| Outcome |
Relative effect
(95% CI) |
Absolute effect
(95% CI)1 |
Certainty of the Evidence
(GRADE) |
Clinical improvement
D28 |
RR: 1.14
(0.92 - 1.41) |
62 more per 1000
(from 36 fewer to 182 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 benefit and the possibility for no effect/trivial effect
|
| 1 trials
Vlaar APJ, 2020
369 participants
|
|
Vilobelimab
507 per 1,000
(409 - 627) |
Placebo/Standard care
445
per 1,000 |
|
Clinical improvement
D60 |
Outcome not yet measured or reported
|
|
WHO progression score (level 7 or above)
D28 |
Outcome not yet measured or reported
|
|
WHO progression score (level 7 or above)
D60 |
Outcome not yet measured or reported
|
|
All-cause mortality
D28 |
RR: 0.74
(0.56 - 0.98) |
102 fewer per 1000
(from 173 fewer to 8 fewer)
|
Moderate certainty
Reasons to downgrade
Risk of bias: Not serious Inconsistency: Not serious Indirectness: Not serious
Imprecision: Serious
due to wide confidence interval consistent with the possibility for benefit and the possibility for no effect/trivial effect
|
| 2 trials
Vlaar APJ, 2020; Vlaar AJP 2022
399 participants
|
|
Vilobelimab
291 per 1,000
(220 - 385) |
Placebo/Standard care
393
per 1,000 |
|
All-cause mortality
D60 |
RR: 0.76
(0.59 - 0.99) |
109 fewer per 1000
(from 187 fewer to 5 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
Vlaar AJP, 2022
369 participants
|
|
Vilobelimab
346 per 1,000
(269 - 451) |
Placebo/Standard care
455
per 1,000 |
|
Viral negative conversion
D7 |
Outcome not yet measured or reported
|
|
Adverse events
|
RR: 0.99
(0.93 - 1.06) |
9 fewer per 1000
(from 63 fewer to 54 more)
|
Low certainty
Reasons to downgrade
Risk of bias: Not serious Inconsistency: Not serious Indirectness: Not serious
Imprecision: Very serious
due to very wide confidence interval consistent with the possibility for benefit and the possibility for harm
|
| 2 trials
Vlaar APJ, 2020; Vlaar AJP 2022
399 participants
|
|
Vilobelimab
894 per 1,000
(840 - 957) |
Placebo/Standard care
903
per 1,000 |
|
Serious adverse events
|
RR: 0.94
(0.80 - 1.10) |
37 fewer per 1000
(from 123 fewer to 62 more)
|
Low certainty
Reasons to downgrade
Risk of bias: Not serious Inconsistency: Not serious Indirectness: Not serious
Imprecision: Very serious
due to very wide confidence interval consistent with the possibility for benefit and the possibility for harm
|
| 2 trials
Vlaar APJ, 2020; Vlaar AJP 2022
399 participants
|
|
Vilobelimab
580 per 1,000
(493 - 678) |
Placebo/Standard care
617
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
