| Outcome |
Relative effect
(95% CI) |
Absolute effect
(95% CI)1 |
Certainty of the Evidence
(GRADE) |
Clinical improvement
D28 |
RR: 1.06
(0.96 - 1.17) |
39 more per 1000
(from 26 fewer to 111 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
Patel J, 2021
806 participants
|
|
Otilimab
689 per 1,000
(624 - 761) |
Placebo
650
per 1,000 |
|
Clinical improvement
D60 |
RR: 0.98
(0.89 - 1.07) |
14 fewer per 1000
(from 78 fewer to 50 more)
|
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
patel J, 2021
806 participants
|
|
Otilimab
695 per 1,000
(632 - 759) |
Placebo
710
per 1,000 |
|
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: 0.88
(0.72 - 1.08) |
30 fewer per 1000
(from 70 fewer to 20 more)
|
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
|
| 2 trials
Patel J, 2021; NCT04376684 2022
1156 participants
|
|
Otilimab
219 per 1,000
(179 - 269) |
Placebo
249
per 1,000 |
|
All-cause mortality
D60 |
RR: 0.94
(0.79 - 1.12) |
18 fewer per 1000
(from 61 fewer to 35 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
Patel J, 2021; NCT04376684 2022
1156 participants
|
|
Otilimab
275 per 1,000
(231 - 327) |
Placebo
292
per 1,000 |
|
Viral negative conversion
D7 |
Outcome not yet measured or reported
|
|
Adverse events
|
RR: 1.03
(0.94 - 1.14) |
20 more per 1000
(from 39 fewer to 92 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
Patel J, 2021
806 participants
|
|
Otilimab
677 per 1,000
(618 - 750) |
Placebo
658
per 1,000 |
|
Serious adverse events
|
RR: 0.92
(0.78 - 1.08) |
33 fewer per 1000
(from 90 fewer to 33 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
Patel J, 2021; NCT04376684 2022
1156 participants
|
|
Otilimab
377 per 1,000
(320 - 443) |
Placebo
410
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
