| Outcome |
Relative effect
(95% CI) |
Absolute effect
(95% CI)1 |
Certainty of the Evidence
(GRADE) |
Viral negative conversion
D7 |
RR: 0.68
(0.38 - 1.21) |
35 fewer per 1000
(from 68 fewer to 23 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 no effect and the possibility for harm and low number of participants
|
| 1 trials
Gottlieb R, 2021
544 participants
|
|
Bamlanivimab (LY-CoV555)
75 per 1,000
(42 - 134) |
Placebo
110
per 1,000 |
|
Clinical improvement
D28 |
RR: 1.11
(0.94 - 1.32) |
60 more per 1000
(from 33 fewer to 175 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 no effect and low number of participants
|
| 1 trials
Gottlieb R, 2021
478 participants
|
|
Bamlanivimab (LY-CoV555)
607 per 1,000
(514 - 721) |
Placebo
547
per 1,000 |
|
Clinical improvement
D60 |
Outcome not yet measured or reported
|
|
WHO progression score (level 7 or above)
D28 |
Outcome not yet measured or reported
|
|
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: Not serious Inconsistency: Not serious Indirectness: Serious
studies from a single country, therefore results in this population might not be generalizable to other settings. Imprecision: Very serious
no events in both groups and low number of participants
|
| 3 trials
Chew K, 2021 (1); Chew K, 2021 (2); Gottlieb R, 2021
797 participants
|
|
Bamlanivimab (LY-CoV555)
0 per 1,000
( - ) |
Placebo
0
per 1,000 |
|
All-cause mortality
D60 |
RR:
( - ) |
Zero events in both groups
|
Very low certainty
Reasons to downgrade
Risk of bias: Not serious Inconsistency: Not serious Indirectness: Serious
studies from a single country, therefore results in this population might not be generalizable to other settings. Imprecision: Very serious
no events in both groups and low number of participants
|
| 2 trials
Chew K, 2021 (1); Chew K, 2021(2)
319 participants
|
|
Bamlanivimab (LY-CoV555)
0 per 1,000
( - ) |
Placebo
0
per 1,000 |
|
Adverse events
|
RR: 1.21
(0.82 - 1.79) |
53 more per 1000
(from 45 fewer to 199 more)
|
Low certainty
Reasons to downgrade
Risk of bias: Not serious Inconsistency: Serious
Inconsistency downgraded by 1 level: I²=:59.2% 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 very wide confidence interval consistent with the possibility for no effect and the possibility for harm and low number of participants. This outcome was not downgraded a further level, since it was alreaady downgraded for inconsistency, which also contributes to the imprecision.
|
| 3 trials
Chew K, 2021 (1); Chew K, 2021 (2); Gottlieb R, 2021
797 participants
|
|
Bamlanivimab (LY-CoV555)
305 per 1,000
(207 - 452) |
Placebo
252
per 1,000 |
|
Serious adverse events
|
RR: 0.73
(0.26 - 2.06) |
7 fewer per 1000
(from 18 fewer to 26 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, 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 and low number of participants
|
| 3 trials
Chew K, 2021 (1); Chew K, 2021 (2); Gottlieb R, 2021
797 participants
|
|
Bamlanivimab (LY-CoV555)
18 per 1,000
(6 - 51) |
Placebo
25
per 1,000 |
|
Hospitalisation or death
* |
RR: 0.76
(0.27 - 2.16) |
12 fewer per 1000
(from 37 fewer to 58 more)
|
Very low certainty
Reasons to downgrade
Risk of bias: Not serious Inconsistency: Not serious Indirectness: Serious
studies 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 and low number of participants
|
| 2 trials
Checw K, 2021 (1); Chew K, 2021 (2)
319 participants
|
|
Bamlanivimab (LY-CoV555)
38 per 1,000
(14 - 108) |
Placebo
50
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
