| Outcome |
Relative effect
(95% CI) |
Absolute effect
(95% CI)1 |
Certainty of the Evidence
(GRADE) |
Clinical improvement
D28 |
RR: 1.03
(0.90 - 1.17) |
27 more per 1000
(from 90 fewer to 153 more)
|
Very low certainty
Reasons to downgrade
Risk of bias: Serious
Risk of bias downgraded by 1 level: some concerns regarding 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
Bosteels C, 2021
81 participants
|
|
Sargramostim
930 per 1,000
(812 - 1000) |
Standard care
902
per 1,000 |
|
Clinical improvement
D60 |
RR: 1.04
(0.82 - 1.31) |
15 more per 1000
(from 68 fewer to 117 more)
|
Very low certainty
Reasons to downgrade
Risk of bias: Serious
Risk of bias downgraded by 1 level: some concerns or high risk regarding adequate randomisation, deviation from intended intervention, missing data and outcome measurement 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
Bosteels C, 2021; NCT04411680, 2022
204 participants
|
|
Sargramostim
392 per 1,000
(309 - 493) |
Standard care
376
per 1,000 |
|
WHO progression score (level 7 or above)
D28 |
RR: 0.78
(0.45 - 1.35) |
75 fewer per 1000
(from 188 fewer to 119 more)
|
Very low certainty
Reasons to downgrade
Risk of bias: Serious
Risk of bias downgraded by 1 level: some concerns or high risk regarding adequate randomization, and missing data 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
NCT04411680, 2022
123 participants
|
|
Sargramostim
266 per 1,000
(153 - 460) |
Standard care
341
per 1,000 |
|
WHO progression score (level 7 or above)
D60 |
Outcome not yet measured or reported
|
|
All-cause mortality
D28 |
RR: 0.87
(0.37 - 2.06) |
12 fewer per 1000
(from 59 fewer to 100 more)
|
Very low certainty
Reasons to downgrade
Risk of bias: Serious
Risk of bias downgraded by 1 level: some concerns regarding adequate randomization, and deviation from intended intervention 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
Bosteels C, 2021; NCT04411680 2022
204 participants
|
|
Sargramostim
82 per 1,000
(35 - 194) |
Standard care
94
per 1,000 |
|
All-cause mortality
D60 |
RR: 0.66
(0.34 - 1.29) |
64 fewer per 1000
(from 124 fewer to 55 more)
|
Very low certainty
Reasons to downgrade
Risk of bias: Serious
Risk of bias downgraded by 1 level: some concerns regarding adequate randomization, and deviation from intended intervention 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
Bosteels C, 2021; NCT04411680 2022
204 participants
|
|
Sargramostim
124 per 1,000
(64 - 243) |
Standard care
188
per 1,000 |
|
Viral negative conversion
D7 |
Outcome not yet measured or reported
|
|
Adverse events
|
RR: 0.97
(0.82 - 1.14) |
23 fewer per 1000
(from 136 fewer to 105 more)
|
Very low certainty
Reasons to downgrade
Risk of bias: Serious
Risk of bias downgraded by 1 level: some concerns or high risk adequate randomisation, regarding deviation from intended intervention, missing data and outcome measurement 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
|
| 2 trials
Bosteels C, 2021; NCT04411680, 2022
204 participants
|
|
Sargramostim
730 per 1,000
(617 - 858) |
Standard care
753
per 1,000 |
|
Serious adverse events
|
RR: 0.83
(0.34 - 2.02) |
36 fewer per 1000
(from 140 fewer to 216 more)
|
Very low certainty
Reasons to downgrade
Risk of bias: Serious
Risk of bias downgraded by 1 level: some concerns regarding adequate randomization, deviation from intended intervention, outcome measurement and selection of the reported results 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
Bosteels C, 2021; NCT04411680 2022
204 participants
|
|
Sargramostim
176 per 1,000
(72 - 428) |
Standard care
212
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
