Endpoint analyses | Statistical methods | SAS procedures |
---|---|---|
Primary endpoint A composite endpoint of mortality, hospital stay rate, and ECMO or mechanical intubation at 15 days after randomization | Pearson chi-square tests or Fisher exact tests Logistic regression adjusted for age, hypertension, and COPD | PROC FREQ PROC LOGISTC |
Secondary endpoints 1. Time to the clinical improvement 2. Inpatient mortality 3. Length of hospital stay 4. Duration of intubation for mechanical ventilation 5. Time to normal temperature 6. Maximum severity of COVID-19 illness | 1. Log-rank test, Kaplan-Meier curves Cox regression adjusted for age, hypertension, and COPD 2. Pearson chi-square tests or Fisher exact tests Logistic regression adjusted for age, hypertension, and COPD 3. Wilcoxon test; quantile regression 4. Wilcoxon test; Quantile regression 5. Log-rank test, Kaplan-Meier curves Cox regression adjusted for age, hypertension, and COPD 6. Pearson chi-square test; Cochran–Armitage trend test Proportional odds logistic regression | 1. PROC LIFETEST PROC PHREG 2. PROC FREQ PROC GENMOD 3. PROC NPAR1WAY 4. PROC NPAR1WAY 5. PROC LIFETEST PROC PHREG 6. PROC FREQ PROC LOGISTC |
Exploratory analyses  Clinical prognostic factors  Laboratory prognostic factors  Viral load  Cytokines levels and TMPRSS2 expression  Germline genomic factors | 1. Time to event data Log-rank tests, Kaplan-Meier curves, and Cox regressions 2. Categorical data Pearson chi-square tests and logistic regression 3. Interval data Student t/Wilcoxon tests, linear or quantile regressions 4. Longitudinal data Mixed-effect model repeated measure | 1. PROC LIFETEST PROC PHREG 2. PROC FREQ PROC LOGISTC 3. PROC TTEST PROC NPAR1WAY 4. PROC Mixed |
AE/SAE analyses 1. Incidence of AE/SAE 2. Frequency difference of AE and SAE 3. AE /SAE by relationship to the treatment 4. AE/SAE leading to premature discontinuation | For All AE/SAE Incidence rate estimation and testing Pearson chi-square tests or Fisher exact tests | PROC FREQ SAS Macros |
Other analyses 1. Baseline characteristics 2. Disposition status 3. Adherence 4. Site Effect | 1. Student t or Wilcoxon tests, Pearson chi-square or Fisher exact tests 2. Pearson chi-square tests 3. Pearson chi-square tests 4. Pearson chi-square tests, Student t or Wilcoxon tests, log-rank test | 1. PROC TTEST, PROC FREQ, PROC NPAR1WAY 2. PROC FREQ 3. PROC FREQ 4. PROC FREQ PROC LIFETEST PROC NPAR1WAY |