Table 3.
Secondary outcomes
| Azithromycin plus usual care (n=500) | Usual care alone (n=629) | Estimated treatment effect (95% CI) | p value | ||
|---|---|---|---|---|---|
| Sustained recovery | 317/500 (63%) | 414/629 (66%) | .. | .. | |
| Time to sustained recovery (days) | 19 (7 to not reached) | 20 (7 to not reached) | 0·94 (0·81 to 1·09)* | 0·39 | |
| Alleviation of all symptoms | 401/420 (95%) | 473/505 (94%) | .. | .. | |
| Time to alleviation of all symptoms (days) | 3 (1 to 7) | 3 (1 to 7) | 1·04 (0·91 to 1·19)* | 0·57 | |
| Sustained alleviation of all symptoms | 338/422 (80%) | 425/510 (83%) | .. | .. | |
| Time to sustained alleviation of all symptoms (days) | 8 (3 to 27) | 10 (3 to 24) | 0·94 (0·81 to 1·09)* | 0·40 | |
| Initial reduction of severity of symptoms | 449/494 (91%) | 554/622 (89%) | .. | .. | |
| Time to initial reduction of severity of symptoms (days) | 4 (2 to 10) | 4 (1 to 11) | 0·99 (0·88 to 1·13)* | 0·91 | |
| Rating of how well participant feels (1 worst, 10 best) | |||||
| Day 7 | 7·2 (1·8) [484] | 7·1 (1·9) [620] | 0·10 (−0·12 to 0·32)† | 0·36 | |
| Day 14 | 7·8 (1·8) [484] | 7·7 (1·7) [613] | 0·08 (−0·16 to 0·32)† | 0·51 | |
| Day 21 | 8·0 (1·7) [421] | 8·0 (1·6) [539] | 0·03 (−0·25 to 0·30)† | 0·86 | |
| Day 28 | 8·0 (1·7) [497] | 8·3 (1·6) [612] | −0·15 (−0·46 to 0·16)† | 0·33 | |
| Wellbeing (WHO-5 Well-Being Index score) | |||||
| Day 14 | 45·3 (23·8) [472] | 44·1 (24·1) [601] | 0·61 (−1·89 to 3·11)† | 0·63 | |
| Day 28 | 52·9 (23·9) [474] | 53·4 (24·3) [590] | −0·06 (−2·56 to 2·44)† | 0·96 | |
| Self-reported contact with one or more health-care services | 255/499 (51%) | 323/628 (51%) | 1·00 (0·89 to 1·12)‡ | 0·99 | |
| General practitioner reported contact with one or more health-care services | 173/287 (60%) | 200/387 (52%) | 1·16 (1·01 to 1·32)‡ | 0·039 | |
| Prescription of antibiotics | 20/271 (7%) | 26/353 (7%) | 1·00 (0·57 to 1·76)§ | >0·99 | |
| Hospital assessment without admission | 9/500 (2%) | 11/629 (2%) | 1·03 (0·43 to 2·46)§ | >0·99 | |
| Oxygen administration | 10/497 (2%) | 15/625 (2%) | 0·84 (0·38 to 1·85)§ | 0·69 | |
| Mechanical ventilation | 2/496 (<1%) | 5/625 (1%) | 0·50 (0·10 to 2·59)§ | 0·47 | |
| Intensive care unit admission | 3/495 (1%) | 5/625 (1%) | 0·76 (0·18 to 3·15)§ | >0·99 | |
Data are n/N (%), median (IQR), or mean (SD) [n]. All secondary outcome analyses were analysed in the concurrent randomisation analysis population but restricted to those in the azithromycin plus usual care and usual care alone groups. HR=hazard ratio.
Estimated HR derived from a Cox proportional hazard model adjusted for age, comorbidities at baseline, duration of illness, and eligibility for azithromycin at baseline, with 95% CI.
Mixed effect model adjusted for age, comorbidity, duration of illness, eligibility for azithromycin at baseline, and time. Participant was fitted as a random effect; WHO-5 Well-Being Index score was also adjusted for the score at baseline.
Relative risk adjusted for age, comorbidities at baseline, duration of illness, and eligibility for azithromycin at baseline.
Unadjusted relative risk due to low event rate.