Control arm | Experimental arms | Standard plasma vs control | COVID-19 Convalescent Plasma vs control | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Standard of Care (N = 60) | Standard Plasma (N = 60) | COVID-19 Convalescent Plasma (N = 60) | ||||||||||
no./total no | (%) | no./total no | (%) | no./total no | (%) | Risk Ratio | (95% CI) | p | Risk Ratio | (95% CI) | p | |
Primary endpoint | ||||||||||||
30-days mortality | 12/60 | (20.0) | 15/60 | (25.0) | 14/60 | (23.3) | 1.23 | (0.63–2.37) | 0.544 | 1.13 | (0.61–2.13) | 0.694 |
Secondary endpoints | ||||||||||||
30 days-incidence of Mechanical Ventilation or death | 14/56 | (25.0) | 24/60 | (40.0) | 17/59 | (28.8) | 1.53 | (0.88–2.65) | 0.119 | 1.10 | (0.61–1.95) | 0.757 |
6-months mortality | 16/60 | (26.7) | 16/60 | (26.7) | 14/60 | (23.3) | 0.98 | (0.55–1.76) | 0.951 | 0.85 | (0.48–1.53) | 0.600 |
Sub Hazard Ratio | (95% CI) | p | Sub Hazard Ratio | (95% CI) | p | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Time (days) to seroconversion to IgG anti-SARS-CoV-2* | 3 | (2–4) | 2 | (2–4) | 2 | (2–4) | 1.38 | (0.79–2.39) | 0.255 | 1.54 | (0.89–2.66) | 0.119 |
Time (days) to RT-PCR viral clearance on plasma: median (IQR)** | 5 | (4–6) | 6 | (4–6) | 6 | (4–6) | 1.01 | (0.67–1.53) | 0.957 | 0.94 | (0.62–1.42) | 0.761 |
Time (days) to RT-PCR viral clearance on respiratory tract samples: median (IQR) | 23 | (21–28) | 28 | (20–37) | 21 | (15–22) | 0.99 | (0.56–1.77) | 0.983 | 1.24 | (0.71–2.17) | 0.457 |
OR*** | (95% CI) | p | OR*** | (95% CI) | p | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Percentage of Mechanical Ventilation days: mean (SD) | 11.58 | (26.45) | 10.37 | (22.23) | 8.81 | (22.70) | 1.03 | [0.42, 2.53] | 0.950 | 0.79 | [0.30, 2.08] | 0.638 |
Mean difference | (95% CI) | p | Mean difference | (95% CI) | p | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
SOFA score variations during hospitalization: mean (SD) **** | 0.89 | (3.61) | 0.61 | (2.83) | 0.11 | (3.38) | − 0.34 | (− 1.16, 0.48) | 0.419 | − 0.70 | (− 1.57, 0.15) | 0.107 |
IgG anti-SARS-CoV-2 variations during hospitalization: mean (SD) **** | 88.54 | (82.61) | 97.66 | (96.59) | 80.19 | (64.12) | − 2.12 | (− 24.99, 20.76) | 0.856 | − 11.47 | (− 32.97, 10.03) | 0.296 |