| Outcome |
Relative effect
(95% CI) |
Absolute effect
(95% CI)1 |
Certainty of the Evidence
(GRADE) |
Clinical improvement
D28 |
Outcome not yet measured or reported
|
|
Clinical improvement
D60 |
Outcome not yet measured or reported
|
|
Hospitalisation or death
|
RR: 0.20
(0.08 - 0.48) |
45 fewer per 1000
(from 52 fewer to 29 fewer)
|
Moderate certainty
Reasons to downgrade
Risk of bias: Not serious Inconsistency: Not serious Indirectness: Not serious
Multicentre study conducted across several countries, therefore not downgraded for indirectness Imprecision: Serious
due to wide confidence interval consistent with the possibility for benefit and the possibility for no effect/trivial effect
|
| 1 trials
Gupta A, 2021
1057 participants
|
|
Sotrovimab
11 per 1,000
(5 - 27) |
Placebo
57
per 1,000 |
|
WHO progression score (level 7 or above)
D28 |
RR: 0.08
(0.00 - 1.36) |
|
Low certainty
Reasons to downgrade
Risk of bias: Not serious Inconsistency: Not serious Indirectness: Not serious
Multicentre study conducted across several countries, therefore not downgraded for indirectness Imprecision: Very serious
due to very wide confidence interval consistent with the possibility for benefit and the possibility for harm
|
| 1 trials
Gupta A, 2021
1057 participants
|
|
Sotrovimab
0 per 1,000
( - ) |
Placebo
0
per 1,000 |
|
WHO progression score (level 7 or above)
D60 |
Outcome not yet measured or reported
|
|
All-cause mortality
D28 |
RR: 0.20
(0.01 - 4.16) |
3 fewer per 1000
(from 4 fewer to 12 more)
|
Moderate certainty
Reasons to downgrade
Risk of bias: Not serious Inconsistency: Not serious Indirectness: Not serious
Multicentre study conducted across several countries, therefore not downgraded for indirectness Imprecision: Serious
due to wide confidence interval consistent with the possibility for no effect/trivial effect and the possibility for harm
|
| 1 trials
Gupta A, 2021
1057 participants
|
|
Sotrovimab
1 per 1,000
(0 - 16) |
Placebo
4
per 1,000 |
|
All-cause mortality
D60 |
RR: 0.09
(0.01 - 1.64) |
9 fewer per 1000
(from 9 fewer to 6 more)
|
Moderate certainty
Reasons to downgrade
Risk of bias: Not serious Inconsistency: Not serious Indirectness: Not serious
Multicentre study conducted across several countries, therefore not downgraded for indirectness Imprecision: Serious
due to low number of participants/events
|
| 1 trials
Gupta A, 2021
1057 participants
|
|
Sotrovimab
1 per 1,000
(0 - 16) |
Placebo
9
per 1,000 |
|
Viral negative conversion
D7 |
RR: 0.92
(0.60 - 1.43) |
6 fewer per 1000
(from 29 fewer to 32 more)
|
Low certainty
Reasons to downgrade
Risk of bias: Serious
Risk of bias downgraded by 1 level: some concerns regarding missing data, and selection of the reported results Inconsistency: Not serious Indirectness: Not serious
Multicentre study conducted across several countries, therefore not downgraded for indirectness Imprecision: Serious
due to low number of participants/events
|
| 1 trials
Gupta A, 2022
1057 participants
|
|
Sotrovimab
68 per 1,000
(44 - 105) |
Placebo
74
per 1,000 |
|
Adverse events
|
RR: 0.95
(0.78 - 1.17) |
13 fewer per 1000
(from 58 fewer to 45 more)
|
Moderate certainty
Reasons to downgrade
Risk of bias: Not serious Inconsistency: Not serious Indirectness: Not serious
We presume that the adverse event rates and the corresponding relative risks, are similar across diverse settings, therefore not downgraded for indirectness Imprecision: Serious
due to wide confidence interval consistent with the possibility for benefit and the possibility for no effect/trivial effect
|
| 1 trials
Gupta A, 2021
1057 participants
|
|
Sotrovimab
251 per 1,000
(206 - 310) |
Placebo
265
per 1,000 |
|
Serious adverse events
|
RR: 0.31
(0.16 - 0.61) |
46 fewer per 1000
(from 56 fewer to 26 fewer)
|
Moderate certainty
Reasons to downgrade
Risk of bias: Not serious Inconsistency: Not serious Indirectness: Not serious
We presume that the adverse event rates and the corresponding relative risks, are similar across diverse settings, therefore not downgraded for indirectness Imprecision: Serious
due to low number of participants/events
|
| 1 trials
Gupta A, 2021
1057 participants
|
|
Sotrovimab
21 per 1,000
(11 - 40) |
Placebo
66
per 1,000 |
|
1The 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)
CI: Confidence interval; RR: Risk ratio
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 a 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
