| 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: 0.33
(0.20 - 0.54) |
54 fewer per 1000
(from 64 fewer to 37 fewer)
|
Moderate certainty
Reasons to downgrade
Risk of bias: Not serious Inconsistency: Not serious Indirectness: Not serious Imprecision: Serious
due to wide confidence interval consistent with the possibility for benefit and the possibility for no effect/trivial effect
|
| 2 trials
Streinu-Cercel A, 2022; Kim JY, 2022
1531 participants
|
|
Regdanvimab (CT-P59)
27 per 1,000
(16 - 43) |
Placebo
81
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
|
| 1 trials
Streinu-Cercel A, 2022
216 participants
|
|
Regdanvimab (CT-P59)
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: 0.50
(0.05 - 5.53) |
1 fewer per 1000
(from 2 fewer to 12 more)
|
Moderate certainty
Reasons to downgrade
Risk of bias: Not serious Inconsistency: Not serious Indirectness: Not serious Imprecision: Serious
due to wide confidence interval consistent with the possibility for no effect/trivial effect and the possibility for harm
|
| 2 trials
Streinu-Cercel A, 2022; Kim JY, 2022
1531 participants
|
|
Regdanvimab (CT-P59)
1 per 1,000
(0 - 14) |
Placebo
3
per 1,000 |
|
All-cause mortality
D60 |
RR: 0.50
(0.05 - 5.53) |
2 fewer per 1000
(from 3 fewer to 14 more)
|
Moderate certainty
Reasons to downgrade
Risk of bias: Not serious Inconsistency: Not serious Indirectness: Not serious Imprecision: Serious
due to wide confidence interval consistent with the possibility for no effect/trivial effect and the possibility for harm
|
| 1 trials
Kim JY, 2022
1315 participants
|
|
Regdanvimab (CT-P59)
2 per 1,000
(0 - 17) |
Placebo
3
per 1,000 |
|
Viral negative conversion
D7 |
RR: 1.58
(1.29 - 1.93) |
99 more per 1000
(from 50 more to 159 more)
|
Moderate certainty
Reasons to downgrade
Risk of bias: Not serious Inconsistency: Not serious Indirectness: Not serious Imprecision: Serious
due to low number of participants/events
|
| 2 trials
Streinu-Cercel A, 2022; Kim JY, 2022
1446 participants
|
|
Regdanvimab (CT-P59)
271 per 1,000
(221 - 331) |
Placebo
171
per 1,000 |
|
Adverse events
|
RR: 0.98
(0.84 - 1.14) |
6 fewer per 1000
(from 49 fewer to 43 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 low number of participants/events
|
| 2 trials
Streinu-Cercel A, 2022; Kim JY, 2022
1531 participants
|
|
Regdanvimab (CT-P59)
300 per 1,000
(257 - 349) |
Placebo
306
per 1,000 |
|
Serious adverse events
|
RR: 1.58
(0.61 - 4.11) |
5 more per 1000
(from 4 fewer to 28 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
Streinu-Cercel A, 2022; Kim JY, 2022
1531 participants
|
|
Regdanvimab (CT-P59)
14 per 1,000
(6 - 37) |
Placebo
9
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
