| 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: 0.11
(0.01 - 1.97) |
52 fewer per 1000
(from 57 fewer to 56 more)
|
Very low certainty
Reasons to downgrade
Risk of bias: Not serious Inconsistency: Not serious Indirectness: Serious
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
Lenze E, 2020
181 participants
|
|
Fluvoxamine
6 per 1,000
(1 - 114) |
Placebo
58
per 1,000 |
|
WHO progression score (level 7 or above)
D28 |
RR: 0.32
(0.01 - 7.82) |
8 fewer per 1000
(from 11 fewer to 77 more)
|
Very low certainty
Reasons to downgrade
Risk of bias: Not serious Inconsistency: Not serious Indirectness: Serious
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
Lenze E, 2020
181 participants
|
|
Fluvoxamine
4 per 1,000
(0 - 88) |
Placebo
11
per 1,000 |
|
WHO progression score (level 7 or above)
D60 |
Outcome not yet measured or reported
|
|
All-cause mortality
D28 |
RR: 0.69
(0.38 - 1.27) |
10 fewer per 1000
(from 20 fewer to 9 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
Reis G, 2021; Lenze E, 2020
1597 participants
|
|
Fluvoxamine
23 per 1,000
(12 - 42) |
Placebo
33
per 1,000 |
|
All-cause mortality
D60 |
Outcome not yet measured or reported
|
|
Viral negative conversion
D7 |
RR: 0.7
(0.48 - 1.04) |
23 fewer per 1000
(from 40 fewer to 3 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
Reis G, 2021
1497 participants
|
|
Fluvoxamine
54 per 1,000
(37 - 80) |
Placebo
77
per 1,000 |
|
Adverse events
|
Outcome not yet measured or reported
|
1 study was identified that assessed this outcome, but no results were reported. |
Serious adverse events
|
RR: 0.19
(0.02 - 1.62) |
46 fewer per 1000
(from 55 fewer to 35 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 harm
|
| 1 trials
Lenze E, 2020
181 participants
|
|
Fluvoxamine
11 per 1,000
(1 - 91) |
Placebo
56
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
