Summary of findings 4. Sotrovimab compared to placebo in non‐hospitalised individuals with COVID‐19 (asymptomatic and mild disease).
| Sotrovimab compared to placebo in non‐hospitalised individuals with COVID‐19 (asymptomatic and mild disease) | ||||||
| Patient or population: non‐hospitalised individuals with COVID‐19 (asymptomatic and mild disease) Setting: outpatients Intervention: sotrovimab Comparison: placebo | ||||||
| Outcome |
Anticipated absolute effects* (95% CI) |
Relative effect (95% CI) | № of participants** (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with sotrovimab | |||||
| Mortality by day 30 | 3 per 1000 |
1 per 1000 (0 to 28) |
RR 0.33 (0.01 to 8.18) | 583 (1 RCT) |
⊕⊕⊝⊝ Lowa | There were too few who experienced mortality to determine whether sotrovimab made a difference. |
| Mortality by day 60 | not reported | ‐ | ‐ | ‐ | We did not identify any study reporting this outcome. | |
| Clinical progression: oxygen requirement (≥ 5 WHO scale) | 65 per 1000 |
7 per 1000 (1 to 29) |
RR 0.11 (0.02 to 0.45) | 583 (1 RCT) |
⊕⊕⊝⊝ Lowb | Sotrovimab may reduce the number of participants with any oxygen requirement. |
| Clinical progression: IMV or death (≥ 7 WHO scale) | 10 per 1000 |
1 per 1000 (0 to 28) |
RR 0.14 (0.01 to 2.76) | 583 (1 RCT) |
⊕⊕⊝⊝ Lowa | There were too few who experienced an event to determine whether sotrovimab made a difference. |
| Quality of life by day 30 | not reported | ‐ | ‐ | ‐ | We did not identify any study reporting this outcome. | |
| Admission to hospital or death by day 30 | 72 per 1000 |
10 per 1000 (3 to 35) |
RR 0.14 (0.04 to 0.48) | 583 (1 RCT) |
⊕⊕⊝⊝ Lowb | Sotrovimab may reduce the occurrence of hospital admissions or death. |
| Adverse events: all grades | 194 per 1000 |
169 per 1000 (128 to 225) |
RR 0.87 (0.66 to 1.16) | 868 (1 RCT) |
⊕⊕⊝⊝ Lowb |
Sotrovimab may have little to no effect on the occurrence of all grade adverse events. |
| Adverse events: grades 3 and 4 | 62 per 1000 |
16 per 1000 (7 to 37) |
RR 0.26 (0.12 to 0.60) | 868 (1 RCT) |
⊕⊕⊝⊝ Lowb | Sotrovimab may reduce the occurrence of grade 3‐4 adverse events. |
| Serious adverse events | 59 per 1000 |
16 per 1000 (7 to 37) |
RR 0.27 (0.12 to 0.63) | 868 (1 RCT) |
⊕⊕⊝⊝ Lowb | Sotrovimab may reduce the occurrence of serious adverse events. |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
**This study included a total of 868 participants. All were 868 participants randmoised were included in the safety set, but only 583 participants were analysed in the efficacy set. CI: confidence interval; RR: risk ratio; RCT: randomised controlled trial | ||||||
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GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is the possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
a Downgraded two levels for very serious imprecision, because of low sample size, very low number of events and very wide confidence interval
b Downgraded two levels for very serious imprecision, because of low sample size and/or low number of events