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Table 2 Study endpoints and comparisons between the experimental arms and control arm in the intention to treat population

From: Convalescent or standard plasma versus standard of care in the treatment of COVID-19 patients with respiratory impairment: short and long-term effects. A three-arm randomized controlled clinical trial

 

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

  1. IQR denotes Interquartile range, LOS length of hospital stay, and RT-PCR reverse-transcriptase–polymerase-chain-reaction
  2. *N = 68 patients without anti-SARS-CoV-2 IgG at baseline (20 Standard of Care, 19 Standard Plasma, 29 COVID-19 Convalescent Plasma). **N = 125 patients with positive RT-PCR viral RNA at baseline (41 Standard of Care, 41 Standard Plasma, 43 COVID-19 Convalescent Plasma). ***OR for an increase of 10% of Percentage of Mechanical Ventilation days ****Reported mean (SD) at day 10