Outcome |
Relative effect (95% CI) |
Absolute effect (95% CI)1 |
Certainty of the Evidence (GRADE) |
Clinical improvement D28 |
RR: * |
|
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: Serious single study from a single institution therefore results in this population might not be generalizable to other settings Imprecision: Very serious all participants in both groups had an event
|
1 trials
Yethindra V, 2020
30 participants
|
|
Umifenovir 0 per 1,000 (* - *) |
Standard care 0 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: Serious Risk of bias downgraded by 1 level: some concerns regarding adequate randomization, deviation from intended intervention, and selection of the reported results Inconsistency: Not serious Indirectness: Not serious Imprecision: Very serious no events in both groups
|
2 trials
Yethindra, 2020; Yueping L, 2020
82 participants
|
|
Umifenovir 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: * |
Zero events in both groups
|
Very low certainty
Reasons to downgrade
Risk of bias: Serious Risk of bias downgraded by 1 level: some concerns regarding deviations from intended intervention in both studies, some concerns regarding randomization and selection of reported result in one study Inconsistency: Not serious Indirectness: Not serious Imprecision: Very serious no events in both groups
|
3 trials
Yethindra V, 2020; Yueping L, 2020; Yethindra V, 2020
214 participants
|
|
Umifenovir 0 per 1,000 ( - ) |
Standard care 0 per 1,000 |
|
All-cause mortality D60 |
Outcome not yet measured or reported
|
|
Viral negative conversion D7 |
RR: 1.03 (0.74 - 1.44) |
13 more per 1000 (from 113 fewer to 191 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
Yueping L, 2020; Ramachandran R, 2021
184 participants
|
|
Umifenovir 447 per 1,000 (321 - 625) |
Standard care 434 per 1,000 |
|
Adverse events
|
RR: 1.37 (0.38 - 4.97) |
31 more per 1000 (from 52 fewer to 335 more)
|
Low 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, is 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
Yueping L, 2020; Ramachandran R, 2021
184 participants
|
|
Umifenovir 116 per 1,000 (32 - 419) |
Standard care 84 per 1,000 |
|
Serious adverse events
|
RR: * |
Zero events in both groups
|
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, missing data, outcome measurement, and selection of reported results Inconsistency: Not serious Indirectness: Not serious We presume that the adverse event rates, and the corresponding relative risks, is similar across diverse settings; therefore not downgraded for indirectness Imprecision: Very serious no events in both groups
|
3 trials
Yethindra V, 2020; Yueping L, 2020; Ramachandran R, 2021
214 participants
|
|
Umifenovir 0 per 1,000 ( - ) |
Standard care 0 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