| Outcome |
Relative effect
(95% CI) |
Absolute effect
(95% CI)1 |
Certainty of the Evidence
(GRADE) |
Clinical improvement
D28 |
Outcome not yet measured or reported
|
1 study was identified that assessed this outcome, but no results were reported. |
Clinical improvement
D60 |
RR: 1.08
(0.92 - 1.27) |
52 more per 1000
(from 52 fewer to 176 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
Bruen C, 2022
284 participants
|
|
Auxora
705 per 1,000
(600 - 829) |
Standard care/Placebo
652
per 1,000 |
|
WHO progression score (level 7 or above)
D28 |
RR: 0.56
(0.30 - 1.04) |
106 fewer per 1000
(from 168 fewer to 10 more)
|
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 and selection of the reported results Inconsistency: Not serious Indirectness: Serious
studies from a single country, therefore results in this population might not be generalizable to other settings. Imprecision: Serious
due to wide confidence interval consistent with the possibility for benefit and the possibility for no effect/trivial effect
|
| 2 trials
Miller J, 2020; Bruen C, 2022
310 participants
|
|
Auxora
134 per 1,000
(72 - 250) |
Standard care/Placebo
240
per 1,000 |
|
WHO progression score (level 7 or above)
D60 |
RR: 0.65
(0.39 - 1.07) |
79 fewer per 1000
(from 138 fewer to 16 more)
|
Very low certainty
Reasons to downgrade
Risk of bias: Serious
Risk of bias downgraded by 1 level: some concerns regarding missing data, and selection of the reported results 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 wide confidence interval consistent with the possibility for benefit and the possibility for harm and low number of participants
|
| 1 trials
Bruen C, 2022
284 participants
|
|
Auxora
148 per 1,000
(89 - 243) |
Standard care/Placebo
227
per 1,000 |
|
All-cause mortality
D28 |
RR: 0.44
(0.23 - 0.85) |
88 fewer per 1000
(from 120 fewer to 23 fewer)
|
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 missing data 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
|
| 2 trials
Bruen C, 2022; Miller J, 2020
320 participants
|
|
Auxora
69 per 1,000
(36 - 133) |
Standard care/Placebo
156
per 1,000 |
|
All-cause mortality
D60 |
RR: 0.66
(0.38 - 1.14) |
65 fewer per 1000
(from 119 fewer to 27 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
Bruen C, 2022
284 participants
|
|
Auxora
126 per 1,000
(73 - 218) |
Standard care/Placebo
191
per 1,000 |
|
Viral negative conversion
D7 |
Outcome not yet measured or reported
|
|
Adverse events
|
RR: 1.04
(0.87 - 1.25) |
24 more per 1000
(from 79 fewer to 152 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
|
| 1 trials
Bruen C, 2022
284 participants
|
|
Auxora
634 per 1,000
(531 - 762) |
Standard care/Placebo
610
per 1,000 |
|
Serious adverse events
|
RR: 0.68
(0.47 - 0.99) |
111 fewer per 1000
(from 184 fewer to 3 fewer)
|
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 benefit and the possibility for no effect/trivial effect
|
| 1 trials
Bruen C, 2022
284 participants
|
|
Auxora
236 per 1,000
(163 - 344) |
Standard care/Placebo
348
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
