| Outcome |
Relative effect
(95% CI) |
Absolute effect
(95% CI)1 |
Certainty of the Evidence
(GRADE) |
Clinical improvement
D28 |
RR: 1.21
(0.69 - 2.14) |
126 more per 1000
(from 186 fewer to 684 more)
|
Very low certainty
Reasons to downgrade
Risk of bias: Serious
Risk of bias downgraded by 1 level: Risk of bias downgraded by 1 level: some concerns regarding adequate randomization, deviation from intended intervention, and outcome measurement Inconsistency: Not serious Indirectness: Serious
despite a multicentre design this is a single study from a single country, therefore results in this population might not be generalizable to other settings. Imprecision: Very serious
due to very wide confidence interval consistent with the possibility for benefit and the possibility for harm
|
| 1 trials
Kumar S, 2020
32 participants
|
|
Itolizumab
726 per 1,000
(414 - 1000) |
Standard care
600
per 1,000 |
|
Clinical improvement
D60 |
Outcome not yet measured or reported
|
|
WHO progression score (level 7 or above)
D28 |
RR:
( - ) |
Zero events in both groups
|
Very low certainty
Reasons to downgrade
Risk of bias: Not serious Inconsistency: Not serious Indirectness: Serious
despite a multicentre design this is a single study from a single country, therefore results in this population might not be generalizable to other settings. Imprecision: Very serious
no events in both groups
|
| 1 trials
Kumar S, 2021
32 participants
|
|
Itolizumab
0 per 1,000
( - ) |
Standard care
0
per 1,000 |
|
WHO progression score (level 7 or above)
D60 |
Outcome not yet measured or reported
|
|
All-cause mortality
D28 |
RR: 0.15
(0.02 - 1.28) |
255 fewer per 1000
(from 294 fewer to 84 more)
|
Very low certainty
Reasons to downgrade
Risk of bias: Not serious Inconsistency: Not serious Indirectness: Serious
despite a multicentre design this is a single study from a single country, therefore results in this population might not be generalizable to other settings. Imprecision: Very serious
due to very wide confidence interval consistent with the possibility for benefit and the possibility for harm
|
| 1 trials
Kumar S, 2021
32 participants
|
|
Itolizumab
45 per 1,000
(6 - 384) |
Standard care
300
per 1,000 |
|
All-cause mortality
D60 |
Outcome not yet measured or reported
|
|
Viral negative conversion
D7 |
Outcome not yet measured or reported
|
|
Adverse events
|
RR: 2.05
(0.93 - 4.48) |
420 more per 1000
(from 28 fewer to 1000 more)
|
Low certainty
Reasons to downgrade
Risk of bias: Serious
Risk of bias downgraded by 1 level: some concerns regarding adequate randomization, outcome measurement and selection of the reported results 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 no effect/trivial effect and the possibility for harm
|
| 1 trials
Kumar S, 2021
32 participants
|
|
Itolizumab
820 per 1,000
(372 - 1000) |
Standard care
400
per 1,000 |
|
Serious adverse events
|
RR: 0.45
(0.11 - 1.87) |
165 fewer per 1000
(from 267 fewer to 261 more)
|
Very low certainty
Reasons to downgrade
Risk of bias: Serious
Risk of bias downgraded by 1 level: some concerns regarding adequate randomization, outcome measurement and selection of the reported results 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: Very serious
due to very wide confidence interval consistent with the possibility for benefit and the possibility for harm
|
| 1 trials
Kumar S, 2021
32 participants
|
|
Itolizumab
135 per 1,000
(33 - 561) |
Standard care
300
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
