TABLE 2.
Primary and secondary end-points
| Convalescent plasma | Control | Absolute difference (95% CI) | Relative risk (95% CI) | p-value | |
| Patients, n | 80 | 80 | |||
| Primary outcome | |||||
| Clinical improvement on day 28 | 49 (61.3) | 52 (65.0) | −3.7% (−18.8–11.3%) | 0.94 (0.74–1.19) | 0.623 |
| Secondary outcomes | |||||
| Death on day 14 | 10 (12.5) | 5 (6.3) | 6.2% (−3.3–16.7%) | 2.00 (0.72–5.59) | 0.186 |
| Death on day 28 | 18 (22.5) | 13 (16.3) | 6.2% (−7.5–20.5%) | 1.38 (0.73–2.63) | 0.321 |
| Ordinal scale on day 14 | 3 (1–5) | 3 (1–5) | ND | 0.679 | |
| 1=discharged | 29 (36.3) | 30 (37.5) | |||
| 2=hospitalised with no supplemental oxygen | 8 (10.0) | 5 (6.3) | |||
| 3=hospitalised with low-flow supplemental oxygen | 6 (7.5) | 8 (10.0) | |||
| 4=hospitalised with high-flow supplemental oxygen and/or noninvasive ventilation | 3 (3.8) | 3 (3.8) | |||
| 5=hospitalised plus invasive mechanical ventilation and/or extracorporeal membrane oxygenation | 24 (30.0) | 26 (32.5) | |||
| 6=death | 10 (12.5) | 5 (6.3) | |||
| Ordinal scale on day 28 | 1 (1–5) | 1 (1–5) | 0.644 | ||
| 1=discharged | 44 (55.0) | 46 (57.5) | |||
| 2=hospitalised with no supplemental oxygen | 2 (2.5) | 2 (2.5) | |||
| 3=hospitalised with low-flow supplemental oxygen | 4 (5.0) | 8 (10.0) | |||
| 4=hospitalised with high-flow supplemental oxygen and/or noninvasive ventilation | 0 (0) | 1 (1.3) | |||
| 5=hospitalised plus invasive mechanical ventilation and/or extracorporeal membrane oxygenation | 12 (15.0) | 10 (12.5) | |||
| 6=death | 18 (22.5) | 13 (16.3) | |||
| Time alive and free of respiratory support, days | 11 (0–21) | 7.5 (0–22) | −0.63 (−3.91–2.66) | ND | 0.444 |
| Duration of invasive ventilatory support, days | 12 (6.5–16.5) (n=15) | 13 (7–21) (n=17) | −1.93 (−7.76–3.80) | ND | 0.515 |
| Time from randomisation to hospital discharge, days | 10 (6–15) (n=44) | 8 (5–17.8) (n=46) | 0.25 (−2.72–3.23) | ND | 0.869 |
| Secondary outcomes | |||||
| PaO2/FiO2 ratio on day 7 | 178.7 (144.6–246.1) | 171 (137.8–255.5) | 25.2 (−30.3–80.8) | ND | 0.337 |
| SOFA score on day 7 | 3.5 (2–7) | 4 (2–7.8) | −0.28 (−1.02–0.46) | ND | 0.463 |
| NEWS2 score on day 7 | 8 (4.8–11) | 8 (4–11) | 0.25 (−0.73–1.23) | ND | 0.617 |
| NEWS2 score on day 14 | 7.5 (5–10) | 9 (7.5–11) | −1.15 (−2.37–0.08) | ND | 0.067 |
| Positive RT-PCR on day 7 | 45/59 (76.3) | 43/58 (74.1) | 2.13% (−13.6–17.9%) | 1.03 (0.84–1.27) | 0.789 |
Data are presented as n (%) or median (interquartile range), unless otherwise stated. PaO2: arterial oxygen partial pressure; FiO2; fraction of inspired oxygen; SOFA: Sepsis-Related Organ Failure Assessment; NEWS: National Early Warning Score; RT: reverse transcriptase; ND: not determined.