Table 2.
Immunoglobulin Compared with Standard Treatment for COVID-19 | ||||||
---|---|---|---|---|---|---|
Patient or Population: Adults with COVID-19 Settings: Both Outpatients and Hospitalized pts Intervention: IVIG Comparison: Standard Treatment | ||||||
Outcomes | Illustrative Comparative Risks * (95% CI) | Relative Effect (95% CI) |
No. of Participants (Studies) |
Quality of the Evidence (GRADE) |
Comments | |
Assumed Risk | Corresponding Risk | |||||
Control | IVIG | |||||
Mortality—RCTs (28 days) |
Overall population with COVID-19 | RR 0.50 (0.18/1.36) RR 0.35 (0.06/2.10) RR 0.54 (0.14/2.09) |
252 (4) 125 (2) 111 (2) |
⊕⊕⊝⊝ low 1 |
It is unclear whether IVIG reduces mortality compared to standard treatment in the overall populations of pts with COVID-19 or in moderate or severe COVID-19 pts | |
Mean mortality was 28.3% | 14.5% (5.0/38.4%) | |||||
Low-risk population (pts with moderate disease) | ||||||
Mean mortality was 6.0% | 2.1% (0.3/12.54%) | |||||
High-risk population (pts with severe/critical disease) | ||||||
Mean mortality was 59.5% | 32.1% (8.3/124.3%) | |||||
Mortality—Cohort studies | Overall population with COVID-19 | RR 0.95 (0.61/1.50) | 6 (1630) | ⊕⊕⊝⊝ low 2 |
It is unclear whether IVIG reduces mortality compared to standard treatment in COVID-19. The differences were not significant in subgroup analyses of pts with moderate or severe disease either. | |
Mean mortality was 26.9% | 25.2% (16.4/40.3%) | |||||
Length of Hospital stay (days) |
The mean hospital stay is 12.25 | 10.1 (9.05/10.98) | RD−2.24 (−3.20/−1.27) | 4 (264) | ⊕⊕⊝⊝ low 2 |
IVIG reduces LHS compared to standard treatment. The effect was driven mostly by inclusion of pts with moderate COVID-19 infections. Indeed, in the 2 studies enrolling severe pts (see Supplementary File S2), the difference in LHS favored controls compared to IVIG (RD, 2.57; 95% CIs, 1.33/3.80; p < 0.0001; low quality of evidence), while in studies evaluating moderate pts, the difference favored IVIG compared to controls.(RR, −9.64; 95% Cis, −11.18/−8.1; p < 0.00001; low quality of certainty) |
Adverse events - Overall AE |
The mean occurrence of AE was 12.8% | 12.5% (11.6/13.4%) | RD −0.03 (−0.12/0.06) | 3 (248) | ⊕⊝⊝⊝ very-low 3 |
Mean occurrence of AE was similar in IVIG recipients and controls |
- Serious AE | The mean occurrence of serious AE was 5.9% |
5.9% (5.5/6.3%) | RR 0.00 (−0.04/0.04) | 4 (848) | ⊕⊝⊝⊝ very-low 3 |
Mean occurrence of serious AE was similar in IVIG recipients and controls |
* The basis for the assumed risk is the mean control group risk across studies. The corresponding risk (and its 95% confidence interval) was 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; RD, risk difference; AE, adverse events; IVIG, intravenous iommunoglobulin. GRADE Working Group grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. 1 Downgraded for imprecision and inconsistency. 2 Downgraded for inconsistency and ROB. 3 Downgraded for imprecision and twice downgraded for serious ROB.