Results
diabetes, death, VTE, hypertension
COVID-19 PNEUMONIA, EVENT, REGRESSION, HYPERTENSION, DIABETES
Patient population: From September 1, 2020, through June 17, 2021, 775 potential participants were screened and provided informed consent of whom 657 were randomized. The enrollment location was available for 533 (81.1%) of the 657 randomized patients, of which 306 (57%) were classified as MC enrollment patients and 227 (43%) were classified as AUEC enrollment patients. The median age was 52 years (interquartile range [IQR]: 45, 58 years) for the MC patients and 55 years (IQR: 48, 60 years; vs. MC, p-value = 0.005) for AUEC patients; overall 58.4% were female with no significant difference between groups (Table 
Sample Size required for each treatment arm to have 80% power to detect a 50% risk reduction with alpha = 0.05 for a range of reference event rates with estimates based on the adjudicated primary clinical outcomeWhen compared to MC enrollment patients, AUEC enrollment patients were enrolled sooner after symptom onset (median 3 days [IQR 1, 6 days] vs. 9 days [IQR 5, 12 days] days; p < 0.001) and initiated study treatment sooner (median 8 days (IQR 5, 11 days) vs. 13 days (IQR 10, 15 days), p < 0.001). AUEC enrollment patients were more likely to be non-Hispanic Black (18.9% vs. 6.2% p < 0.001) or Hispanic (29.1% vs. 10.5% p < 0.001) compared to MC enrollment patients. Regional enrollment differed such that AUEC patients were more often enrolled in the Southern US (78%) and MC patients were more often enrolled in Western US patients (55.6%, p < 0.001). In a multivariable- logistic regression model, significant predictors of AUEC enrollment as compared to MC enrollment included shorter time between positive COVID-test and randomization, OR = 0.77 per day (95% CI- 0.73, 0.82), older age, OR = 1.04 per year (95% CI 1.01, 1.07), Black non-Hispanic race/ethnicity, OR = 4.38 (95% CI 2.10, 9.10) Hispanic ethnicity, OR = 5.94 (95% CI 3.37, 10.47) and higher body mass index (BMI), OR = 1.05 per km/mClinical Outcomes: Among the 533 patients with enrollment location data, 20 (3.8%) developed the adjudicated composite primary outcome, of which 18 of 227 (7.9%) occurred among the AUEC enrollment patients and two of 306 (0.7%) occurred among the MC enrollment patients (p < 0.001) (Fig. All 20 participants experiencing a primary composite endpoint were hospitalized for COVID-19 pneumonia and one also had VTE. One patient death occurred due to COVID-19 pneumonia and was in the AUEC enrollment group (Table The unadjusted hazards of the adjudicated primary outcome were 12.57 (95% CI: 2.92, 54.19) higher for those enrolled through AUEC as compared to those enrolled through the MC pathway. In Cox regression analysis with inverse probability weighting using a propensity score accounting for age, sex, time from COVID test to randomization, race/ethnicity, log of CRP level, BMI, hypertension and diabetes, enrollment in the AUEC pathway remained significantly associated with the adjudicated primary outcome, adjusted HR 3.40 (95% CI 1.46, 7.93). The sensitivity analysis results from the multivariable-adjusted Cox model were consistent but attenuated, adjusted HR 2.46 (95% CI 1.03, 5.88).