Summary of findings 3. Bamlanivimab compared to placebo for postexposure prophylaxis of COVID‐19.
| Bamlanivimab compared to placebo in previously uninfected and unvaccinated residents and staff of skilled nursing and assisted living facilities with at least one confirmed index case | ||||||
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Patient or population: SARS‐CoV‐2 uninfected people without defined exposure, or with potential exposure to SARS‐CoV‐2 Setting: preventive measures Intervention: bamlanivimab Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | N° of participants (studies) | Certainty in the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with bamlanivimab | |||||
| Infection with SARS‐CoV‐2 by day 30 | 232 per 1000 |
176 per 1000 (137 to 228) |
RR 0.76 (0.59 to 0.98) |
966 (1 RCT) | ⊕⊕⊕⊝ Moderatea |
Bamlanivimab probably decreases infection with SARS‐CoV‐2 by day 30. Participants may have been exposed to variants such SARS‐CoV‐2 wild‐type. |
| Development of clinical COVID‐19 symptoms within 30 days | — | — | — | — | — | We identified no studies reporting development of clinical COVID‐19 symptoms. |
| All‐cause mortality by day 60 | 12 per 1000 |
10 per 1000 (3 to 34) |
RR 0.83 (0.25 to 2.70) |
966 (1 RCT) | ⊕⊕⊝⊝ Lowb |
Bamlanivimab may result in little to no difference on mortality by day 60. Participants may have been exposed to variants such SARS‐CoV‐2 wild‐type. |
| Admission to hospital within 30 days | — | — | — | — | — | We identified no studies reporting admission to hospital. |
| Quality of life at longest follow‐up | — | — | — | — | — | We identified no studies reporting quality of life. |
| Adverse events: grade 1 to 2 | — | — | — | — | — | We identified no studies reporting grade 1 to 2 adverse events. |
| Adverse events: grade 3 to 4 | — | — | — | — | — | We identified no studies reporting grade 3 to 4 adverse events. |
| Adverse events: all grade by week 8 | 178 per 1000 |
200 per 1000 (153 to 260) |
RR 1.12 (0.86 to 1.46) |
966 (1 RCT) | ⊕⊕⊝⊝ Lowc |
Bamlanivimab may increase the occurrence of all‐grade adverse events by week 8. Participants may have been exposed to variants such SARS‐CoV‐2 wild‐type. |
| Serious adverse events by week 8 | 27 per 1000 |
39 per 1000 (20 to 78) |
RR 1.46 (0.73 to 2.91) |
966 (1 RCT) | ⊕⊕⊝⊝ Lowb |
Bamlanivimab may increase the occurrence of serious adverse events by week 8 slightly. Participants may have been exposed to variants such SARS‐CoV‐2 wild‐type. |
| *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; SARS‐CoV‐2: severe acute respiratory syndrome coronavirus 2. | ||||||
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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 one level for serious imprecision, because sample size did not meet optimal information size (2046 participants). bDowngraded two levels for very serious imprecision, because of low number of events and wide confidence intervals. cDowngraded two levels for serious imprecision, because sample size did not meet optimal information size (12,078 participants) and wide confidence intervals.