Summary of findings 1. Bamlanivimab compared to placebo in non‐hospitalised individuals with COVID‐19 (asymptomatic or mild disease).
| Bamlanivimab compared to placebo in non‐hospitalised individuals with COVID‐19 (asymptomatic or mild disease) | |||||||
| Patient or population: non‐hospitalised individuals with COVID‐19 Setting: outpatient Intervention: bamlanivimab Comparison: placebo | |||||||
| Outcomes | Dose |
Anticipated absolute effects* (95% CI) |
Relative effect (95% CI) | N° of participants (studies) | Certainty in the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with SARS‐CoV‐2‐specific mAb | ||||||
| Mortality by day 30 | Bamlanivimab 0.7 g | 0 per 1000 | 0 per 1000 | Not estimable | 101 bamlanivimab/156 placebo (1 RCT) |
⊕⊕⊖⊖ Lowa |
No events observed. We are uncertain whether 0.7 g bamlanivimab has any impact on mortality at up to day 30. |
| Bamlanivimab 2.8 g | 0 per 1000 | 0 per 1000 | Not estimable | 107 bamlanivimab/156 placebo (1 RCT) |
No events observed. We are uncertain whether 2.8 g bamlanivimab has any impact on mortality at up to day 30. | ||
| Bamlanivimab 7.0 g | 0 per 1000 | 0 per 1000 | Not estimable | 101 bamlanivimab/156 placebo (1 RCT) |
No events observed. We are uncertain whether 7.0 g bamlanivimab has any impact on mortality at up to day 30. | ||
| Mortality by day 60 | Not reported | ‐ | ‐ | ‐ | ‐ | ‐ | We did not identify any study reporting this outcome. |
| Clinical progression/improvement of symptoms | Not reported | ‐ | ‐ | ‐ | ‐ | ‐ | We did not identify any study reporting this outcome. |
| Quality of life | Not measured | ‐ | ‐ | ‐ | ‐ | ‐ | We did not identify any study reporting this outcome. |
| Admission to hospital by day 30 | Bamlanivimab 0.7 g | 58 per 1000 |
10 per 1000 (1 to 77) |
RR 0.17 (0.02 to 1.33) |
257 (1 RCT) |
⊕⊕⊖⊖ Lowb |
Bamlanivimab 0.7 g may decrease hospital admission at day 30. |
| Bamlanivimab 2.8 g | 58 per 1000 |
18 per 1000 (4 to 85) |
RR 0.32 (0.07 to 1.47) |
263 (1 RCT) |
Bamlanivimab 0.7 g may decrease hospital admission at day 30. | ||
| Bamlanivimab 7.0 g | 58 per 1000 |
20 per 1000 (5 to 90) |
RR 0.34 (0.08 to 1.56) |
257 (1 RCT) |
Bamlanivimab 0.7 g may decrease hospital admission at day 30. | ||
| Adverse events: all grades | Bamlanivimab 0.7 g | 269 per 1000 |
267 per 1000 (178 to 404) |
RR 0.99 (0.66 to 1.50) |
257 (1 RCT) |
⊕⊕⊖⊖ Lowb |
Bamlanivimab 0.7 g may have little to no effect on all‐grade adverse events. |
| Bamlanivimab 2.8 g | 269 per 1000 |
242 per 1000 (159 to 372) |
RR 0.90 (0.59 to 1.38) |
263 (1RCT) |
Bamlanivimab 2.8 g may have little to no effect on all‐grade adverse events. | ||
| Bamlanivimab 7.0 g | 269 per 1000 |
218 per 1000 (140 to 342) |
RR 0.81 (0.52 to 1.27) |
257 (1 RCT) |
Bamlanivimab 7.0 g may have little to no effect on all‐grade adverse events. | ||
| Serious adverse events | Bamlanivimab 0.7 g | 6 per 1000 |
3 per 1000 (0 to 80) |
RR 0.51 (0.02 to 12.47) |
257 (1 RCT) |
⊕⊕⊖⊖ Lowb |
There were too few who experienced serious adverse events to determine whether bamlanivimab 0.7 g made a difference. |
| Bamlanivimab 2.8 g | 6 per 1000 |
3 per 1000 (0 to 76) |
RR 0.48 (0.02 to 11.78) |
263 (1 RCT) |
There were too few who experienced serious adverse events to determine whether bamlanivimab 2.8 g made a difference. | ||
| Bamlanivimab 7.0 g | 6 per 1000 |
3 per 1000 (0 to 80) |
RR 0.51 (0.02 to 12.47) |
257 (1 RCT) |
There were too few who experienced serious adverse events to determine whether bamlanivimab 7.0 g made a difference. | ||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk on the comparison group and the relative effect of the intervention (and its 95% confidence interval). CI: confidence interval; mAb: monoclonal antibody; RCT: randomised controlled trial; RR: risk ratio | |||||||
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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. | |||||||
aDowngraded two levels for very serious imprecision, no events observed, effect not estimable bDowngraded two levels for very serious imprecision, because of small sample size, low number of events and/or wide confidence interval.