Table 2.
Primary and secondary outcomes
| Molnupiravir plus usual care | Usual care | Estimated treatment effect (95% BCI) | Estimated benefit (95% BCI) | Probability of superiority | ||
|---|---|---|---|---|---|---|
| Primary outcomes | ||||||
| Hospitalisations | 103 | 96 | .. | .. | .. | |
| Deaths | 3 | 5 | .. | .. | .. | |
| Hospitalisation or death | 105/12 529 (1%) | 98/12 525 (1%) | 1·06 (0·81–1·41)* | .. | 0·33* | |
| Secondary outcomes | ||||||
| First reported recovery | 9728/12 403 (78%) | 8374/12 140 (69%) | .. | .. | .. | |
| Days to first reported recovery | 9 (5–23) | 15 (7–not reached) | 1·36 (1·32–1·40)† | 4·2 (3·8–4·6)† | >0·99† | |
| Early sustained recovery | 3628/11 395 (32%) | 2446/10 823 (23%) | 1·62 (1·53–1·72)‡ | .. | >0·99‡ | |
| Sustained recovery | 8547/12 403 (69%) | 7302/12 140 (60%) | .. | .. | .. | |
| Days to sustained recovery | 21 (10–not reached) | 24 (14–not reached) | 1·24 (1·21–1·28)† | 3·5 (3·0–3·9)† | >0·99† | |
| Alleviation of all symptoms | 8992/9664 (93%) | 8351/9395 (89%) | .. | .. | .. | |
| Days to alleviations of all symptoms | 4 (2–7) | 4 (2–9) | 1·18 (1·15–1·22)† | 0·66 (0·54–0·78)† | >0·99† | |
| Sustained alleviation of all symptoms | 8164/9664 (84%) | 7510/9395 (80%) | .. | .. | .. | |
| Days to sustained alleviation of all symptoms | 9 (3–22) | 12 (4–25) | 1·15 (1·11–1·19)† | 2·01 (1·58–2·45)† | >0·99† | |
| Initial reduction of symptom severity | 10 850/12 375 (88%) | 9819/12 123 (81%) | .. | .. | .. | |
| Days to initial reduction of symptom severity | 7 (4–14) | 9 (5–19) | 1·28 (1·24–1·31)† | 1·8 (1·60–2·00) † | >0·99† | |
| Participant rating of wellness§ | ||||||
| Day 7 | 7·3 (1·7) | 6·8 (1·8) | 0·5 (0·5–0·6)¶ | .. | <0·0001¶ | |
| Day 14 | 7·9 (1·7) | 7·6 (1·7) | 0·3 (0·2–0·3)¶ | .. | <0·0001¶ | |
| Day 21 | 8·2 (1·6) | 8·0 (1·7) | 0·2 (0·1–0·2)¶ | .. | <0·0001¶ | |
| Day 28 | 8·4 (1·5) | 8·3 (1·6) | 0·2 (0·1–0·2)¶ | .. | <0·0001¶ | |
| New infections in household | 3887/10 803 (36%) | 3873/10 548 (37%) | 0·97 (0·91–1·02)* | .. | 0·88* | |
| Contact with health and social care services | ||||||
| NHS 111 | 583/12 401 (5%) | 776/12 134 (6%) | 0·72 (0·64–0·80)* | .. | >0·99* | |
| General practitioner | 2425/12 401 (20%) | 2876/12 135 (24%) | 0·77 (0·73–0·82)* | .. | >0·99* | |
| Ambulance service (not hospitalised) | 342/12 396 (3%) | 331/12 120 (3%) | 1·01 (0·87–1·18)* | .. | 0·46* | |
| Community nurse | 265/12 401 (2%) | 275/12 131 (2%) | 0·94 (0·79–1·11)* | .. | 0·78* | |
| Physiotherapist | 141/12 401 (1%) | 90/12 131 (1%) | 1·55 (1·18–2·01)* | .. | 0·0006* | |
| Counsellor | 91/12 401 (1%) | 106/12 131 (1%) | 0·84 (0·63–1·10)* | .. | 0·90* | |
| Social worker | 27/12 401 (<1%) | 32/12 131 (<1%) | 0·84 (0·49–1·35)* | .. | 0·78* | |
| Home carer | 88/12 400 (1%) | 95/12 129 (1%) | 0·90 (0·66–1·20)* | .. | 0·78* | |
| Occupational therapist | 261/12 400 (2%) | 240/12 131 (2%) | 1·07 (0·90–1·26)* | .. | 0·26* | |
| Hospital emergency department | 702/12 401 (6%) | 674/12 132 (6%) | 1·02 (0·92–1·14)* | .. | 0·37* | |
| Outpatient respiratory clinic | 234/12 401 (2%) | 252/12 130 (2%) | 0·90 (0·75–1·07)* | .. | 0·88* | |
| Hospital at home for COVID-19 | 350/12 401 (3%) | 430/12 131 (4%) | 0·79 (0·68–0·91)* | .. | >0·99* | |
| Other services | 583/12 401 (5%) | 646/12 130 (5%) | 0·87 (0·77–0·98)* | .. | 0·99* | |
Data are n, n/N (%), median (IQR), or mean (SD). 95% BCI=95% Bayesian credible interval.
Bayesian logistic regression model adjusted for age, vaccination status, and comorbidity at baseline. An odds ratio <1 favoured molnupiravir plus usual care over usual care only.
Estimated benefit in median time to recovery derived from a Bayesian piecewise exponential model adjusted for age and comorbidity at baseline. A positive value in estimated benefit (or hazard ratio >1) favoured molnupiravir plus usual care compared with usual care only.
Bayesian logistic regression model adjusted for age, vaccination status, and comorbidity at baseline. An odds ratio >1 favoured molnupiravir plus usual care compared with usual care only.
0 was the worst score and 10 was the best. In the molnupiravir plus usual care group, data were available for 11 837 participants at day 7, 11 505 at day 14, 10 752 at day 21, and 10 643 at day 28; the corresponding figures in the usual care group were 11 231, 10 739, 9697, and 9774.
Linear mixed-effect model adjusted for age, comorbidity, and vaccination status, with participants fitted as a random effect. An estimated mean difference with (95% CIs rather than 95% BCIs) >0 favoured molnupiravir plus usual care compared with usual care only. p values rather than a probability of superiority are provided.