Summary of findings 1. Summary of findings table ‐ Corticosteroids plus standard care compared to standard care (plus/minus placebo) for hospitalised and unvaccinated individuals with a confirmed or suspected diagnosis of symptomatic COVID‐19.
| Corticosteroids plus standard care compared to standard care (plus/minus placebo) for hospitalised and unvaccinated individuals with a confirmed or suspected diagnosis of symptomatic COVID‐19 | ||||||
| Patient or population: hospitalised and unvaccinated individuals with a confirmed or suspected diagnosis of symptomatic COVID‐19 Setting: inpatient, ICU Intervention: corticosteroids plus standard care Comparison: standard care (plus/minus placebo) | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with standard care (plus/minus placebo) | Risk with corticosteroids plus standard care | |||||
| All‐cause mortality up to 30 days | 274 per 1000 | 246 per 1000 (230 to 265) | RR 0.90 (0.84 to 0.97) | 7898 (9 RCTs) | ⊕⊕⊕⊝ Moderatea | Systemic corticosteroids probably reduce all‐cause mortality up to 30 days slightly. |
| All‐cause mortality up to 120 days | 402 per 1000 | 298 per 1000 (93 to 942) | RR 0.74 (0.23 to 2.34) | 485 (3 RCTs) | ⊕⊝⊝⊝ Very lowb | The evidence is very uncertain about the effect of systemic corticosteroids on all‐cause mortality up to 120 days. |
| Clinical improvement: discharged alive (follow‐up: 28 days) | 620 per 1000 | 664 per 1000 (639 to 688) | RR 1.07 (1.03 to 1.11) | 6786 (3 RCTs) | ⊕⊕⊝⊝ Lowc | Systemic corticosteroids may slightly increase the chance of clinical improvement: discharged alive. |
| Clinical worsening: new need for invasive mechanical ventilation or death | 282 per 1000 | 260 per 1000 (237 to 285) | RR 0.92 (0.84 to 1.01) | 5586 (2 RCTs) | ⊕⊕⊝⊝ Lowd | Systemic corticosteroids may slightly decrease the risk of clinical deterioration: new need for invasive mechanical ventilation or death. |
| Serious adverse events (follow‐up: during treatment) | We did not perform meta‐analyses because of high risk of bias, heterogeneous definitions, and underreporting. Therefore, we only present descriptive statistics: Angus 2020 shock‐dependent hydrocortisone: RR 4.11 (95% CI 0.23 to 72.98); Angus 2020 fixed‐dose hydrocortisone: RR 1.43 (95% CI 0.16 to 12.49); Tomazini 2020: RR 0.54 (95% CI 0.19 to 1.59). | 678 (2 RCTs) | ⊕⊝⊝⊝ Very lowe | The evidence is very uncertain about the effect of systemic corticosteroids on serious adverse events. | ||
| Adverse events (any grade) (follow‐up: during treatment) | We did not perform meta‐analyses because of high risk of bias, heterogeneous definitions, and underreporting. We only present descriptive statistics: Edalatifard 2020: RR 0.82 (95% CI 0.12 to 5.48); Tang 2021: RR 0.63 (95% CI 0.22 to 1.76); Tomazini 2020: RR 0.99 (95% CI 0.89 to 1.10). | 447 (3 RCTs) | ⊕⊝⊝⊝ Very lowf | The evidence is very uncertain about the effect of systemic corticosteroids on adverse events. | ||
| Hospital‐acquired infections (follow up: during treatment) | We did not perform meta‐analyses because of high risk of bias, heterogeneous definitions, and underreporting. We present descriptive statistics only: Corral‐Gudino 2021: RR 4.14 (95% CI 0.51 to 33.49); Dequin 2020: RR 0.90 (95% CI 0.60 to 1.34); Tang 2021: RR 2.00 (95% CI 0.19 to 21.24); Tomazini 2020: RR 0.75 (95% CI 0.50 to 1.15). | 598 (4 RCTs) | ⊕⊝⊝⊝ Very lowf | The evidence is very uncertain about the effect of systemic corticosteroids on hospital‐acquired infections. | ||
| Invasive fungal infections (follow‐up: during treatment) | We present descriptive statistics only because of high risk of bias: Corral‐Gudino 2021: RR 2.50 (95% CI 0.11 to 59.15). | 64 (1 RCT) | ⊕⊝⊝⊝ Very lowf | The evidence is very uncertain about the effect of systemic corticosteroids on invasive fungal infections. | ||
| *The 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. | ||||||
| See interactive version of this table: https://gdt.gradepro.org/presentations/#/isof/isof_question_revman_web_424096272361428897. | ||||||
a We downgraded one level for serious risk of bias (partly deviations from the intended intervention, selection of the reported results, missing information about the allocation concealment, baseline differences) b We downgraded one level for serious risk of bias (partly deviations from the intended intervention, selection of the reported results, missing information about the allocation concealment), one level for serious inconsistency and one level for serious imprecision (wide confidence interval, low number of participants) c We downgraded one level for serious risk of bias (partly deviations from the intended intervention, selection of the reported results, missing information about the allocation concealment) and one level for serious inconsistency. d We downgraded one level for serious risk of bias (deviations from the intended intervention, measurement of the outcome) and one level for serious inconsistency. e We downgraded two levels for very serious risk of bias (deviations from the intended intervention, missing adjustment for competing risk of death, reporting bias (the safety‐relevant outcome was not reported)) and one level for serious imprecision (fewer than 500 events). f We downgraded two levels for very serious risk of bias (deviations from the intended intervention, missing adjustment for competing risk of death, missing information about the allocation concealment, reporting bias (the safety‐relevant outcome was not reported) and one level for serious imprecision (fewer than 500 events).