3.2 Primary outcome
CPD, HTN, CVD, diabetes
CVD, REGRESSION, HTN, DIABETES
Based on univariate analyses, both groups demonstrated statistically similar mean (SD) changes on the 8-point COVID ordinal scale of increasing illness severity through day 14 (Aggrenox: 2.3 (1.8) vs control: 2.1 (2.0); p = 0.74) and day 28 (Aggrenox: 2.5 (1.7) vs control: 2.0 (2.2), p = 0.24). More specifically, the majority of patients (82.7%) in both study groups improved from days 1 to 14 (Aggrenox: 41 vs control: 40), more patients in the control group got worse (Aggrenox: 4 vs control: 6), and all other patients showed no change (n = 7, 7.1%). Similar trends were demonstrated when analyzing data through day 28, where 85.7% of patients improved from baseline (Aggrenox: 44 vs control: 40) and 10.2% of patients got worse (Aggrenox: 4 vs control: 6), while 2 patients (4.1%) in the control showed no change and 1 patient in each group (2.0%) was removed due to missing data. These data are presented in S2 Table in After controlling for other potential risk factors including: comorbidities (CPD, diabetes, CVD, HTN, Aids/HIV, Smoking status), DBP at baseline, recent use of NSAIDS and oral steroids, and baseline lab values (hemoglobin, WBC, lymphocytes, neutrophils, hematocrit, platelets, ALT/SGPT, bilirubin, AST/SGOT, glucose, BUN, creatinine, sodium, potassium, CRP, d-dimer, and ferritin, lactate dehydrogenase) there was no significant difference in the change in the composite COVID ordinal scale from baseline to day 14 and day 28 based on the treatment group (p = 0.32 and p = 0.31, respectively). After removing the lab value predictors which caused a large drop in sample size due to missing data, treatment group was still not a significant predictor of change in the composite COVID ordinal scale from baseline to day 14 (p = 0.23). However, for the day 28 linear regression model without lab values, treatment group was marginally significant in the full model (β = 0.86, p = 0.07) (S4 Table in Again, the multivariable ordinal logistic models for patients’ raw COVID ordinal scale measure at days 14 and 28 showed no significant differences between the treatment groups for all cumulative COVID scale levels (all p = 1.0); however, the models failed to fully converge even after allowing for uneven slopes (non-proportional odds). After applying both an uneven slopes assumption and stepwise selection methods to pair the model down to only treatment group, plus any remaining significant factors, only treatment group remained in both the day 14 and day 28 outcome models. When comparing those who received Aggrenox versus the control group in terms of illness severity at day 14, there were no significant differences for those who recovered and could resume normal activities versus everyone else (OR [95% CI]: 0.46 [0.14, 1.43], p = 0.18); those who were discharged versus those who were not (OR [95% CI]: 0.33 [0.08, 1.32], p = 0.12); those who were discharged or were still in the hospital without requiring oxygen versus those who required therapies or died (OR [95% CI]: 0.29 [0.06, 1.49], p = 0.14); those who were discharged or were still in hospital with or without oxygen only versus those who required more involved therapies or died (OR [95% CI]: 0.21 [0.02, 1.87], p = 0.16); those who were discharged or were still in hospital with or without only noninvasive therapy versus those who required invasive therapies or died (OR not estimable, p = 0.99); those who were discharged or were still in hospital with or without pulmonary therapy only versus those who required additional organ support or died (OR not estimable, p = 1.0). However, when comparing all surviving patients versus those who died, there was a significant difference (OR [95% CI]: 11.75 [1.29, 107.10], p = 0.03), suggesting that patients on Aggrenox have significantly higher odds of being alive versus dead on day 14. No significant differences were found between those who received Aggrenox and the control group in in terms of illness severity at day 28 (OR [95% CI]: 1.62 [0.52, 4.96], p = 0.40; 1.88 [0.51, 6.89], p = 0.34; 1.74 [0.39, 7.75], p = 0.47) when comparing those who recovered and could resume normal activities versus everyone else, those who were discharged versus those who were not, and all surviving patients versus those who died, respectively.