Table 1.
General characteristics of randomized controlled trials in convalescent plasma COVID-19.
| Study | Number of patients | Severity of disease intervention groupa | Severity of disease control groupa | Dosage | Antibodies concentration | Primary outcomes | Secondary outcomes | Standard of care | Results on selected endpoints | Risk of Biasb |
|---|---|---|---|---|---|---|---|---|---|---|
| Li et al. [13] | 103 | Total 52 14 in WHO-7 21 in WHO-5 15 in WHO-4 2 in WHO-3 |
Total 51 11 in WHO-7 23 in WHO-5 15 in WHO-4 1 in WHO-3 1 excluded |
4–13 mL/kg Unknown schedule of administration |
Unknow exactly concentration of NAbs. Authors argued for an approximately concentration of 1/40. IgG ≥1/640 (IgG ELISA assay in-house) |
Time to clinical improvement within 28 days (discharged alive) or reduction of 2 points on WHO-6-point scale | 28-day mortality, time to hospital discharge and clearance of viral PCR results within 72 h | Antivirals, antibiotics, steroids, human immunoglobulin, Chinese herbal medicines, or interferon |
Clinical improvement: HR 1.40 (95%CI, 0.79–2.49; P = 0.26) Mortality: OR 0.65 (95%CI, 0.29–1.46; P = 0.30) Viral load: OR 11.39 (95%CI, 3.91–33.18; P < 0.001) |
Unclear |
| Gharbharan et al. [14] | 86 | Total 43 7 in WHO-3 31 in WHO-4 or 5 8 in WHO-6 or 7 |
Total 43 1 in WHO-3 34 in WHO-4 or 5 5 in WHO-6 or 7 |
300 mL single dose. Subjects without improvement of clinical status or persistently positive RT-PCR for SARS-CoV-2 receive an additional dose in five days |
Unknow exactly concentration of NAbs. Authors argued for an approximately concentration of 1/80. IgG ≥1/640 (Wantai Biological ®) |
60-day mortality | Time to hospital discharge and improvement in 2 points on WHO-8-point scale | Chloroquine, Azithromycin, Lopinavir/Ritonavir, Tocilizumab, or Anakinra | Clinical improvement: OR 1.30 (95% CI, 0.52–3.32) Mortality: OR 0.95 (95% CI, 0.20–4.67, P = 0.95) Time to discharge: HR 0.88 (95% CI, 0.49–1.60, P = 0.68) |
Unclear |
| Balcells et al. [15] | 58 | Total 21 CALL score > 9 |
Total 24 CALL score > 9 |
200 mL in two doses separated by 24 h | Nabs 1/160 IgG titers ≥ 1/400 (ELISA Euroimmun®) |
Requirement of mechanical ventilation, hospitalization for >14 days and death | 30-day mortality, requirement of MCV, days of MCV, total days of HFNC requirement, total days oxygen requirement, total days of intensive and/or intermediate care requirement, Total days of hospital stay, and SOFA score at days 3 and 7 | Steroids, Tocilizumab, Hydroxychloroquine, Lopinavir/Ritonavir, Thromboprophylaxis, or Heparin | Clinical improvement: OR 0.51 (95% CI, 0.13–2.05, P = 0.55) Mortality: OR 3.04 (95% CI, 0.54–17.2, P = 0.25) Mechanical ventilation: OR 2.98 (95% CI, 0.41–21.57, P = 0.25) |
High |
| Avendaño-Solà et al. [16] | 81 | Total 38 10 in WHO-3 28 in WHO-4 |
Total 43 13 in WHO-3 30 in WHO-4 |
250–300 mL single dose | NAbs ≥ 1/109 IgG ratio ≥ 1.1 (ELISA Euroimmun®) unknown titer of antibodies. |
Proportion of patients in categories 5, 6 or 7 in the WHO-7 points scale at day 15 | Mortality at days 15 and 29, Improvement in one point in the WHO scale, Duration in hospital stay, days without oxygen requirement, and days without MCV requirement |
Hydroxychloroquine, Lopinavir/Ritonavir; Azithromycin, Remdesivir, Steroids, Tocilizumab, or Heparin. | Clinical improvement: P = 0.55. Mortality: P = 0.06 |
High |
| Agarwal et al. [17] | 464 | Total 235 | Total 229 | 200 mL in two doses separated by 24 h | NAbs ≥ 1/20 | Progression to severe disease and mortality at day 28 | Clinical improvement at day 7, change in Fio2%, days on MCV, clearance of viral PCR results at day 3 and 7, improvement in WHO ordinal scale and requirement of vasopressor support | Hydroxychloroquine, Remdesivir, Lopinavir/Ritonavir, Oseltamivir, broad spectrum antibiotics, steroids, Tocilizumab, Heparin, Azithromycin, or Intravenous immunoglobulin. | Progression to severe disease: OR: 1.09 (95% CI, 0.67–1.77) Mortality: OR 1.06 (95% CI, 0.61–1.83) |
High |
a
WHO severity scale ranging from 1 (discharge) to 8 (death).
b
Overall bias analysis for main outcomes (Mortality and clinical improvement). NAbs: Neutralizing antibodies; WHO: World Health Organization; RT-PCR: reverse transcription polymerase chain reaction; SARS-CoV-2: severe acute respiratory syndrome coronavirus 2; MCV: Mechanical ventilation; HFNC: high flow nasal canula; OR: odds ratio; HR: hazard ratio.; ELISA: enzyme-linked immunosorbent assay; IgG: immunoglobulin G.