COVID\19\related hospitalization. It is plausible that the BAM/E did not outperform Nid1 BAM monotherapy due to higher rates of morbid obesity or a longer time from symptom onset to infusion in the Tetrabenazine (Xenazine) combination group. Groups had similar times from onset of symptoms to test date, and from referral to infusion. Therefore, the delay in receiving infusion in the BAM/E appears to be driven by waiting longer to seek care. We hypothesize that this delay in seeking care may have been due to the younger age in the BAM/E cohort. Compared with patients in clinical trials evaluating MAB, our study population had more advanced age, higher median BMI (33?kg/m2), more patients who self\identified as Black race (24%), and longer median duration of symptoms prior to infusion (5?days). 1 , 2 , 3 All patients in our study at had least one pre\defined risk factor for progression to severe COVID\19 per EUA criteria, compared.