| Outcome |
Relative effect
(95% CI) |
Absolute effect
(95% CI)1 |
Certainty of the Evidence
(GRADE) |
Clinical improvement
D28 |
Outcome not yet measured or reported
|
|
Clinical improvement
D60 |
Outcome not yet measured or reported
|
|
Hospitalisation or death
|
RR: 0.38
(0.03 - 5.02) |
7 fewer per 1000
(from 12 fewer to 48 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 low number of participants/events
|
| 2 trials
Mukae H, 2022 (1); Mukae H, 2022 (2)
497 participants
|
|
Ensitrelvir
5 per 1,000
(0 - 60) |
Placebo
12
per 1,000 |
|
WHO progression score (level 7 or above)
D28 |
RR:
( - ) |
Zero events in both groups
|
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
no events in both groups
|
| 2 trials
Mukae H, 2022 (1), Mukae H, 2022 (2)
497 participants
|
|
Ensitrelvir
0 per 1,000
( - ) |
Placebo
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
|
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
no events in both groups
|
| 2 trials
Mukae H, 2022 (1); Mukae H, 2022 (2)
497 participants
|
|
Ensitrelvir
0 per 1,000
( - ) |
Placebo
0
per 1,000 |
|
All-cause mortality
D60 |
Outcome not yet measured or reported
|
|
Viral negative conversion
D7 |
RR: 1.14
(1.07 - 1.22) |
123 more per 1000
(from 61 more to 193 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 low number of participants/events
|
| 2 trials
Mukae H, 2022 (1); Mukae H, 2022 (2)
374 participants
|
|
Ensitrelvir
1000 per 1,000
(938 - 1000) |
Placebo
877
per 1,000 |
|
Adverse events
|
RR: 1.30
(1.01 - 1.68) |
95 more per 1000
(from 3 more to 216 more)
|
Moderate 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, 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
|
| 2 trials
Mukae H, 2022 (1); Mukae H, 2022 (2)
497 participants
|
|
Ensitrelvir
413 per 1,000
(321 - 533) |
Placebo
317
per 1,000 |
|
Serious adverse events
|
RR: 0.10
(0.00 - 2.00) |
|
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, 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
Mukae H, 2022 (1); Mukae H, 2022 (2)
497 participants
|
|
Ensitrelvir
0 per 1,000
( - ) |
Placebo
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
