Table 2.
Comparison of primary and secondary binary outcomes, and time-to-event in the ITT populations
| Azithromycin group | Standard care group |
Comparison of proportions |
Time-to-event, hazard ratio (95% CI), p value | |||
|---|---|---|---|---|---|---|
| Odds ratio (95% CI), p value | Risk difference (95% CI) | |||||
| Primary outcome | ||||||
| Hospitalisation or death (ITT) | 15/145 (10%) | 17/147 (12%) | .. | .. | .. | |
| Unadjusted | .. | .. | 0·88 (0·42 to 1·84), 0·74 | −1·2% (−8·4 to 5·9) | 0·79 | |
| Adjusted | .. | .. | 0·91 (0·43 to 1·92), 0·80 | −1·0% (−8·0 to 6·1) | 0·95 (0·46 to 1·96), 0·89 | |
| Fully adjusted | .. | .. | 0·91 (0·42 to 1·97), 0·82 | −1·2% (−8·2 to 5·7) | 0·99 (0·49 to 2·00), 0·99 | |
| Hospitalisation or death (ITT positive) | 11/75 (15%) | 11/75 (15%) | .. | .. | .. | |
| Unadjusted | .. | .. | 1·00 (0·40 to 2·47), 1·00 | 0·0% (−11·3 to 11·3) | 0·78 | |
| Adjusted | .. | .. | 1·02 (0·40 to 2·57), 0·97 | 0·3% (−10·8 to 11·4) | 1·17 (0·49 to 2·77), 0·72 | |
| Full adjusted | .. | .. | 1·11 (0·43 to 2·90), 0·83 | 0·8% (−10·1 to 11·7) | 1·30 (0·52 to 3·21), 0·57 | |
| Secondary outcomes | ||||||
| Level 2 or 3 ventilation or death | 2/145 (1%) | 2/147 (1%) | p=1·00 | .. | .. | |
| All-cause mortality | 1/145 (1%) | 1/147 (1%) | p=1·00 | .. | .. | |
| Progression to pneumonia | 0/119 | 2/114 (2%) | p=0·24 | .. | .. | |
Comparisons for the primary outcome were performed using a logistic regression model adjusted for stratification factors centre, hypertension, diabetes, and sex (adjusted), or fully adjusted for centre, hypertension, diabetes, sex, age 65 years and older, presence of chronic lung disease, and treatment for cancer. Comparisons for the secondary outcomes were performed using Fisher's exact test because of small numbers of events. ITT=intention to treat.